Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber

NCT03839641 | Completed Results

• 1 other identifier: PBRC 2018-029
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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.

  12 hours

Secondary Outcomes (6)

• Sleep Respiratory Exchange Ratio

  3 h

• Peak Increase in Respiratory Exchange Ratio

  4 h

• Peak Decrease in Respiratory Exchange Ratio

  12 h

• Time to Peak Respiratory Exchange Ratio

  12 h

• Time to Nadir Respiratory Exchange Ratio

  12 h

Study Arms (2)

High Fat Meal First

EXPERIMENTAL

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

Other: High fat meal; Other: Low fat meal

High Fat Meal Second

EXPERIMENTAL

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

Other: High fat meal; Other: Low fat meal

Interventions

High fat meal OTHER

60% fat meal

High Fat Meal First; High Fat Meal Second

Low fat meal OTHER

20% fat meal

High Fat Meal First; High Fat Meal Second

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808-4124, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. David McDougal
• Organization: Pennington Biomedical Research Center

DAVID.MCDOUGAL@PBRC.EDU

2257630278

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor-Research

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: January 14, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: September 17, 2021
• Results First Posted: September 17, 2021

Record last verified: 2021-08

Locations

US (1)