Energy Expenditure and Substrate Oxidation in a Whole Room Calorimeter

Sponsor

USDA, Western Human Nutrition Research Center (U.S. Fed)

Overall Status

Recruiting

CT.gov ID

NCT04061369

Collaborator

(none)

Enrollment

Location

Arms

53.4

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight Obesity Body Weight	Other: Low fat meal Other: Moderate fat meal Other: High fat meal Other: High fat liquid meal	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (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.

Primary Purpose:

Basic Science

Official Title:

Establishing Short-term Protocols for Measuring Resting and Postprandial Energy Expenditure and Substrate Oxidation in a Whole Room Calorimeter

Actual Study Start Date :

Apr 18, 2019

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Meal 1 Meal consisting of conventional foods that is low (20% of energy) in fat calories.	Other: Low fat meal Meal consisting of conventional foods that is low (20% of energy) in fat calories.
Experimental: Meal 2 Meal consisting of conventional foods that is moderate (40% of energy) in fat calories.	Other: Moderate fat meal Meal consisting of conventional foods that is moderate (40% of energy) in fat calories.
Experimental: Meal 3 Meal consisting of conventional foods that is high (60% of energy) in fat calories.	Other: High fat meal Meal consisting of conventional foods that is high (60% of energy) in fat calories.
Experimental: Meal 4 A liquid meal, similar to a "smoothie", that is high (60% of energy) in fat calories.	Other: High fat liquid meal Liquid meal that is high (60% of energy) in fat calories.

Outcome Measures

Primary Outcome Measures

Baseline level and change in rate of oxygen consumption [Measured continuously from baseline up to 600 minutes post-meal]
Oxygen consumption rate (VO2/min) measured by gas analyzer while inside whole room calorimeter
Baseline level and change in rate of carbon dioxide production [Measured continuously from baseline up to 600 minutes post-meal]
Carbon dioxide production rate (VCO2/min) measured by gas analyzer while inside whole room calorimeter
Baseline level and change in respiratory exchange ratio (RER) [Measured continuously from baseline up to 600 minutes post-meal]
RER is expressed as the ratio of VCO2 to VO2
Baseline level and change in urinary nitrogen excretion [Measured from discrete specimens and a pooled urine sample collected up to 600 minutes post-meal while in the room calorimeter]
Urinary nitrogen measured via combustion and gas analysis in mg

Secondary Outcome Measures

Body weight [Baseline]
measured in kg
Body fat [Baseline]
Measured in kg using multi frequency bioimpedance
Lean body mass [Baseline]
Measured in kg using multi frequency bioimpedance
Total body water [Baseline]
Measured in kg using multi frequency bioimpedance
Waist circumference [Baseline]
measured in cm
Hip circumference [Baseline]
measured in cm
Blood pressure [Baseline]
Both systolic and diastolic pressure measured in mmHg using automated instrument
Heart rate [Baseline]
measured in beats per minute using automated instrument
Body temperature [Baseline]
measured in centigrade
General health and well-being [Baseline]
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 [Baseline]
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 [Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal]
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 [Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal]
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 [Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal]
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 [Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal]
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 [Expressed from baseline up to 600 minutes post-meal]
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 [Expressed from baseline up to 600 minutes post-meal]
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 [Expressed from baseline up to 600 minutes post-meal]
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) [Expressed from baseline up to 600 minutes post-meal]
Calculated as the increase in post-meal energy expenditure above baseline energy expenditure
Baseline level and change in heart rate [Expressed from baseline up to 600 minutes post-meal]
Heart rate is estimated from wrist-worn activity monitor

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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