N/A
N=10
Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT03839641 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Overnight Respiratory Exchange Ratio — 0.832; 0.887 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High fat meal (Other); Low fat meal (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pennington Biomedical Research Center
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overnight Respiratory Exchange Ratio |
0.832; 0.887 | — |
| SECONDARY Sleep Respiratory Exchange Ratio |
0.820; 0.867 | — |
| SECONDARY Peak Increase in Respiratory Exchange Ratio |
0.057; 0.103 | — |
| SECONDARY Peak Decrease in Respiratory Exchange Ratio |
0.093; 0.025 | — |
| SECONDARY Time to Peak Respiratory Exchange Ratio |
61.9; 100.3 | — |
| SECONDARY Time to Nadir Respiratory Exchange Ratio |
274; 427 | — |
| SECONDARY Slope of Respiratory Exchange Ratio |
-0.042; -0.028 | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03839641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.