Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber

Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber

Sponsors

Lead Sponsor: Pennington Biomedical Research Center

Source Pennington Biomedical Research Center
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, area under the curve).

Overall Status Active, not recruiting
Start Date January 14, 2019
Completion Date December 31, 2020
Primary Completion Date December 31, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
change in respiratory quotient 12 hours
Enrollment 8
Condition
Intervention

Intervention Type: Other

Intervention Name: High fat meal

Description: 60% fat meal

Intervention Type: Other

Intervention Name: Low fat meal

Description: 20% fat meal

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 40 Years

Healthy Volunteers: Accepts Healthy Volunteers

Location
Facility: Pennington Biomedical Research Center
Location Countries

United States

Verification Date

March 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Pennington Biomedical Research Center

Investigator Full Name: David McDougal

Investigator Title: Assistant Professor-Research

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: High Fat Meal First

Type: Experimental

Description: Arm 1 participants randomized to receive high fat meal first, and low fat meal second

Label: High Fat Meal Second

Type: Experimental

Description: Arm 2 participants randomized to receive low fat meal first, and high fat meal second

Acronym METFLEX
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Basic Science

Masking: Double (Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov