Diabetes Mellitus, Type 2
Conditions
Brief summary
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).
Interventions
OTHERHigh fat meal
60% fat meal
OTHERLow fat meal
20% fat meal
Sponsors
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Eligibility criteria include: * Healthy male or female * Ages 18-40 y * BMI between 20 kg/m2 and 30 kg/m2 (±0.5 kg/m2 will be accepted) * Are willing to consume pre-prepared meals * Are willing to maintain current physical activity, sleep schedule, and dietary habits during the study. * Medically cleared for participation in the study by Medical Investigator
Exclusion criteria
* Participants are ineligible to participate (or will be excluded from participating in this study) if they meet any of the following criteria: * Unstable weight in the last 3 months \[gain or loss \>7 lb (or 3.2 kg)\] * Currently working shift work * Smoking or use of tobacco products within the last 3 months * Amenorrhea (or absence of regular monthly cycles) * History of clinically diagnosed diabetes or a fasting blood glucose \>126 mg/dL * Average screening blood pressure \>140/90 mmHg * Previous bariatric surgery (or other surgeries) for obesity or weight loss * Use of medications affecting metabolism or sleep * History of neurological disease * History of cardiovascular disease (or other chronic diseases) * Pregnant, planning to become pregnant, or breastfeeding * Adherence to special restrained diets (e.g., low-carbohydrate, low-fat, or vegetarian/vegan diets) over the last 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overnight Respiratory Exchange Ratio | 12 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Increase in Respiratory Exchange Ratio | 4 h | 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. |
| Peak Decrease in Respiratory Exchange Ratio | 12 h | 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. |
| Sleep Respiratory Exchange Ratio | 3 h | 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 to Nadir Respiratory Exchange Ratio | 12 h | 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. |
| Slope of Respiratory Exchange Ratio | 12 h | 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 to Peak Respiratory Exchange Ratio | 12 h | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High-fat Meal, Washout (5-7 Days), and Low-fat Meal Arm 1 participants randomized to receive high fat meal first, and low fat meal second
High fat meal: 60% fat meal
Low fat meal: 20% fat meal | 4 |
| Low-fat Meal, Washout (5-7 Days), and High-fat Meal Arm 2 participants randomized to receive low fat meal first, and high fat meal second
High fat meal: 60% fat meal
Low fat meal: 20% fat meal | 4 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | High-fat Meal, Washout (5-7 Days), and Low-fat Meal | Low-fat Meal, Washout (5-7 Days), and High-fat Meal | Total |
|---|---|---|---|
| Age, Continuous | 28 years STANDARD_DEVIATION 7.5 | 27 years STANDARD_DEVIATION 5.7 | 28 years STANDARD_DEVIATION 6.3 |
| baseline respiratory exchange ratio | 0.845 ratio STANDARD_DEVIATION 0.018 | 0.856 ratio STANDARD_DEVIATION 0.026 | 0.851 ratio STANDARD_DEVIATION 0.023 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 4 Participants | 7 Participants |
| Region of Enrollment United States | 4 participants | 4 participants | 8 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 1 / 8 | 2 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Fat Meal | Overnight Respiratory Exchange Ratio | 0.832 ratio | Standard Deviation 0.014 |
| Low-fat Meal | Overnight Respiratory Exchange Ratio | 0.887 ratio | Standard Deviation 0.017 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Fat Meal | Peak Decrease in Respiratory Exchange Ratio | 0.093 ratio | Standard Deviation 0.031 |
| Low-fat Meal | Peak Decrease in Respiratory Exchange Ratio | 0.025 ratio | Standard Deviation 0.038 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Fat Meal | Peak Increase in Respiratory Exchange Ratio | 0.057 ratio | Standard Deviation 0.03 |
| Low-fat Meal | Peak Increase in Respiratory Exchange Ratio | 0.103 ratio | Standard Deviation 0.025 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Fat Meal | Sleep Respiratory Exchange Ratio | 0.820 ratio | Standard Deviation 0.016 |
| Low-fat Meal | Sleep Respiratory Exchange Ratio | 0.867 ratio | Standard Deviation 0.034 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Fat Meal | Slope of Respiratory Exchange Ratio | -0.042 ratio/minute | Standard Deviation 0.007 |
| Low-fat Meal | Slope of Respiratory Exchange Ratio | -0.028 ratio/minute | Standard Deviation 0.016 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Fat Meal | Time to Nadir Respiratory Exchange Ratio | 274 minutes | Standard Deviation 12.8 |
| Low-fat Meal | Time to Nadir Respiratory Exchange Ratio | 427 minutes | Standard Deviation 113 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Fat Meal | Time to Peak Respiratory Exchange Ratio | 61.9 minutes | Standard Deviation 13.3 |
| Low-fat Meal | Time to Peak Respiratory Exchange Ratio | 100.3 minutes | Standard Deviation 45.4 |