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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High fat meal
Low fat meal
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High Fat Meal First

High Fat Meal Second

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Time to Peak Respiratory Exchange Ratio
Average time from meal to peak respiratory exchange ratio value This measurement indicates how long on average it took form the onset of the meal, 6pm, for the participants to achieve their highest/peak respiratory exchange ratio value.
Time to Nadir Respiratory Exchange Ratio
Average time from meal to nadir respiratory exchange ratio value This measurement indicates how long on average it took form the onset of the meal, 6pm, for the participants to achieve their lowest/nadir respiratory exchange ratio value.
Slope of Respiratory Exchange Ratio
This value indicates the speed and magnitude of the participants change in respiratory exchange ratio between the peak and nadir values. A more negative value in this measurement indicates either a short time interval between the highest and lowest respiratory exchange ratio values measured and/or a large difference between the highest and lowest values of respiratory exchange ratio values measured.

Full Information

First Posted
February 11, 2019
Last Updated
August 21, 2021
Sponsor
Pennington Biomedical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT03839641
Brief Title
Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber
Acronym
METFLEX
Official Title
Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 14, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Fat Meal First
Arm Type
Experimental
Arm Description
Arm 1 participants randomized to receive high fat meal first, and low fat meal second
Arm Title
High Fat Meal Second
Arm Type
Experimental
Arm Description
Arm 2 participants randomized to receive low fat meal first, and high fat meal second
Intervention Type
Other
Intervention Name(s)
High fat meal
Intervention Description
60% fat meal
Intervention Type
Other
Intervention Name(s)
Low fat meal
Intervention Description
20% fat meal
Primary Outcome Measure Information:
Title
Overnight Respiratory Exchange Ratio
Description
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 Outcome Measure Information:
Title
Sleep Respiratory Exchange Ratio
Description
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
Title
Peak Increase in Respiratory Exchange Ratio
Description
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
Title
Peak Decrease in Respiratory Exchange Ratio
Description
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.
Time Frame
12 h
Title
Time to Peak Respiratory Exchange Ratio
Description
Average time from meal to peak respiratory exchange ratio value This measurement indicates how long on average it took form the onset of the meal, 6pm, for the participants to achieve their highest/peak respiratory exchange ratio value.
Time Frame
12 h
Title
Time to Nadir Respiratory Exchange Ratio
Description
Average time from meal to nadir respiratory exchange ratio value This measurement indicates how long on average it took form the onset of the meal, 6pm, for the participants to achieve their lowest/nadir respiratory exchange ratio value.
Time Frame
12 h
Title
Slope of Respiratory Exchange Ratio
Description
This value indicates the speed and magnitude of the participants change in respiratory exchange ratio between the peak and nadir values. A more negative value in this measurement indicates either a short time interval between the highest and lowest respiratory exchange ratio values measured and/or a large difference between the highest and lowest values of respiratory exchange ratio values measured.
Time Frame
12 h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808-4124
Country
United States

12. IPD Sharing Statement

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Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber

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