An interventional study of High fat meal and Low fat meal in Diabetes Mellitus, Type 2, sponsored by Pennington Biomedical Research Center. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-17.
Sponsored by Pennington Biomedical Research Center · Not applicable, Interventional, and Basic science
The overarching aim of this study: To determine the effect of different meal compositions (high- vs. low-fat) on metabolic flexibility as it relates to meal-stimulated change in respiratory quotient (ΔRQ1) and sleep (ΔRQ2) metabolic flexibility, as well as the time course changes in respiratory quotient, RQ (i.e., peak RQ, time to peak RQ, nadir RQ, time to nadir, slope).
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 10 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Pennington Biomedical Research Center is the lead sponsor of 277 studies on the registry; 29 are open to participants now.
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Eligibility criteria include:
Exclusion Criteria:
Participants are ineligible to participate (or will be excluded from participating in this study) if they meet any of the following criteria:
Arm 1 participants randomized to receive high fat meal first, and low fat meal second
Other: High fat meal · Other: Low fat meal
Arm 2 participants randomized to receive low fat meal first, and high fat meal second
Other: High fat meal · Other: Low fat meal
60% fat meal
20% fat meal
Overnight Respiratory Exchange Ratio
12-h mean of respiratory exchange ratio following each meal type. measurement interval = 12h following start of meal (7pm) The respiratory exchange ratio refers to the proportion of macronutrients being oxidized. A respiratory exchange ratio value of 1.0 indicates only carbohydrates are being oxidized, while a ratio value of 0.7 indicates only fats are being oxidized. Intermediate values, such as 0.85, indicates that both carbohydrate and fats are being oxidized.
Time frame: 12 hours
Sleep Respiratory Exchange Ratio
mean of respiratory exchange ratio following each meal type during sleep period, 2am-5am., 2am-5am. measurement interval = 3h (2am-5am) The respiratory exchange ratio refers to the proportion of macronutrients being oxidized. A respiratory exchange ratio value of 1.0 indicates only carbohydrates are being oxidized, while a ratio value of 0.7 indicates only fats are being oxidized. Intermediate values, such as 0.85, indicates that both carbohydrate and fats are being oxidized.
Time frame: 3 h
Peak Increase in Respiratory Exchange Ratio
mean of peak increase in respiratory exchange ratio (Peak values - baseline values) following each meal type Peak values were defined as the peak respiratory exchange ratio value measured during the post-meal period, 6pm-10pm. Baseline values were measured 1h prior to meal (5:00-5:45pm) measurement interval of peak values= 4h (6pm-10pm) A larger value in this measurement indicates that more carbohydrate than fats were being oxidized as fuel during the measurement period.
Time frame: 4 h
Peak Decrease in Respiratory Exchange Ratio
mean of peak decrease in respiratory exchange ratio (baseline values -nadir values) following each meal type Peak values were defined as the peak respiratory exchange ratio value measured during the post-meal period, 6pm-10pm. Baseline values were measured 1h prior to meal (5:00-5:45pm) measurement interval of nadir values= 12h (6pm-6am) A larger value in this measurement indicates that more fats than carbohydrate were being oxidized as fuel during the measurement period.
Time frame: 12 h
Time to Peak Respiratory Exchange Ratio
Average time from meal to peak respiratory exchange ratio value This measurement indicates how long on average it took form the onset of the meal, 6pm, for the participants to achieve their highest/peak respiratory exchange ratio value.
Time frame: 12 h
Time to Nadir Respiratory Exchange Ratio
Average time from meal to nadir respiratory exchange ratio value This measurement indicates how long on average it took form the onset of the meal, 6pm, for the participants to achieve their lowest/nadir respiratory exchange ratio value.
Time frame: 12 h
Slope of Respiratory Exchange Ratio
This value indicates the speed and magnitude of the participants change in respiratory exchange ratio between the peak and nadir values. A more negative value in this measurement indicates either a short time interval between the highest and lowest respiratory exchange ratio values measured and/or a large difference between the highest and lowest values of respiratory exchange ratio values measured.
Time frame: 12 h
| Milestone | High-fat Meal, Washout (5-7 Days), and Low-fat Meal | Low-fat Meal, Washout (5-7 Days), and High-fat Meal |
|---|---|---|
| Started | 5 | 5 |
| Completed | 4 | 4 |
| Not completed | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
12-h mean of respiratory exchange ratio following each meal type. measurement interval = 12h following start of meal (7pm) The respiratory exchange ratio refers to the proportion of macronutrients being oxidized. A respiratory exchange ratio value of 1.0 indicates only carbohydrates are being oxidized, while a ratio value of 0.7 indicates only fats are being oxidized. Intermediate values, such as 0.85, indicates that both carbohydrate and fats are being oxidized.
| ratio | High Fat Meal | Low-fat Meal |
|---|---|---|
| Overnight Respiratory Exchange Ratio | 0.832 ± 0.014 | 0.887 ± 0.017 |
mean of respiratory exchange ratio following each meal type during sleep period, 2am-5am., 2am-5am. measurement interval = 3h (2am-5am) The respiratory exchange ratio refers to the proportion of macronutrients being oxidized. A respiratory exchange ratio value of 1.0 indicates only carbohydrates are being oxidized, while a ratio value of 0.7 indicates only fats are being oxidized. Intermediate values, such as 0.85, indicates that both carbohydrate and fats are being oxidized.
| ratio | High Fat Meal | Low-fat Meal |
|---|---|---|
| Sleep Respiratory Exchange Ratio | 0.820 ± 0.016 | 0.867 ± 0.034 |
mean of peak increase in respiratory exchange ratio (Peak values - baseline values) following each meal type Peak values were defined as the peak respiratory exchange ratio value measured during the post-meal period, 6pm-10pm. Baseline values were measured 1h prior to meal (5:00-5:45pm) measurement interval of peak values= 4h (6pm-10pm) A larger value in this measurement indicates that more carbohydrate than fats were being oxidized as fuel during the measurement period.
| ratio | High Fat Meal | Low-fat Meal |
|---|---|---|
| Peak Increase in Respiratory Exchange Ratio | 0.057 ± 0.030 | 0.103 ± 0.025 |
mean of peak decrease in respiratory exchange ratio (baseline values -nadir values) following each meal type Peak values were defined as the peak respiratory exchange ratio value measured during the post-meal period, 6pm-10pm. Baseline values were measured 1h prior to meal (5:00-5:45pm) measurement interval of nadir values= 12h (6pm-6am) A larger value in this measurement indicates that more fats than carbohydrate were being oxidized as fuel during the measurement period.
| ratio | High Fat Meal | Low-fat Meal |
|---|---|---|
| Peak Decrease in Respiratory Exchange Ratio | 0.093 ± 0.031 | 0.025 ± 0.038 |
Average time from meal to peak respiratory exchange ratio value This measurement indicates how long on average it took form the onset of the meal, 6pm, for the participants to achieve their highest/peak respiratory exchange ratio value.
| minutes | High Fat Meal | Low-fat Meal |
|---|---|---|
| Time to Peak Respiratory Exchange Ratio | 61.9 ± 13.3 | 100.3 ± 45.4 |
Average time from meal to nadir respiratory exchange ratio value This measurement indicates how long on average it took form the onset of the meal, 6pm, for the participants to achieve their lowest/nadir respiratory exchange ratio value.
| minutes | High Fat Meal | Low-fat Meal |
|---|---|---|
| Time to Nadir Respiratory Exchange Ratio | 274 ± 12.8 | 427 ± 113 |
This value indicates the speed and magnitude of the participants change in respiratory exchange ratio between the peak and nadir values. A more negative value in this measurement indicates either a short time interval between the highest and lowest respiratory exchange ratio values measured and/or a large difference between the highest and lowest values of respiratory exchange ratio values measured.
| ratio/minute | High Fat Meal | Low-fat Meal |
|---|---|---|
| Slope of Respiratory Exchange Ratio | -0.042 ± 0.007 | -0.028 ± 0.016 |
Collected over From enrollment through study completion, an average of 20 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High-fat Meal | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) |
| Low-fat Meal | 0/8 (0%) | 0/8 (0%) | 2/8 (25%) |
| Event | High-fat Meal | Low-fat Meal |
|---|---|---|
| muscle acheMusculoskeletal and connective tissue disorders | 0/8 | 1/8 |
| menstrual crampsReproductive system and breast disorders | 0/8 | 1/8 |
| sinus congestionRespiratory, thoracic and mediastinal disorders | 1/8 | 0/8 |
| sore throatRespiratory, thoracic and mediastinal disorders | 1/8 | 0/8 |
| Age, Continuous(years) | High-fat Meal, Washout (5-7 Days), and Low-fat Meal | Low-fat Meal, Washout (5-7 Days), and High-fat Meal | Total |
|---|---|---|---|
| Mean | 28 ± 7.5 | 27 ± 5.7 | 28 ± 6.3 |
| Sex: Female, Male(Participants) | High-fat Meal, Washout (5-7 Days), and Low-fat Meal | Low-fat Meal, Washout (5-7 Days), and High-fat Meal | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 2 | 2 | 4 |
| Race (NIH/OMB)(Participants) | High-fat Meal, Washout (5-7 Days), and Low-fat Meal | Low-fat Meal, Washout (5-7 Days), and High-fat Meal | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 3 | 4 | 7 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | High-fat Meal, Washout (5-7 Days), and Low-fat Meal | Low-fat Meal, Washout (5-7 Days), and High-fat Meal | Total |
|---|---|---|---|
| United States | 4 | 4 | 8 |
| baseline respiratory exchange ratio(ratio) | High-fat Meal, Washout (5-7 Days), and Low-fat Meal | Low-fat Meal, Washout (5-7 Days), and High-fat Meal | Total |
|---|---|---|---|
| Mean | 0.845 ± 0.018 | 0.856 ± 0.026 | 0.851 ± 0.023 |
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Pennington Biomedical Research Center