An interventional study of Time-restricted eating in Overweight and Obesity and PreDiabetes, sponsored by Kristine Færch. Completed at 1 site in Denmark. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-18.
Sponsored by Kristine Færch · Not applicable, Interventional, and Prevention
The aim of the present study is to investigate effects of 12 weeks time-restricted eating on behaviour and metabolism in individuals with overweight or obesity at high risk of type 2 diabetes.
Overweight and obese individuals with pre-diabetes or with a family history of diabetes or cardiovascular disease (CVD) are at high risk for developing type 2 diabetes (T2D) and CVD. Current prevention and treatment of obesity and T2D include energy restricted diets and increased levels of physical activity; however, adequate adherence to such strategies is difficult, and maintenance is challenging for most individuals, which stresses the need for feasible and sustainable interventions.
Circadian rhythms of behaviour and metabolism are closely related to the daily light/dark cycle and sleep-wake patterns and timing of food intake and fasting periods may affect the circadian rhythms of metabolic organs. In an evolutionary perspective, the pattern of food consumption has been characterised by periods of caloric intake when food was available and subsequent periods of fasting 9. This cyclic pattern leads to cycles of absorption and storage of energy and utilisation of the energy for e.g. tissue repair, stress resistance and vitality where expression of metabolic regulators coordinates with cellular processes, leading to efficient metabolism 10. Factors including the 24-hour availability of energy-dense foods, busy time schedules, different eating and sleep patterns during weekdays and weekends (i.e. 'social jetlag') challenge the feeding-fasting paradigm. Recent data suggest that an erratic diurnal eating pattern characterised by food intake largely spread throughout hours awake (≥15 h) and a concomitant short fasting period is highly prevalent in humans and animal suggest that circadian misalignment of food intake is associated with adverse metabolic effects. A number of animal studies and a few small studies in humans have reported promising effects of time-restricted eating (TRE), without concomitant dietary restrictions, on body weight and other cardiometabolic risk factors. There is a lack of randomized controlled trials investigating effect of TRE in individuals at high risk of type 2 diabetes and cardiovascular diseases.
The aim of the present study is to investigate effects of 12 weeks TRE on behaviour and metabolism in individuals with overweight or obesity at high risk of type 2 diabetes. Maintenance will be assessed at a follow-up visit 13 weeks after completion of the trial (26 weeks). Testing will be conducted at baseline and after 6, 12, and 26 weeks. Participants are instructed to follow randomization during one week assessment periods after testing at 6 and 12 weeks. Therefore, the total duration of the intervention is 13 weeks.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 100 is above the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →Kristine Færch is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion criteria
Specific exclusion criteria for participants receiving SmartPillTM (n=60)
Control group for 13 weeks (n=50). Participants will receive advice about a healthy lifestyle according to the national dietary recommendations from the Danish Health Authority.
Time-restricted eating for 13 weeks (n=50). In addition to the intervention, participants will receive advice about a healthy lifestyle according to the national dietary recommendations from the Danish Health Authority.
Other: Time-restricted eating
Participants will be instructed to eat within a self-selected 10-hour timeframe between 6AM and 8PM every day. All food/beverages except water must be consumed within the time-interval. Staff will help participants select a time-interval that fits into their daily life and optimally fulfil the following guiding principles: 1. The first food item/beverage of the day should optimally be ingested at least 2 hours after usual wake-up time 2. The last food item/beverage of the day should optimally be ingested at least 3 hours before usual bed time Diet is ad libitum and with no further dietary restrictions. Participants will receive advice about a healthy lifestyle according to the national dietary recommendations from the Danish Health Authority.
Change in body weight (kg)
Measured in fasted state on a digital scale
Time frame: Change from baseline to the end of the intervention (after 12 weeks)
Body weight (kg)
Measured on a digital scale
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)
Body mass index (kg/m^2)
Calculated from body weight (kg) and height (m)
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)
Fat mass (kg)
Measured by Dual-energy X-ray Absorptiometry
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)
Fat free mass (kg)
Measured by Dual-energy X-ray Absorptiometry
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)
Fat percentage (%)
Measured by Dual-energy X-ray Absorptiometry
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)
Waist circumference (cm)
Measured using tape measure
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)
Hip circumference (cm)
Measured using tape measure
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)
HbA1c (mmol/mol and %)
Assessed from blood samples at all visits
Time frame: Changes from baseline. All four visits (Baseline and after 6, 12, and 26 weeks)
Systolic blood pressure (mmHg)
Measured under resting and fasting conditions
Time frame: Changes from baseline. Measured at all four visits (Baseline and after 6, 12, and 26 weeks)
Diastolic blood pressure (mmHg)
Measured under resting and fasting conditions
Time frame: Changes from baseline. Measured at all four visits (Baseline and after 6, 12, and 26 weeks)
Heart rate (bpm)
Measured under resting and fasting conditions during measurements of blood pressure and in the supine position by a handheld ECG measuring device (Vagus™)
Time frame: Changes from baseline. Measured at all four visits (Baseline and after 6, 12, and 26 weeks)
Resting energy expenditure (kcal/day)
Measured by indirect calorimetry under resting and fasting conditions
Time frame: Changes from baseline. Measured at visits at baseline and after 12 weeks
Substrate oxidation (respiratory exchange ratio)
Measured by indirect calorimetry under resting and fasting conditions
Time frame: Changes from baseline. Measured at visits at baseline and after 12 weeks
Metabolites
Fasting and postprandial (after a standard mixed breakfast meal) concentrations of metabolites including but not limited to: glucose, lipids, cholesterol, free-fatty acids, and amino acids
Time frame: Changes from baseline. Measured in the blood in the fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test (4 hours) at baseline and end of the intervention (after 12 weeks)
Hormones
Fasting and postprandial (after a standard mixed breakfast meal) concentrations of hormones related to regulation of appetite, glucose and lipid metabolism (including but not limited to: insulin, glucagon, ghrelin, glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP) and peptide YY (PYY), leptin, fibroblast growth factor 19 (FGF-19), fibroblast growth factor 21 (FGF-21), growth differentiation factor 15 (GDF-15)).
Time frame: Changes from baseline. Measured in the blood in the fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test (4 hours) at baseline and end of the intervention (after 12 weeks)
Circulating proteins that associate with low-grade inflammation and lipid metabolism
Fasting levels of circulating proteins that associate with low-grade inflammation and lipid metabolism. Such proteins are captured by mass-spectrometry driven analyses of the plasma proteome i.e. proteins circulating in the blood
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks)
Respiratory and glycolytic capacities of isolated peripheral blood mononuclear cells (PBMCs)
Measured using the Seahorse method, which measures mitochondrial respiration
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks)
Heart rate response to standing up from the supine position
Measured by a handheld ECG measuring device (Vagus™).
Time frame: Changes from baseline. Measured at visits at baseline and end of the intervention (after 12 weeks)
Heart rate response to inhalation and exhalation
Measured by a handheld ECG measuring device (Vagus™).
Time frame: Changes from baseline. Measured at visits at baseline and end of the intervention (after 12 weeks)
Heart rate response to forced exhalation during rest (valsalva maneuver)
Measured by a handheld ECG measuring device (Vagus™).
Time frame: Changes from baseline. Measured at visits at baseline and end of the intervention (after 12 weeks)
Gastric emptying time (hours and minutes)
Measured using the SmartPill™ technique. The SmartPill™ is ingested together with a standard mixed breakfast meal
Time frame: Changes from baseline. Time after consumption of the standard mixed meal at baseline and end of the intervention (after 12 weeks).
Small bowel transit time (hours and minutes)
Measured using the SmartPill™ technique. The SmartPill™ is ingested together with a standard mixed breakfast meal
Time frame: Changes from baseline. Time after consumption of the standard mixed meal at baseline and end of the intervention (after 12 weeks).
Large bowel transit time (hours and minutes)
Measured using the SmartPill™ technique. The SmartPill™ is ingested together with a standard mixed breakfast meal
Time frame: Changes from baseline. Time after consumption of the standard mixed meal at baseline and end of the intervention (after 12 weeks).
Total gastrointestinal transit time (hours and minutes)
Measured using the SmartPill™ technique. The SmartPill™ is ingested together with a standard mixed breakfast meal
Time frame: Changes from baseline. Time after consumption of the standard mixed meal at baseline and end of the intervention (after 12 weeks).
Motility index
Calculated based on amplitudes and number of contractions measured using the SmartPill™ technique. The SmartPill™ is ingested together with a standard mixed breakfast meal
Time frame: Changes from baseline. Time after consumption of the standard mixed meal at baseline and end of the intervention (after 12 weeks).
