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

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

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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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