Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber (METFLEX)

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Pennington Biomedical Research Center

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Treatments

Other: High fat meal
Other: Low fat meal

Study type

Interventional

Funder types

Other

Identifiers

NCT03839641
PBRC 2018-029

Details and patient eligibility

About

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).

Enrollment

10 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

10 participants in 2 patient groups

High Fat Meal First
Experimental group
Description:
Arm 1 participants randomized to receive high fat meal first, and low fat meal second
Treatment:
Other: Low fat meal
Other: High fat meal
High Fat Meal Second
Experimental group
Description:
Arm 2 participants randomized to receive low fat meal first, and high fat meal second
Treatment:
Other: Low fat meal
Other: High fat meal

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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