An interventional study of Early OGTT and Late OGTT in Non-Diabetic Disorder of Endocrine Pancreas, sponsored by Universidad de Murcia. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-16.
Sponsored by Universidad de Murcia · Not applicable, Interventional, and Prevention
The purpose of this investigation is to assess the role of melatonin receptor 1B (MTNR1B) single nucleotide polymorphism (SNP)*food timing interaction on glucose control in the deleterious effect in a vulnerable population with regular exposure to concurrent high melatonin and food intake as late night eaters (those having dinner within 2.5 h before their usual bed time). With the results from this study, we expect to advance our understanding of the role of endogenous melatonin on glucose metabolism in late night eaters and carriers of the MTNR1B risk allele, with potential implications on the guidelines to mitigate risk of type 2 diabetes in late night eaters and carriers of the MTNR1B risk allele.
Late-night dinner eating is associated with increased risk for type-2-diabetes. The underlying mechanism is unclear. One explanatory hypothesis is that the concurrence of elevated circulating melatonin and high glucose concentrations (characterizing late-eating) leads to impaired glucose-tolerance. However, to date, no study has tested the influence of physiological melatonin concentrations on glucose tolerance. The discovery of melatonin receptor MTNR1B as a diabetes risk gene provides evidence for a role of physiological levels of melatonin in glucose control.
The aim of the current study is to test the hypothesis that the concurrence of meal timing with elevated endogenous melatonin concentrations results in impaired glucose control and that this effect is stronger in homozygous MTNR1B risk carriers than in non-carriers. To do so we will test glucose tolerance using identical mixed meals under two glucose oral tolerance test (OGTT) conditions: a) delayed OGTT or Late Eating (LE): starting1 hour before their usual bed time, b) advanced OGTT or Early Eating (EE): starting 4 hours before habitual bed time, in a randomized, cross-over study design.
These findings could support a clinical application for the screening of this SNP and the possibility of implementing tailored and cost-effective behavioral interventions to prevent type 2 diabetes in vulnerable populations.
These goals will be achieved through a specific approach:
Universidad de Murcia is the lead sponsor of 77 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Oral glucose tolerance test (OGTT) in homozygous non-carriers (CC) for MTNR1B rs10830963 in Early and Late conditions
Behavioral: Early OGTT · Behavioral: Late OGTT
Oral glucose tolerance test (OGTT) in heterozygous (CG) risk allele carriers for MTNR1B rs10830963 in Early and Late conditions
Behavioral: Early OGTT · Behavioral: Late OGTT
Oral glucose tolerance test (OGTT) in homozygous (GG) risk allele carriers for MTNR1B rs10830963 in Early and Late conditions
Behavioral: Early OGTT · Behavioral: Late OGTT
Oral glucose tolerance test (OGTT) in heterozygous (CG) risk allele carriers for MTNR1B rs10830963 in Early and Late conditions
Behavioral: Early OGTT · Behavioral: Late OGTT
Oral glucose tolerance test (OGTT) in heterozygous (CG) risk allele carriers for MTNR1B rs10830963 in Early and Late conditions
Behavioral: Early OGTT · Behavioral: Late OGTT
Oral glucose tolerance test (OGTT) in heterozygous (CG) risk allele carriers for MTNR1B rs10830963 in Early and Late conditions
Behavioral: Early OGTT · Behavioral: Late OGTT
Oral glucose tolerance test using identical mixed 75 gr of glucose under early condition (4 hours before habitual bedtime)
Oral glucose tolerance test using identical mixed 75 gr of glucose under late condition (1 hour before habitual bedtime)
Area Under the Curve (AUC) Glucose
Glucose levels are measured along 120 minutes corresponding to at early and late condition in each visit. The Area Under the Curve was calculated as the sum of the area of several trapezoids. This trapezoids was obtained at times 0-30 min, 30-60 min, 60-90 min, 90-120 min. The values are the difference between the late and the early condition.
Time frame: Along 120 minutes in visits 1 and 2
Disposition Index (DI)
Disposition Index (DI) is the product of insulin sensitivity times by the amount of insulin secreted in response to blood glucose levels. Disposition index is used as a measure of beta cell function and the ability of the body to dispose of a glucose load. This index was determined by this formula: DI= CIR × ISI, where CIR is the measure Corrected Insulin Response, and ISI is Insulin Sensitivity Index. The values are the difference between the late and the early condition. Higher DI indicates an increased beta cell function and increased ability of the body to dispose of a glucose load.
Time frame: Along 120 minutes in visits 1 and 2
Corrected Insulin Response (CIR)
The measure of Corrected Insulin Response (CIR) uses the insulin and glucose levels at minute 30, integrating these values in the formula: CIR= l30/(G30 × (G30 - 70)).The values are the difference between the late and the early conditions. CIR is an index that assesses the insulin secretion capacity of B cells. A low CIR implies hyposecretion in response to glucose levels.
Time frame: At minute 30 during the visit 1 and 2.
Insulin Sensitivity Index (ISI)
Insulin Sensitivity Index is a measurement which integrates fasting glucose and insulin concentrations (0 min) and the mean of the glucose and insulin levels from 0 to 120 minutes (0, 30, 60, 90 and 120 min), from an OGTT, to measure insulin sensitivity. This formula allows its use in clinical settings as well as in large epidemiological studies. The values are the difference between the late and the early condition. Elevated ISI values typically indicate a favorable outcome. This index reflects the body's responsiveness to insulin, a hormone crucial for regulating blood sugar levels. Higher sensitivity to insulin suggests that cells efficiently utilize insulin's signals, promoting better blood sugar management. Lower ISI may lead to challenges in maintaining stable blood glucose levels and is often associated with conditions such as type 2 diabetes and metabolic syndrome.
Time frame: Along 120min in visits 1 and 2
Fasting Glucose
Fasting glucose (or basal glucose) is a simple measurement of glucose concentrations at minute 0 to see how glucose levels rise immediately after an OGTT. The values are the difference between the late and the early condition.
Time frame: At minute 0 in visit 1 and 2.
Fasting Insulin
Fasting insulin (or basal insulin) is a simple measurement of insulin concentrations at minute 0 to see how insulin levels rise immediately after an OGTT.The values are the difference between the late and the early condition.
Time frame: At minute 0 in visit 1 and 2
Serum Melatonin
Measurement of serum melatonin is made at time 0 and at time 120 in both the early and late conditions of everyone.
Time frame: At baseline and 120 minutes in visit 1 and 2
Dim Light Melatonin Onset (DLMO) at Early Condition Only
This measurement shows the decimal time of the onset of melatonin in dim light conditions. In the case of DLMO, we only performed this measure at the early condition in order to get the analysis of melatonin during 5 hours (4 hours before the habitual bedtime and 1 hour later), as it is described in literature (DOI: 10.1002/oby.23749).
Time frame: Melatonin measured every half hour for 5 hours at Early condition in all participants
Temperature Record (Mean Value 10hours Daytime)
Measured using a temperature sensor which records the temperature during 7 days. We only determined it during the washout period (neither early nor late conditions).
Time frame: For 1 week between visit 1 and 2
Activity Record (Mean Value 10hours Daytime)
During the seven days of the study, individuals wore a wristwatch in their non-dominant hand, that integrates two sensors: a temperature sensor, and an accelerometer sensor that records physical activity and body position data (G Acceleration Data Logger UA-004-64; Onset Computer, Bourne, MA, USA). Activity was expressed as the change in degrees per minute (Δ°/min). We calculated the average activity value during the 10 consecutive hours of maximum values. We only determined it during the washout period (neither early nor late conditions).
Time frame: For 1 week between visit 1 and 2
Light Exposure (Mean Value 10hours Daytime)
Measured using a light sensor during 7 days. We only determined it during the washout period (neither early nor late conditions).
Time frame: For 1 week between the visits 1 and 2
Sleep Duration
Sleep duration will be computed from self-reported. We only determined it during the washout period (neither early nor late conditions).
Time frame: For 1 week between visit 1 and 2
Total Energy Intake
Total energy intake in kcal/day will be computed with a 7-day dietary log. We only determined it during the washout period (neither early nor late conditions).
Time frame: For 1 week between visit 1 and 2
Dietary Composition
Macronutrient and micronutrient intake will be computed from 7-days of self-reported 24-hr dietary recalls. Percentage Kcal respect to the Total Energy Intake. We only determined it during the washout period (neither early nor late conditions).
Time frame: For 1 week between visit 1 and 2
Dietary Intake Timing
Food timing will be self-reported and averaged across 7-days of 24-hour dietary recalls. We only determined it during the washout period (neither early nor late conditions).
Time frame: For 1 week between visit 1 and 2
Physical Activity
Assessed using the International Physical Activity Questionnaire (IPAQ). This international questionnaire measures physical activity through the amount of energy expended carrying out physical activity i.e., Metabolic Units (MET) minutes a week. The higher the MET, the more amount of physical activity the individual performs. This allows us to classify low, moderate, or vigorous activity. 7 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 3000 MET minutes a week. We only determined it during the washout period (neither early nor late conditions). Formula for computation of Met-minutes: * Walking MET-minutes/week = 3.3 \* walking minutes \* walking "days" * Moderate MET-minutes/week = 4.0 \* moderate-intensity activity minutes \* moderate days * Vigorous MET-minutes/week = 8.0 \* vigorous-intensity activity minutes \* vigorous-intensity days
Time frame: During the week of washout
Chronotype
Assessed using the Morningness-Eveningness Questionnaire (MEQ). Its main purpose is to measure whether a person's circadian rhythm produces peak alertness in the morning, in the evening, or in between. It is a score that indicates the degree to which the individual favors the morning over the night. We only determined it during the washout period (neither early nor late conditions). Values: Min: 17 Max: 86 Explanation: 17-30: extreme eveningness 31-41: eveningness 42-58: neither 59-69: morningness 70-86: extreme morningness
Time frame: During the week of washout
Emotional Eating
Assessed using the Emotional Eating Questionnaire (EEQ). This questionnaire classifies individuals based on the relationship between food intake and emotions. Score between 0 and 30. We only determined it during the washout period (neither early nor late conditions). Explanation: 0-5: nothing emotional 5-10: less emotional 10-20: emotional 20-30: Very emotional
Time frame: During the week of washout
Sleep Quality
Assessed using the Pittsburgh Sleep Quality Index (PSQI). This questionnaire is used to quantitatively assess the quality of sleep. 7 scores are obtained that inform us about various aspects of sleep quality. We only determined it during the washout period (neither early nor late conditions). Score between 0 and 21. Total score of the questionnaire is divided into 7 items. Those items have a score from 0 (no problem) to 3 (severe problem). 0-5: sleep quality optimum 6-21: sleep disorders
Time frame: During the week of washout
Insomnia
Assessed using the Insomnia Severity Index (ISI). This questionnaire has 5 items and is used to assess the possible existence of sleep problems. According to the score obtained, a classification is made from no insomnia to severe clinical insomnia. We only determined it during the washout period (neither early nor late conditions). Score ranges between 0 and 28 Explanation: 0-7: no insomnia 8-14: subclinical insomnia 15-21: moderate insomnia 22-28: severe insomnia The higher the score, the more harmful
Time frame: During the week of washout
Depression
Assessed using the Patient Health Questionnaire (PHQ-9). This instrument aims to help the diagnosis of depression through the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), and to determine the severity of the disorder. It is made up of 9 items that refer to the last two weeks. The score ranges between 0 and 27. We only determined it during the washout period (neither early nor late conditions). 0-4: no depression 5-9: mild depression 10-14: moderate depression 15-19: moderate-severe depression 20-27: severe depression Explanation: 0-4: no depression 5-9: mild depression 10-14: moderate depression 15-19: moderate-severe depression 20-27: severe depression The higher the score, the more harmful
Time frame: During the week of washout
1457 patients were recruited from January 2017 to March 2020.
| Milestone | Early OGTT, Then Late OGTT in MTNR1B CC | Early OGTT, Then Late OGTT in MTNR1B CG | Early OGTT, Then Late OGTT in MTNR1B GG | Late OGTT, Then Early OGTT in MTNR1B CC | Late OGTT, Then Early OGTT in MTNR1B CG | Late OGTT, Then Early OGTT in MTNR1B GG |
|---|---|---|---|---|---|---|
| Started | 221 | 193 | 36 | 202 | 149 | 44 |
| Completed | 221 | 193 | 36 | 202 | 149 | 44 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Early OGTT, Then Late OGTT in MTNR1B CC | Early OGTT, Then Late OGTT in MTNR1B CG | Early OGTT, Then Late OGTT in MTNR1B GG | Late OGTT, Then Early OGTT in MTNR1B CC | Late OGTT, Then Early OGTT in MTNR1B CG | Late OGTT, Then Early OGTT in MTNR1B GG |
|---|---|---|---|---|---|---|
| Started | 221 | 193 | 36 | 202 | 149 | 44 |
| Completed | 221 | 193 | 36 | 202 | 149 | 44 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Early OGTT, Then Late OGTT in MTNR1B CC | Early OGTT, Then Late OGTT in MTNR1B CG | Early OGTT, Then Late OGTT in MTNR1B GG | Late OGTT, Then Early OGTT in MTNR1B CC | Late OGTT, Then Early OGTT in MTNR1B CG | Late OGTT, Then Early OGTT in MTNR1B GG |
|---|---|---|---|---|---|---|
| Started | 221 | 193 | 36 | 202 | 149 | 44 |
| Completed | 221 | 193 | 36 | 202 | 149 | 44 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
Glucose levels are measured along 120 minutes corresponding to at early and late condition in each visit. The Area Under the Curve was calculated as the sum of the area of several trapezoids. This trapezoids was obtained at times 0-30 min, 30-60 min, 60-90 min, 90-120 min. The values are the difference between the late and the early condition.
| mg*h/dL | Early OGTT, Then Late OGTT in MTNR1B CC | Early OGTT, Then Late OGTT in MTNR1B CG | Early OGTT, Then Late OGTT in MTNR1B GG | Late OGTT, Then Early OGTT in MTNR1B CC | Late OGTT, Then Early OGTT in MTNR1B CG | Late OGTT, Then Early OGTT in MTNR1B GG |
|---|---|---|---|---|---|---|
| AUC_Glucose_EE (Early Eating) | 278.84 ± 49.12 | 268.92 ± 48.69 | 260.66 ± 45.30 | 282.21 ± 54.89 | 274.91 ± 55.55 | 282.19 ± 56.56 |
| AUC_Glucose_LE (Late Eating) | 291.58 ± 49.73 | 300.51 ± 54.60 | 300.61 ± 61.35 | 300.70 ± 56.88 | 299.09 ± 57.74 | 320.32 ± 63.95 |
Disposition Index (DI) is the product of insulin sensitivity times by the amount of insulin secreted in response to blood glucose levels. Disposition index is used as a measure of beta cell function and the ability of the body to dispose of a glucose load. This index was determined by this formula: DI= CIR × ISI, where CIR is the measure Corrected Insulin Response, and ISI is Insulin Sensitivity Index. The values are the difference between the late and the early condition. Higher DI indicates an increased beta cell function and increased ability of the body to dispose of a glucose load.
