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Energy Expenditure and Substrate Oxidation in a Whole Room Calorimeter

Primary Purpose

Overweight, Obesity, Body Weight

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low fat meal
Moderate fat meal
High fat meal
High fat liquid meal
Sponsored by
USDA, Western Human Nutrition Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight focused on measuring thermic effect of feeding, thermogenesis, calorimeter, fuel utilization

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • USDA, ARS, Western Human Nutrition Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Meal 1

Meal 2

Meal 3

Meal 4

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Baseline level and change in rate of oxygen consumption
Oxygen consumption rate (VO2/min) measured by gas analyzer while inside whole room calorimeter
Baseline level and change in rate of carbon dioxide production
Carbon dioxide production rate (VCO2/min) measured by gas analyzer while inside whole room calorimeter
Baseline level and change in respiratory exchange ratio (RER)
RER is expressed as the ratio of VCO2 to VO2
Baseline level and change in urinary nitrogen excretion
Urinary nitrogen measured via combustion and gas analysis in mg

Secondary Outcome Measures

Body weight
measured in kg
Body fat
Measured in kg using multi frequency bioimpedance
Lean body mass
Measured in kg using multi frequency bioimpedance
Total body water
Measured in kg using multi frequency bioimpedance
Waist circumference
measured in cm
Hip circumference
measured in cm
Blood pressure
Both systolic and diastolic pressure measured in mmHg using automated instrument
Heart rate
measured in beats per minute using automated instrument
Body temperature
measured in centigrade
General health and well-being
The SF-36 Short form general health and well-being questionnaire measured once. The survey has eight scales; physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general health. All 36 items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Items in the same scale are averaged together to create the 8 scale scores.
Usual physical activity
Physical activity estimated from the Stanford Brief Physical Activity questionnaire. Scale is categorical for two subscales: work physical activity and leisure time activity.
Baseline level and change in satiety
Self-reported feelings of fullness measured on a visual analog scale. Responses will be a marked on an unsegmented line from 0 or "not at all" to 100 or "extremely."
Baseline level and change in hunger
Self-reported feelings of hunger measured on a visual analog scale. Responses will be a marked on an unsegmented line from 0 or "not at all" to 100 or "extremely."
Baseline level and change in desire to eat
Self-reported feelings of the desire to eat measured on a visual analog scale. Responses will be a marked on an unsegmented line from 0 or "not at all" to 100 or "extremely."
Baseline level and change in prospective consumption
Self-reported feelings of prospective consumption measured on a visual analog scale. Responses will be a marked on an unsegmented line from 0 or "not at all" to 100 or "extremely."
Baseline level and change in energy expenditure
Calculated as kcal/min from oxygen consumption and carbon dioxide production (L/min) and urinary nitrogen excretion (g/min)
Baseline level and change in carbohydrate combustion
Calculated as g/min from oxygen consumption and carbon dioxide production (L/min) and urinary nitrogen excretion (g/min)
Baseline level and change in fat combustion
Calculated as g/min from oxygen consumption and carbon dioxide production (L/min) and urinary nitrogen excretion (g/min)
Baseline level and change in thermic effect of food (TEF)
Calculated as the increase in post-meal energy expenditure above baseline energy expenditure
Baseline level and change in heart rate
Heart rate is estimated from wrist-worn activity monitor

Full Information

First Posted
July 22, 2019
Last Updated
May 11, 2023
Sponsor
USDA, Western Human Nutrition Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT04061369
Brief Title
Energy Expenditure and Substrate Oxidation in a Whole Room Calorimeter
Official Title
Establishing Short-term Protocols for Measuring Resting and Postprandial Energy Expenditure and Substrate Oxidation in a Whole Room Calorimeter
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
After Covid-19 pandemic, room calorimeter not functional
Study Start Date
April 18, 2019 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA, Western Human Nutrition 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 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Body Weight
Keywords
thermic effect of feeding, thermogenesis, calorimeter, fuel utilization

