Energy Expenditure and Substrate Oxidation in a Whole Room Calorimeter

Not Applicable

Terminated

• Conditions: Obesity; Overweight; Body Weight
• Interventions: Other: Moderate fat meal; Other: Low fat meal; Other: High fat meal; Other: High fat liquid meal

• Registration Number: NCT04061369
• Lead Sponsor: USDA, Western Human Nutrition Research Center

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.

Study Timeline

• Study Start: 2019-04-18
• Study First Submitted: 2019-07-22
• Study First Submitted QC: 2019-08-16
• Study First Posted: 2019-08-19
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Status Verified: 2022-08
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 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 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 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

Name	Time	Method
Body weight	Baseline	measured in kg
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 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 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
Body fat	Baseline	Measured in kg using multi frequency bioimpedance
Lean body mass	Baseline	Measured in kg using multi frequency bioimpedance
Hip circumference	Baseline	measured in cm
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 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 heart rate	Expressed from baseline up to 600 minutes post-meal	Heart rate is estimated from wrist-worn activity monitor
Total body water	Baseline	Measured in kg using multi frequency bioimpedance
Waist circumference	Baseline	measured in cm
Blood pressure	Baseline	Both systolic and diastolic pressure measured in mmHg using automated instrument
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.
Heart rate	Baseline	measured in beats per minute using automated instrument
Body temperature	Baseline	measured in centigrade
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 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)
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 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)

Trial Locations

Locations (1)

USDA, ARS, Western Human Nutrition Research Center; 🇺🇸 Davis, California, United States