Attention measured using eye tracking
Eye tracking metrics including gaze duration bias, gaze direction bias, fixations, saccades, pupil size/dilation, distance to screen, ocular vergence and blinks to measure attention in response to looking at food pictures during the computerized Leeds Food Preference Questionnaire
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks)
Emotions measured using facial expression analyses
Facial expression analyses using computer-vision algorithms (AFFDEX) to measure emotions in response to looking at food pictures during the computerized Leeds Food Preference Questionnaire
Time frame: Changes from baseline. Fasted state at all four visits (baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks)
Arousal measured using galvanic skin response
Changes in conductivity of the skin (galvanic skin response) in response to looking at food pictures during the computerized Leeds Food Preference Questionnaire
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks)
Food choice
Food choice of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the computerized Leeds Food Preference Questionnaire. Food choice is determined based on frequency of selection made within each food category. The scores range from 0-48 i.e. 0 = foods within a specific food category have not been selected at all to 48 = foods within a specific food category have been selected 48 times
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks)
Implicit wanting
Implicit wanting of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the computerized Leeds Food Preference Questionnaire. Implicit wanting is assessed based on food choice and response time for selected and non-selected food items as well as mean response time.
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks)
Explicit liking
Explicit liking of 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the computerized Leeds Food Preference Questionnaire. Explicit liking is rated using visual analogue scales and the range is 0-100. Each end represents the extremes e.g. Question: "how pleasant would it be to taste this food right now?" Answer: "not at all" (rated 0 on the 0-100 scale) to "extremely" (rated 100 on the 0-100 scale)
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks)
Explicit wanting
Explicit wanting of 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the computerized Leeds Food Preference Questionnaire. Explicit wanting is rated using visual analogue scales and the range is 0-100. Each end represents the extremes e.g. Question: "how much do you want some of this food now?" Answer: "not at all" (rated 0 on the 0-100 scale) to "extremely" (rated 100 on the 0-100 scale).
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks)
Insulin sensitivity (indices)
Including but not limited to the Matsuda index
Time frame: At all four visits (Baseline and after 6, 12, and 26 weeks)
Insulin resistance (indices)
Including but not limited to Homeostaic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame: At all four visits (Baseline and after 6, 12, and 26 weeks)
Subjective appetite
Rated using visual analogue scales and includes sensations of: Hunger, fullness, satiety, prospective food consumption, wellbeing, nausea, thirst, desire to eat meat, salty, and sweet. The scale range is 0-100 and each end represent the extremes e.g. hunger rating: "I am not hungry at all" to "I have nerver been this hungry before".
Time frame: Changes from baseline. Fasted state at all four visits (Baseline and after 6, 12, and 26 weeks) and during a mixed meal test at baseline and end of the intervention (after 12 weeks)
Mean amplitude of glycaemic excursions (MAGE)
Measured using continous glucose monitoring
Time frame: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks
Continuous overall net glycaemic action (CONGA)
Measured using continous glucose monitoring
Time frame: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks
Daily time spent above different glucose concentrations (e.g. >6.1 mmol/L, >7.0 mmol/L, >7.8 mmol/L, and >11.1 mmol/L)
Measured using continous glucose monitoring.
Time frame: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks
Mean glucose concentrations
Measured using continous glucose monitoring.
Time frame: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks
Standard deviation of glucose concentrations
Measured using continous glucose monitoring.
Time frame: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks
Variation coefficients of glucose concentrations
Measured using continous glucose monitoring.
Time frame: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks
Physical activity (time spent at different intensities)
Sedentary time, light, moderate and vigorous intensity physical activity. Assessed from 24 h/day accelerometry
Time frame: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks
Physical activity (counts/min)
Assessed from 24 h/day accelerometry
Time frame: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks
Physical activity energy expenditure (kcal/day)
Assessed from 24 h/day accelerometry
Time frame: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks
Physical activity (MET hours)
Assessed from 24 h/day accelerometry
Time frame: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks
Timing of physical activity (hh:mm)
Assessed from activity logs and 24 h/day accelerometry
Time frame: Changes from baseline. Measured 7 days after the test days at baseline and after 6 and 12 weeks
Energy intake (kcal/day)
Assessed from diet records
Time frame: Changes from baseline. Registered 3 days after the test days at baseline and after 6 and 12 weeks
Macronutrient intake (energy percentage)
Assessed from diet records
Time frame: Changes from baseline. Registered 3 days after the test days at baseline and after 6 and 12 weeks
Timing of dietary intake (hh:mm)
Assessed from diet records
Time frame: Changes from baseline. Registered 3 days after the test days at baseline and after 6 and 12 weeks
Sleep timing (hh:mm)
Including bedtime, sleep onset, wake-up, time out of bed, sleep midpoint. Assessed from sleep logs and 24 h/day accelerometry
Time frame: Changes from baseline. Registered and measured for 7 days after the test days at baseline and after 6 and 12 weeks
Sleep duration (min)
Assessed from sleep logs and 24 h/day accelerometry
Time frame: Changes from baseline. Registered and measured for 7 days after the test days at baseline and after 6 and 12 weeks
Sleep variability (min)
Variability in bedtime, wake-up, sleep duration and sleep midpoint. Assessed from sleep logs and 24 h/day accelerometry
Time frame: Changes from baseline. Registered and measured for 7 days after the test days at baseline and after 6 and 12 weeks
Sleep onset latency (min)
Assessed from sleep logs and 24 h/day accelerometry
Time frame: Changes from baseline. Registered and measured for 7 days after the test days at baseline and after 6 and 12 weeks
Sleep efficiency (%)
Assessed from 24 h/day accelerometry
Time frame: Changes from baseline. Measured for 7 days after the test days at baseline and after 6 and 12 weeks
Wakefulness (min)
Assessed from 24 h/day accelerometry
Time frame: Changes from baseline. Measured for 7 days after the test days at baseline and after 6 and 12 weeks
Self-reported gastrointestinal symptoms (part 1)
Assessed from the questionnaires the Gastrointestinal Symptom Rating Scale (GSRS). Rated on 7-point likert scales. Range: 1 = absence of symptoms to 7 = very severe symptoms.
Time frame: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks)
Self-reported gastrointestinal symptoms (part 2)
Assessed from the Gastrointestinal Symptom Score (PAGI-SYM). Rated on 6-point likert scales. Range: 1 = absence of symptoms to 6 = very severe symptoms.
Time frame: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks)
Self-reported gastrointestinal symptoms (part 3)
Number of symptoms. Assessed from logs.
Time frame: Changes from baseline. Registered 7 days after the test days at baseline and after 12 weeks
Self-reported autonomic symptoms
Assessed from the questionnaire COMPASS31
Time frame: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks)
Self-reported control over eating
Assessed from the questionnaire Control over Eating Questionnaire
Time frame: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks)
Self-reported sleepiness
Assessed from the questionnaire the Epworth Sleepiness Scale
Time frame: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks)
Self-reported sleep quality
Assessed from the questionnaire Pittsburgh Sleep Quality Index
Time frame: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks)
Self-reported chronotype
Assessed from the Munich Chronotype Questionnaire
Time frame: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks)
Self-reported physical activity
Assessed from questionnaire International Physical Activity Questionnaire
Time frame: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks)
Self-reported overall health and wellbeing
Assessed from the questionnaire Self-reported health (SF-36 health survey)
Time frame: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks)
Self-reported eating behavior
Assessed from The Dutch Eating Behavior Questionnaire
Time frame: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks)
Self-reported night eating
Assessed from The Night Eating Questionnaire
Time frame: Changes from baseline. Assessed at all four visits (Baseline and after 6, 12, and 26 weeks)
Daily eating/drinking window (hh:min)
Time of first and last meal/beverage
Time frame: Registrered every day (13 weeks intervention and 13 weeks follow-up period)
Microbiome content and diversity
Determined from stool samples. Bacterial DNA and RNA will be purified from the stool samples and changes in the microbiome composition and function will be estimated based on sequencing of the microbiomes' DNA and RNA. Includes but is not limited to the Firmicute/Bacteroidete ratio.
Time frame: Changes from baseline. Collected before or during test days at visits at baseline and after 12 weeks
Motivation for participation (qualitative methods)
Themes and aspects related to motivation for participation will be assessed based on interviews with the participants including completers and potential drop-outs.
Time frame: Visits at baseline and after 12 and 26 weeks. Potential drop-outs will be interviewed at the specific time point.
Feasibility of the intervention (qualitative methods)
Themes and aspects related to feasibility of the intervention will be assessed based on interviews with the participants including completers and potential drop-outs.
Time frame: Visits at baseline and after 12 and 26 weeks. Potential drop-outs will be interviewed at the specific time point.
Satisfaction with the intervention (qualitative methods)
Themes and aspects related to satisfaction with the intervention will be assessed based on interviews with the participants including completers and potential drop-outs.
Time frame: Visits at baseline and after 12 and 26 weeks. Potential drop-outs will be interviewed at the specific time point.
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Kristine Færch