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will be a randomized design that includes a volunteer receiving one of four test meals.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meal 1
Arm Type
Experimental
Arm Description
Meal consisting of conventional foods that is low (20% of energy) in fat calories.
Arm Title
Meal 2
Arm Type
Experimental
Arm Description
Meal consisting of conventional foods that is moderate (40% of energy) in fat calories.
Arm Title
Meal 3
Arm Type
Experimental
Arm Description
Meal consisting of conventional foods that is high (60% of energy) in fat calories.
Arm Title
Meal 4
Arm Type
Experimental
Arm Description
A liquid meal, similar to a "smoothie", that is high (60% of energy) in fat calories.
Intervention Type
Other
Intervention Name(s)
Low fat meal
Intervention Description
Meal consisting of conventional foods that is low (20% of energy) in fat calories.
Intervention Type
Other
Intervention Name(s)
Moderate fat meal
Intervention Description
Meal consisting of conventional foods that is moderate (40% of energy) in fat calories.
Intervention Type
Other
Intervention Name(s)
High fat meal
Intervention Description
Meal consisting of conventional foods that is high (60% of energy) in fat calories.
Intervention Type
Other
Intervention Name(s)
High fat liquid meal
Intervention Description
Liquid meal that is high (60% of energy) in fat calories.
Primary Outcome Measure Information:
Title
Baseline level and change in rate of oxygen consumption
Description
Oxygen consumption rate (VO2/min) measured by gas analyzer while inside whole room calorimeter
Time Frame
Measured continuously from baseline up to 600 minutes post-meal
Title
Baseline level and change in rate of carbon dioxide production
Description
Carbon dioxide production rate (VCO2/min) measured by gas analyzer while inside whole room calorimeter
Time Frame
Measured continuously from baseline up to 600 minutes post-meal
Title
Baseline level and change in respiratory exchange ratio (RER)
Description
RER is expressed as the ratio of VCO2 to VO2
Time Frame
Measured continuously from baseline up to 600 minutes post-meal
Title
Baseline level and change in urinary nitrogen excretion
Description
Urinary nitrogen measured via combustion and gas analysis in mg
Time Frame
Measured from discrete specimens and a pooled urine sample collected up to 600 minutes post-meal while in the room calorimeter
Secondary Outcome Measure Information:
Title
Body weight
Description
measured in kg
Time Frame
Baseline
Title
Body fat
Description
Measured in kg using multi frequency bioimpedance
Time Frame
Baseline
Title
Lean body mass
Description
Measured in kg using multi frequency bioimpedance
Time Frame
Baseline
Title
Total body water
Description
Measured in kg using multi frequency bioimpedance
Time Frame
Baseline
Title
Waist circumference
Description
measured in cm
Time Frame
Baseline
Title
Hip circumference
Description
measured in cm
Time Frame
Baseline
Title
Blood pressure
Description
Both systolic and diastolic pressure measured in mmHg using automated instrument
Time Frame
Baseline
Title
Heart rate
Description
measured in beats per minute using automated instrument
Time Frame
Baseline
Title
Body temperature
Description
measured in centigrade
Time Frame
Baseline
Title
General health and well-being
Description
The SF-36 Short form general health and well-being questionnaire measured once. The survey has eight scales; physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general health. All 36 items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Items in the same scale are averaged together to create the 8 scale scores.
Time Frame
Baseline
Title
Usual physical activity
Description
Physical activity estimated from the Stanford Brief Physical Activity questionnaire. Scale is categorical for two subscales: work physical activity and leisure time activity.
Time Frame
Baseline
Title
Baseline level and change in satiety
Description
Self-reported feelings of fullness measured on a visual analog scale. Responses will be a marked on an unsegmented line from 0 or "not at all" to 100 or "extremely."
Time Frame
Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal
Title
Baseline level and change in hunger
Description
Self-reported feelings of hunger measured on a visual analog scale. Responses will be a marked on an unsegmented line from 0 or "not at all" to 100 or "extremely."
Time Frame
Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal
Title
Baseline level and change in desire to eat
Description
Self-reported feelings of the desire to eat measured on a visual analog scale. Responses will be a marked on an unsegmented line from 0 or "not at all" to 100 or "extremely."
Time Frame
Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal
Title
Baseline level and change in prospective consumption
Description
Self-reported feelings of prospective consumption measured on a visual analog scale. Responses will be a marked on an unsegmented line from 0 or "not at all" to 100 or "extremely."
Time Frame
Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal
Title
Baseline level and change in energy expenditure
Description
Calculated as kcal/min from oxygen consumption and carbon dioxide production (L/min) and urinary nitrogen excretion (g/min)
Time Frame
Expressed from baseline up to 600 minutes post-meal
Title
Baseline level and change in carbohydrate combustion
Description
Calculated as g/min from oxygen consumption and carbon dioxide production (L/min) and urinary nitrogen excretion (g/min)
Time Frame
Expressed from baseline up to 600 minutes post-meal
Title
Baseline level and change in fat combustion
Description
Calculated as g/min from oxygen consumption and carbon dioxide production (L/min) and urinary nitrogen excretion (g/min)
Time Frame
Expressed from baseline up to 600 minutes post-meal
Title
Baseline level and change in thermic effect of food (TEF)
Description
Calculated as the increase in post-meal energy expenditure above baseline energy expenditure
Time Frame
Expressed from baseline up to 600 minutes post-meal
Title
Baseline level and change in heart rate
Description
Heart rate is estimated from wrist-worn activity monitor
Time Frame
Expressed from baseline up to 600 minutes post-meal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
USDA, ARS, Western Human Nutrition Research Center
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Energy Expenditure and Substrate Oxidation in a Whole Room Calorimeter

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