Status:
COMPLETED
Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber
Lead Sponsor:
Pennington Biomedical Research Center
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-40 years
Phase:
NA
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 (...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03839641
Start Date
January 14 2019
End Date
December 31 2020
Last Update
September 17 2021
Active Locations (1)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808-4124