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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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States, 70808-4124