| Index | Early OGTT, Then Late OGTT in MTNR1B CC | Early OGTT, Then Late OGTT in MTNR1B CG | Early OGTT, Then Late OGTT in MTNR1B GG | Late OGTT, Then Early OGTT in MTNR1B CC | Late OGTT, Then Early OGTT in MTNR1B CG | Late OGTT, Then Early OGTT in MTNR1B GG |
|---|---|---|---|---|---|---|
| DI_EE | 3.44 ± 3.03 | 4.59 ± 6.42 | 5.04 ± 6.14 | 3.54 ± 3.04 | 3.83 ± 3.84 | 3.96 ± 3.61 |
| DI_LE | 3.33 ± 3.66 | 2.97 ± 2.55 | 2.78 ± 1.67 | 3.19 ± 3.34 | 3.19 ± 2.50 | 3.04 ± 4.46 |
The measure of Corrected Insulin Response (CIR) uses the insulin and glucose levels at minute 30, integrating these values in the formula: CIR= l30/(G30 × (G30 - 70)).The values are the difference between the late and the early conditions. CIR is an index that assesses the insulin secretion capacity of B cells. A low CIR implies hyposecretion in response to glucose levels.
| Index | Early OGTT, Then Late OGTT in MTNR1B CC | Early OGTT, Then Late OGTT in MTNR1B CG | Early OGTT, Then Late OGTT in MTNR1B GG | Late OGTT, Then Early OGTT in MTNR1B CC | Late OGTT, Then Early OGTT in MTNR1B CG | Late OGTT, Then Early OGTT in MTNR1B GG Late OGTT, Then Early OGTT in MTNR1B CG |
|---|---|---|---|---|---|---|
| CIR_EE | 0.57 ± 0.60 | 0.70 ± 1.10 | 0.94 ± 1.41 | 0.58 ± 0.52 | 0.59 ± 0.45 | 0.53 ± 0.38 |
| CIR_LE | 0.50 ± 0.46 | 0.44 ± 0.38 | 0.46 ± 0.23 | 0.53 ± 0.60 | 0.51 ± 0.45 | 0.36 ± 0.28 |
Insulin Sensitivity Index is a measurement which integrates fasting glucose and insulin concentrations (0 min) and the mean of the glucose and insulin levels from 0 to 120 minutes (0, 30, 60, 90 and 120 min), from an OGTT, to measure insulin sensitivity. This formula allows its use in clinical settings as well as in large epidemiological studies. The values are the difference between the late and the early condition. Elevated ISI values typically indicate a favorable outcome. This index reflects the body's responsiveness to insulin, a hormone crucial for regulating blood sugar levels. Higher sensitivity to insulin suggests that cells efficiently utilize insulin's signals, promoting better blood sugar management. Lower ISI may lead to challenges in maintaining stable blood glucose levels and is often associated with conditions such as type 2 diabetes and metabolic syndrome.
| Index | Early OGTT, Then Late OGTT in MTNR1B CC | Early OGTT, Then Late OGTT in MTNR1B CG | Early OGTT, Then Late OGTT in MTNR1B GG | Late OGTT, Then Early OGTT in MTNR1B CC | Late OGTT, Then Early OGTT in MTNR1B CG | Late OGTT, Then Early OGTT in MTNR1B GG |
|---|---|---|---|---|---|---|
| ISI_EE | 7.36 ± 5.40 | 7.26 ± 4.38 | 6.42 ± 3.43 | 7.19 ± 5.02 | 7.40 ± 5.13 | 7.61 ± 3.91 |
| ISI_LE | 8.11 ± 6.98 | 8.11 ± 6.34 | 7.32 ± 4.20 | 6.99 ± 4.91 | 7.59 ± 5.22 | 8.00 ± 6.66 |
Fasting glucose (or basal glucose) is a simple measurement of glucose concentrations at minute 0 to see how glucose levels rise immediately after an OGTT. The values are the difference between the late and the early condition.
| mg/dL | Early OGTT, Then Late OGTT in MTNR1B CC | Early OGTT, Then Late OGTT in MTNR1B CG | Early OGTT, Then Late OGTT in MTNR1B GG | Late OGTT, Then Early OGTT in MTNR1B CC | Late OGTT, Then Early OGTT in MTNR1B CG | Late OGTT, Then Early OGTT in MTNR1B GG |
|---|---|---|---|---|---|---|
| Fasting glucose_EE | 85.25 ± 7.73 | 84.36 ± 7.25 | 84.05 ± 5.75 | 84.37 ± 6.84 | 84.69 ± 7.71 | 83.01 ± 4.90 |
| Fasting glucose_LE | 84.09 ± 7.15 | 84.92 ± 7.07 | 85.70 ± 6.90 | 84.70 ± 7.74 | 85.53 ± 6.8 | 83.87 ± 7.51 |
Fasting insulin (or basal insulin) is a simple measurement of insulin concentrations at minute 0 to see how insulin levels rise immediately after an OGTT.The values are the difference between the late and the early condition.
