Energy Expenditure and Substrate Oxidation in a Whole Room Calorimeter

NCT ID: NCT04061369

Last Updated: 2023-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-18

Study Completion Date

2019-08-31

Brief Summary

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The investigators aim to establish a protocol for metabolic rate measurements obtained using continuous monitoring of oxygen consumption and carbon dioxide production in a whole room calorimeter setting.

Detailed Description

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The purpose of this study is to determine the duration and time course of the thermic effect of single meals consumed by subjects who have been previously fasting for 12 hours overnight. Capturing the full thermic effect of a meal may take up to 8 hours, depending on the calorie load, nutrient composition of the meal, and rate of digestion. The investigators will test meals consisting of conventional foods that are low (20% of energy), moderate (40% of energy) or high (60% of energy) in fat calories, as fat is thought to slow the digestive process. The investigators will test a liquid meal, that is high (60% of energy) in fat calories, as liquid foods are thought to move more quickly through the digestive process. Another purpose of this study is to determine the test-retest reproducibility for the meals described above. To accomplish reproducibility, a volunteer will be permitted to repeat a test day two times using the same test meal.

Conditions

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Overweight Obesity Body Weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will be a randomized design that includes a volunteer receiving one of four test meals.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors
Both the investigator and the participant will be aware of the group assignment. The persons handling the data and statistics will not be aware of the group assignment.

Study Groups

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Meal 1

Meal consisting of conventional foods that is low (20% of energy) in fat calories.

Group Type EXPERIMENTAL

Low fat meal

Intervention Type OTHER

Meal consisting of conventional foods that is low (20% of energy) in fat calories.

Meal 2

Meal consisting of conventional foods that is moderate (40% of energy) in fat calories.

Group Type EXPERIMENTAL

Moderate fat meal

Intervention Type OTHER

Meal consisting of conventional foods that is moderate (40% of energy) in fat calories.

Meal 3

Meal consisting of conventional foods that is high (60% of energy) in fat calories.

Group Type EXPERIMENTAL

High fat meal

Intervention Type OTHER

Meal consisting of conventional foods that is high (60% of energy) in fat calories.

Meal 4

A liquid meal, similar to a "smoothie", that is high (60% of energy) in fat calories.

Group Type EXPERIMENTAL

High fat liquid meal

Intervention Type OTHER

Liquid meal that is high (60% of energy) in fat calories.

Interventions

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Low fat meal

Meal consisting of conventional foods that is low (20% of energy) in fat calories.

Intervention Type OTHER

Moderate fat meal

Meal consisting of conventional foods that is moderate (40% of energy) in fat calories.

Intervention Type OTHER

High fat meal

Meal consisting of conventional foods that is high (60% of energy) in fat calories.

Intervention Type OTHER

High fat liquid meal

Liquid meal that is high (60% of energy) in fat calories.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Body Mass Index 18.5 - 39.9 kg/m2

Exclusion Criteria

* BMI \< 18.5 or \> 40 kg/m2
* Presence of untreated or uncontrolled metabolic diseases
* Presence of gastrointestinal distress or disorders that prevent consumption of a study meal (in particular, the high fat meals)
* Presence of Crohn's disease, irritable bowel syndrome, or colitis
* Previous gallbladder removal
* Presence of cancer or other serious chronic disease
* Implanted medical device that is battery operated, such as a pacemaker, defibrillator, electrocardiograph, or nerve simulator
* Presence of a large amount of metal in the body such as a hip implant
* Current use of tobacco in any form
* Claustrophobia
* Dietary restrictions that would interfere with consuming study meals
* Pregnant or nursing within the last 6 months, or plan to become pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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USDA, Western Human Nutrition Research Center

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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USDA, ARS, Western Human Nutrition Research Center

Davis, California, United States

Site Status

Countries

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United States

Other Identifiers

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FL106

Identifier Type: -

Identifier Source: org_study_id

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