Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber

Pennington Biomedical Research Center10 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

High fat mealOTHER

60% fat meal

Low fat mealOTHER

20% fat meal

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Outcomes

Primary Outcomes

Overnight Respiratory Exchange Ratio

12-h mean of respiratory exchange ratio following each meal type. measurement interval = 12h following start of meal (7pm) The respiratory exchange ratio refers to the proportion of macronutrients being oxidized. A respiratory exchange ratio value of 1.0 indicates only carbohydrates are being oxidized, while a ratio value of 0.7 indicates only fats are being oxidized. Intermediate values, such as 0.85, indicates that both carbohydrate and fats are being oxidized.

Time frame: 12 hours

Secondary Outcomes

Sleep Respiratory Exchange Ratio

mean of respiratory exchange ratio following each meal type during sleep period, 2am-5am., 2am-5am. measurement interval = 3h (2am-5am) The respiratory exchange ratio refers to the proportion of macronutrients being oxidized. A respiratory exchange ratio value of 1.0 indicates only carbohydrates are being oxidized, while a ratio value of 0.7 indicates only fats are being oxidized. Intermediate values, such as 0.85, indicates that both carbohydrate and fats are being oxidized.

Time frame: 3 h

Peak Increase in Respiratory Exchange Ratio

mean of peak increase in respiratory exchange ratio (Peak values - baseline values) following each meal type Peak values were defined as the peak respiratory exchange ratio value measured during the post-meal period, 6pm-10pm. Baseline values were measured 1h prior to meal (5:00-5:45pm) measurement interval of peak values= 4h (6pm-10pm) A larger value in this measurement indicates that more carbohydrate than fats were being oxidized as fuel during the measurement period.

Time frame: 4 h

Peak Decrease in Respiratory Exchange Ratio

mean of peak decrease in respiratory exchange ratio (baseline values -nadir values) following each meal type Peak values were defined as the peak respiratory exchange ratio value measured during the post-meal period, 6pm-10pm. Baseline values were measured 1h prior to meal (5:00-5:45pm) measurement interval of nadir values= 12h (6pm-6am) A larger value in this measurement indicates that more fats than carbohydrate were being oxidized as fuel during the measurement period.

Data from ClinicalTrials.gov

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