Energy Expenditure and Substrate Oxidation in a Whole Room Calorimeter

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04061369
• Other study ID #: FL106
• Status: Terminated
• Phase: N/A
• Start date: April 18, 2019
• Est. completion date: August 31, 2019

Study information

• Verified date: August 2022
• Source: USDA, Western Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight

Intervention

Other:
• Low fat meal
Meal consisting of conventional foods that is low (20% of energy) in fat calories.
• Moderate fat meal
Meal consisting of conventional foods that is moderate (40% of energy) in fat calories.
• High fat meal
Meal consisting of conventional foods that is high (60% of energy) in fat calories.
• High fat liquid meal
Liquid meal that is high (60% of energy) in fat calories.

Locations

Country	Name	City	State
United States	USDA, ARS, Western Human Nutrition Research Center	Davis	California

Sponsors (1)

Lead Sponsor	Collaborator
USDA, Western Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline level and change in rate of oxygen consumption	Oxygen consumption rate (VO2/min) measured by gas analyzer while inside whole room calorimeter	Measured continuously from baseline up to 600 minutes post-meal
Primary	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	Measured continuously from baseline up to 600 minutes post-meal
Primary	Baseline level and change in respiratory exchange ratio (RER)	RER is expressed as the ratio of VCO2 to VO2	Measured continuously from baseline up to 600 minutes post-meal
Primary	Baseline level and change in urinary nitrogen excretion	Urinary nitrogen measured via combustion and gas analysis in mg	Measured from discrete specimens and a pooled urine sample collected up to 600 minutes post-meal while in the room calorimeter
Secondary	Body weight	measured in kg	Baseline
Secondary	Body fat	Measured in kg using multi frequency bioimpedance	Baseline
Secondary	Lean body mass	Measured in kg using multi frequency bioimpedance	Baseline
Secondary	Total body water	Measured in kg using multi frequency bioimpedance	Baseline
Secondary	Waist circumference	measured in cm	Baseline
Secondary	Hip circumference	measured in cm	Baseline
Secondary	Blood pressure	Both systolic and diastolic pressure measured in mmHg using automated instrument	Baseline
Secondary	Heart rate	measured in beats per minute using automated instrument	Baseline
Secondary	Body temperature	measured in centigrade	Baseline
Secondary	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.	Baseline
Secondary	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
Secondary	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, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal
Secondary	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, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal
Secondary	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, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal
Secondary	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, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal
Secondary	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)	Expressed from baseline up to 600 minutes post-meal
Secondary	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)	Expressed from baseline up to 600 minutes post-meal
Secondary	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)	Expressed from baseline up to 600 minutes post-meal
Secondary	Baseline level and change in thermic effect of food (TEF)	Calculated as the increase in post-meal energy expenditure above baseline energy expenditure	Expressed from baseline up to 600 minutes post-meal
Secondary	Baseline level and change in heart rate	Heart rate is estimated from wrist-worn activity monitor	Expressed from baseline up to 600 minutes post-meal