| µU/mL | Early OGTT, Then Late OGTT in MTNR1B CC | Early OGTT, Then Late OGTT in MTNR1B CG | Early OGTT, Then Late OGTT in MTNR1B GG | Late OGTT, Then Early OGTT in MTNR1B CC | Late OGTT, Then Early OGTT in MTNR1B CG | Late OGTT, Then Early OGTT in MTNR1B GG |
|---|---|---|---|---|---|---|
| Fasting insulin_EE | 6.70 ± 4.51 | 6.30 ± 4.28 | 6.88 ± 3.73 | 6.67 ± 4.73 | 6.16 ± 3.58 | 5.63 ± 3.69 |
| Fasting insulin_LE | 6.13 ± 4.48 | 5.70 ± 3.65 | 5.71 ± 2.73 | 6.50 ± 4.56 | 6.09 ± 3.83 | 5.52 ± 3.32 |
Measurement of serum melatonin is made at time 0 and at time 120 in both the early and late conditions of everyone.
| pg/mL | Early OGTT, Then Late OGTT in MTNR1B CC | Early OGTT, Then Late OGTT in MTNR1B CG | Early OGTT, Then Late OGTT in MTNR1B GG | Late OGTT, Then Early OGTT in MTNR1B CC | Late OGTT, Then Early OGTT in MTNR1B CG | Late OGTT, Then Early OGTT in MTNR1B GG |
|---|---|---|---|---|---|---|
| Melatonin_t0_EE | 20.86 ± 12.32 | 19.50 ± 9.82 | 20.25 ± 10.70 | 19.20 ± 10.39 | 19.01 ± 10.87 | 23.13 ± 14.92 |
| Melatonin_t120_EE | 25.81 ± 17.69 | 26.85 ± 22.10 | 25.72 ± 19.65 | 25.40 ± 18.03 | 21.83 ± 13.47 | 29.61 ± 26.63 |
| Melatonin_t0_LE | 52.69 ± 40.34 | 53.16 ± 43.69 | 54.24 ± 35.21 | 49.32 ± 34.39 | 47.16 ± 41.14 | 55.33 ± 32.39 |
| Melatonin_t120_LE | 79.36 ± 52.24 | 83.92 ± 60.28 | 93.83 ± 63.71 | 81.07 ± 55.86 | 74.06 ± 55.72 | 83.80 ± 44.87 |
This measurement shows the decimal time of the onset of melatonin in dim light conditions. In the case of DLMO, we only performed this measure at the early condition in order to get the analysis of melatonin during 5 hours (4 hours before the habitual bedtime and 1 hour later), as it is described in literature (DOI: 10.1002/oby.23749).
| decimal hours | Early OGTT, Then Late OGTT in MTNR1B CC | Early OGTT, Then Late OGTT in MTNR1B CG | Early OGTT, Then Late OGTT in MTNR1B GG | Late OGTT, Then Early OGTT in MTNR1B CC | Late OGTT, Then Early OGTT in MTNR1B CG | Late OGTT, Then Early OGTT in MTNR1B GG |
|---|---|---|---|---|---|---|
| Dim Light Melatonin Onset (DLMO) at Early Condition Only | 22.42 ± 1.33 | 22.03 ± 1.06 | 22.41 ± 0.92 | 22.50 ± 1.38 | 22.08 ± 1.13 | 22.39 ± 1.40 |
Measured using a temperature sensor which records the temperature during 7 days. We only determined it during the washout period (neither early nor late conditions).
| centigrade degrees | Early OGTT, Then Late OGTT in MTNR1B CC | Early OGTT, Then Late OGTT in MTNR1B CG | Early OGTT, Then Late OGTT in MTNR1B GG | Late OGTT, Then Early OGTT in MTNR1B CC | Late OGTT, Then Early OGTT in MTNR1B CG | Late OGTT, Then Early OGTT in MTNR1B GG |
|---|---|---|---|---|---|---|
| Temperature Record (Mean Value 10hours Daytime) | 32.94 ± 0.98 | 32.95 ± 1.09 | 33.24 ± 0.94 | 33.05 ± 0.98 | 32.91 ± 0.93 | 33.02 ± 0.95 |
During the seven days of the study, individuals wore a wristwatch in their non-dominant hand, that integrates two sensors: a temperature sensor, and an accelerometer sensor that records physical activity and body position data (G Acceleration Data Logger UA-004-64; Onset Computer, Bourne, MA, USA). Activity was expressed as the change in degrees per minute (Δ°/min). We calculated the average activity value during the 10 consecutive hours of maximum values. We only determined it during the washout period (neither early nor late conditions).
| changes in degrees/min (Δ°/min) | Early OGTT, Then Late OGTT in MTNR1B CC | Early OGTT, Then Late OGTT in MTNR1B CG | Early OGTT, Then Late OGTT in MTNR1B GG | Late OGTT, Then Early OGTT in MTNR1B CC | Late OGTT, Then Early OGTT in MTNR1B CG | Late OGTT, Then Early OGTT in MTNR1B GG |
|---|---|---|---|---|---|---|
| Activity Record (Mean Value 10hours Daytime) | 42.69 ± 8.51 | 51.61 ± 85.33 | 42.62 ± 6.46 | 41.73 ± 9.12 | 43.83 ± 8.06 | 44.30 ± 8.31 |
Measured using a light sensor during 7 days. We only determined it during the washout period (neither early nor late conditions).
| Lux log | Early OGTT, Then Late OGTT in MTNR1B CC | Early OGTT, Then Late OGTT in MTNR1B CG | Early OGTT, Then Late OGTT in MTNR1B GG | Late OGTT, Then Early OGTT in MTNR1B CC | Late OGTT, Then Early OGTT in MTNR1B CG | Late OGTT, Then Early OGTT in MTNR1B GG |
|---|---|---|---|---|---|---|
| Light Exposure (Mean Value 10hours Daytime) | 0.82 ± 0.24 | 0.83 ± 0.24 | 0.77 ± 0.27 | 0.81 ± 0.25 | 0.81 ± 0.25 | 0.88 ± 0.32 |
Sleep duration will be computed from self-reported. We only determined it during the washout period (neither early nor late conditions).
| decimal hours | Early OGTT, Then Late OGTT in MTNR1B CC | Early OGTT, Then Late OGTT in MTNR1B CG | Early OGTT, Then Late OGTT in MTNR1B GG | Late OGTT, Then Early OGTT in MTNR1B CC | Late OGTT, Then Early OGTT in MTNR1B CG | Late OGTT, Then Early OGTT in MTNR1B GG |
|---|---|---|---|---|---|---|
| Sleep Duration | 7.43 ± 0.75 | 7.52 ± 0.79 | 7.58 ± 0.70 | 7.56 ± 0.82 | 7.46 ± 0.88 | 7.51 ± 0.69 |
Total energy intake in kcal/day will be computed with a 7-day dietary log. We only determined it during the washout period (neither early nor late conditions).
| Kcal/day | Early OGTT, Then Late OGTT in MTNR1B CC | Early OGTT, Then Late OGTT in MTNR1B CG | Early OGTT, Then Late OGTT in MTNR1B GG | Late OGTT, Then Early OGTT in MTNR1B CC | Late OGTT, Then Early OGTT in MTNR1B CG | Late OGTT, Then Early OGTT in MTNR1B GG |
|---|---|---|---|---|---|---|
| Total Energy Intake | 1563.64 ± 529.39 | 1548.29 ± 552.64 | 1666.25 ± 633.62 | 1555.96 ± 625.39 | 1619.23 ± 695.37 | 1753.18 ± 719.78 |
Macronutrient and micronutrient intake will be computed from 7-days of self-reported 24-hr dietary recalls. Percentage Kcal respect to the Total Energy Intake. We only determined it during the washout period (neither early nor late conditions).
| percentage | Early OGTT, Then Late OGTT in MTNR1B CC | Early OGTT, Then Late OGTT in MTNR1B CG | Early OGTT, Then Late OGTT in MTNR1B GG | Late OGTT, Then Early OGTT in MTNR1B CC | Late OGTT, Then Early OGTT in MTNR1B CG | Late OGTT, Then Early OGTT in MTNR1B GG |
|---|---|---|---|---|---|---|
| Fat | 34.85 ± 7.01 | 33.95 ± 7.37 | 36.04 ± 8.25 | 33.94 ± 7.83 | 34.90 ± 8.04 | 35.85 ± 8.49 |
| Proteins | 17.52 ± 3.41 | 18.26 ± 3.94 | 18.02 ± 3.92 | 18.18 ± 3.95 | 18.24 ± 3.48 | 17.57 ± 3.65 |
| Carbohydrates | 47.17 ± 7.66 | 47.75 ± 7.42 | 46.85 ± 7.38 | 47.82 ± 8.33 | 46.64 ± 8.49 | 46.68 ± 7.58 |
Food timing will be self-reported and averaged across 7-days of 24-hour dietary recalls. We only determined it during the washout period (neither early nor late conditions).
| decimal hours | Early OGTT, Then Late OGTT in MTNR1B CC | Early OGTT, Then Late OGTT in MTNR1B CG | Early OGTT, Then Late OGTT in MTNR1B GG | Late OGTT, Then Early OGTT in MTNR1B CC | Late OGTT, Then Early OGTT in MTNR1B CG | Late OGTT, Then Early OGTT in MTNR1B GG |
|---|---|---|---|---|---|---|
| Start breakfast | 8.72 ± 0.98 | 8.68 ± 0.87 | 8.80 ± 0.92 | 8.74 ± 0.92 | 8.68 ± 0.83 | 8.66 ± 0.96 |
| Start lunch | 14.66 ± 0.49 | 14.72 ± 0.53 | 14.60 ± 0.42 | 14.70 ± 0.52 | 14.71 ± 0.48 | 14.50 ± 0.38 |
| Start dinner | 21.66 ± 0.53 | 21.61 ± 0.65 | 21.64 ± 0.49 | 21.61 ± 0.56 | 21.67 ± 0.54 | 21.54 ± 0.56 |
Assessed using the International Physical Activity Questionnaire (IPAQ). This international questionnaire measures physical activity through the amount of energy expended carrying out physical activity i.e., Metabolic Units (MET) minutes a week. The higher the MET, the more amount of physical activity the individual performs. This allows us to classify low, moderate, or vigorous activity. 7 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 3000 MET minutes a week. We only determined it during the washout period (neither early nor late conditions). Formula for computation of Met-minutes: * Walking MET-minutes/week = 3.3 \* walking minutes \* walking "days" * Moderate MET-minutes/week = 4.0 \* moderate-intensity activity minutes \* moderate days * Vigorous MET-minutes/week = 8.0 \* vigorous-intensity activity minutes \* vigorous-intensity days
| Metabolic Units (MET)-minutes/week | Early OGTT, Then Late OGTT in MTNR1B CC | Early OGTT, Then Late OGTT in MTNR1B CG | Early OGTT, Then Late OGTT in MTNR1B GG | Late OGTT, Then Early OGTT in MTNR1B CC | Late OGTT, Then Early OGTT in MTNR1B CG | Late OGTT, Then Early OGTT in MTNR1B GG |
|---|---|---|---|---|---|---|
| Physical Activity | 4066.98 ± 5898.97 | 4548.62 ± 5060.76 | 4560.41 ± 5779.47 | 4646.63 ± 4877.34 | 4429.64 ± 5284.58 | 4608.31 ± 4765.35 |
Assessed using the Morningness-Eveningness Questionnaire (MEQ). Its main purpose is to measure whether a person's circadian rhythm produces peak alertness in the morning, in the evening, or in between. It is a score that indicates the degree to which the individual favors the morning over the night. We only determined it during the washout period (neither early nor late conditions). Values: Min: 17 Max: 86 Explanation: 17-30: extreme eveningness 31-41: eveningness 42-58: neither 59-69: morningness 70-86: extreme morningness
| score | Early OGTT, Then Late OGTT in MTNR1B CC | Early OGTT, Then Late OGTT in MTNR1B CG | Early OGTT, Then Late OGTT in MTNR1B GG | Late OGTT, Then Early OGTT in MTNR1B CC | Late OGTT, Then Early OGTT in MTNR1B CG | Late OGTT, Then Early OGTT in MTNR1B GG |
|---|---|---|---|---|---|---|
| Chronotype | 51.15 ± 9.42 | 51.75 ± 8.90 | 49.83 ± 10.70 | 51.35 ± 10.15 | 51.65 ± 10.32 | 51.11 ± 8.97 |
Assessed using the Emotional Eating Questionnaire (EEQ). This questionnaire classifies individuals based on the relationship between food intake and emotions. Score between 0 and 30. We only determined it during the washout period (neither early nor late conditions). Explanation: 0-5: nothing emotional 5-10: less emotional 10-20: emotional 20-30: Very emotional
| score | Early OGTT, Then Late OGTT in MTNR1B CC | Early OGTT, Then Late OGTT in MTNR1B CG | Early OGTT, Then Late OGTT in MTNR1B GG | Late OGTT, Then Early OGTT in MTNR1B CC | Late OGTT, Then Early OGTT in MTNR1B CG | Late OGTT, Then Early OGTT in MTNR1B GG |
|---|---|---|---|---|---|---|
| Emotional Eating | 11.10 ± 6.26 | 10.64 ± 5.74 | 11.16 ± 6.32 | 10.98 ± 6.16 | 10.81 ± 6.28 | 10.54 ± 5.79 |
Assessed using the Pittsburgh Sleep Quality Index (PSQI). This questionnaire is used to quantitatively assess the quality of sleep. 7 scores are obtained that inform us about various aspects of sleep quality. We only determined it during the washout period (neither early nor late conditions). Score between 0 and 21. Total score of the questionnaire is divided into 7 items. Those items have a score from 0 (no problem) to 3 (severe problem). 0-5: sleep quality optimum 6-21: sleep disorders
| score | Early OGTT, Then Late OGTT in MTNR1B CC | Early OGTT, Then Late OGTT in MTNR1B CG | Early OGTT, Then Late OGTT in MTNR1B GG | Late OGTT, Then Early OGTT in MTNR1B CC | Late OGTT, Then Early OGTT in MTNR1B CG | Late OGTT, Then Early OGTT in MTNR1B GG |
|---|---|---|---|---|---|---|
| Sleep Quality | 6.05 ± 3.05 | 6.15 ± 3.15 | 6.75 ± 3.25 | 7.00 ± 3.74 | 6.84 ± 3.36 | 6.49 ± 3.29 |
Assessed using the Insomnia Severity Index (ISI). This questionnaire has 5 items and is used to assess the possible existence of sleep problems. According to the score obtained, a classification is made from no insomnia to severe clinical insomnia. We only determined it during the washout period (neither early nor late conditions). Score ranges between 0 and 28 Explanation: 0-7: no insomnia 8-14: subclinical insomnia 15-21: moderate insomnia 22-28: severe insomnia The higher the score, the more harmful
| score | Early OGTT, Then Late OGTT in MTNR1B CC | Early OGTT, Then Late OGTT in MTNR1B CG | Early OGTT, Then Late OGTT in MTNR1B GG | Late OGTT, Then Early OGTT in MTNR1B CC | Late OGTT, Then Early OGTT in MTNR1B CG | Late OGTT, Then Early OGTT in MTNR1B GG |
|---|---|---|---|---|---|---|
| Insomnia | 6.44 ± 4.83 | 6.63 ± 4.99 | 7.86 ± 5.48 | 7.04 ± 5.39 | 6.86 ± 5.48 | 7.29 ± 5.97 |
Assessed using the Patient Health Questionnaire (PHQ-9). This instrument aims to help the diagnosis of depression through the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), and to determine the severity of the disorder. It is made up of 9 items that refer to the last two weeks. The score ranges between 0 and 27. We only determined it during the washout period (neither early nor late conditions). 0-4: no depression 5-9: mild depression 10-14: moderate depression 15-19: moderate-severe depression 20-27: severe depression Explanation: 0-4: no depression 5-9: mild depression 10-14: moderate depression 15-19: moderate-severe depression 20-27: severe depression The higher the score, the more harmful
| score | Early OGTT, Then Late OGTT in MTNR1B CC | Early OGTT, Then Late OGTT in MTNR1B CG | Early OGTT, Then Late OGTT in MTNR1B GG | Late OGTT, Then Early OGTT in MTNR1B CC | Late OGTT, Then Early OGTT in MTNR1B CG | Late OGTT, Then Early OGTT in MTNR1B GG |
|---|---|---|---|---|---|---|
| Depression | 4.50 ± 3.89 | 4.61 ± 4.17 | 4.77 ± 4.83 | 4.98 ± 4.52 | 4.57 ± 3.63 | 5.31 ± 4.41 |
Collected over During 9 days (1 day of intervention-1 week of washout-1 day of intervention), through study completion. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Early OGTT (First) in MTNR1B CC | 0/221 (0%) | 0/221 (0%) | 0/221 (0%) |
| Early OGTT (First) in MTNR1B CG | 0/193 (0%) | 0/193 (0%) | 0/193 (0%) |
| Early OGTT (First) in MTNR1B GG | 0/36 (0%) | 0/36 (0%) | 0/36 (0%) |
| Late OGTT (First) in MTNR1B CC | 0/202 (0%) | 0/202 (0%) | 0/202 (0%) |
| Late OGTT (First) in MTNR1B CG | 0/149 (0%) | 0/149 (0%) | 0/149 (0%) |
| Late OGTT (First) in MTNR1B GG | 0/44 (0%) | 0/44 (0%) | 0/44 (0%) |
| Late OGTT (Second) in MTNR1B CC | 0/221 (0%) | 0/221 (0%) | 0/221 (0%) |
| Late OGTT (Second) in MTNR1B CG | 0/193 (0%) | 0/193 (0%) | 0/193 (0%) |
| Late OGTT (Second) in MTNR1B GG | 0/36 (0%) | 0/36 (0%) | 0/36 (0%) |
| Early OGTT (Second) in MTNR1B CC | 0/202 (0%) | 0/202 (0%) | 0/202 (0%) |
| Early OGTT (Second) in MTNR1B CG | 0/149 (0%) | 0/149 (0%) | 0/149 (0%) |
| Early OGTT (Second) in MTNR1B GG | 0/44 (0%) | 0/44 (0%) | 0/44 (0%) |
| Age, Continuous(years) | Early OGTT, Then Late OGTT in MTNR1B CC | Early OGTT, Then Late OGTT in MTNR1B CG | Early OGTT, Then Late OGTT in MTNR1B GG | Late OGTT, Then Early OGTT in MTNR1B CC | Late OGTT, Then Early OGTT in MTNR1B CG | Late OGTT, Then Early OGTT in MTNR1B GG | Total |
|---|---|---|---|---|---|---|---|
| Mean | 36 ± 13 | 39 ± 14 | 36 ± 15 | 38 ± 14 | 39 ± 15 | 37 ± 16 | 38 ± 14 |
| Sex: Female, Male(Participants) | Early OGTT, Then Late OGTT in MTNR1B CC | Early OGTT, Then Late OGTT in MTNR1B CG | Early OGTT, Then Late OGTT in MTNR1B GG | Late OGTT, Then Early OGTT in MTNR1B CC | Late OGTT, Then Early OGTT in MTNR1B CG | Late OGTT, Then Early OGTT in MTNR1B GG | Total |
|---|---|---|---|---|---|---|---|
| Female | 152 | 136 | 30 | 143 | 107 | 32 | 600 |
| Male | 69 | 57 | 6 | 59 | 42 | 12 | 245 |
| Race (NIH/OMB)(Participants) | Early OGTT, Then Late OGTT in MTNR1B CC | Early OGTT, Then Late OGTT in MTNR1B CG | Early OGTT, Then Late OGTT in MTNR1B GG | Late OGTT, Then Early OGTT in MTNR1B CC | Late OGTT, Then Early OGTT in MTNR1B CG | Late OGTT, Then Early OGTT in MTNR1B GG | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| White | 221 | 193 | 36 | 202 | 149 | 44 | 845 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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Universidad de Murcia