Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-14

Study Completion Date

2020-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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High Fat Meal First

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

Group Type EXPERIMENTAL

High fat meal

Intervention Type OTHER

60% fat meal

Low fat meal

Intervention Type OTHER

20% fat meal

High Fat Meal Second

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

Group Type EXPERIMENTAL

High fat meal

Intervention Type OTHER

60% fat meal

Low fat meal

Intervention Type OTHER

20% fat meal

Interventions

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High fat meal

60% fat meal

Intervention Type OTHER

Low fat meal

20% fat meal

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes