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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Fat Meal First | Experimental | Arm 1 participants randomized to receive high fat meal first, and low fat meal second |
|
| High Fat Meal Second | Experimental | Arm 2 participants randomized to receive low fat meal first, and high fat meal second |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High fat meal | Other | 60% fat meal |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808-4124 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Low-fat Meal, Washout (5-7 Days), and High-fat Meal |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | ratio | 12 hours |
|
From enrollment through study completion, an average of 20 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High-fat Meal | High fat meal: 60% fat meal | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| muscle ache | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David McDougal | Pennington Biomedical Research Center | 2257630278 | DAVID.MCDOUGAL@PBRC.EDU |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 29, 2018 | Jul 24, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Low fat meal |
| Other |
20% fat meal |
|
| 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. | 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. | 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. | 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. | 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. | 12 h |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| baseline respiratory exchange ratio | 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. | Mean | Standard Deviation | ratio |
|
|
|
| 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. | Posted | Mean | Standard Deviation | ratio | 3 h |
|
|
|
| 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. | Posted | Mean | Standard Deviation | ratio | 4 h |
|
|
|
| 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. | Posted | Mean | Standard Deviation | ratio | 12 h |
|
|
|
| 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. | Posted | Mean | Standard Deviation | minutes | 12 h |
|
|
|
| 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. | Posted | Mean | Standard Deviation | minutes | 12 h |
|
|
|
| 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. | Posted | Mean | Standard Deviation | ratio/minute | 12 h |
|
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| 8 |
| 0 |
| 8 |
| 1 |
| 8 |
| EG001 | Low-fat Meal | Low fat meal: 20% fat meal | 0 | 8 | 0 | 8 | 2 | 8 |
| menstrual cramps | Reproductive system and breast disorders | Systematic Assessment |
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| sinus congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |