Clinical trial NCT04061369: 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
Overall status: TERMINATED
Phase: NA
Conditions: Overweight
Obesity
Body Weight
Keywords: thermic effect of feeding
thermogenesis
calorimeter
fuel utilization
Lead sponsor: USDA, Western Human Nutrition Research Center
Sponsor class: FED
First posted: 2019-08-19
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be a randomized design that includes a volunteer receiving one of four test meals.
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Baseline level and change in rate of oxygen consumption
timeFrame: Measured continuously from baseline up to 600 minutes post-meal
measure: Baseline level and change in rate of carbon dioxide production
timeFrame: Measured continuously from baseline up to 600 minutes post-meal
measure: Baseline level and change in respiratory exchange ratio (RER)
timeFrame: Measured continuously from baseline up to 600 minutes post-meal
measure: Baseline level and change in urinary nitrogen excretion
timeFrame: Measured from discrete specimens and a pooled urine sample collected up to 600 minutes post-meal while in the room calorimeter
Secondary outcomes:
measure: Body weight
timeFrame: Baseline
measure: Body fat
timeFrame: Baseline
measure: Lean body mass
timeFrame: Baseline
measure: Total body water
timeFrame: Baseline
measure: Waist circumference
timeFrame: Baseline
measure: Hip circumference
timeFrame: Baseline
measure: Blood pressure
timeFrame: Baseline
measure: Heart rate
timeFrame: Baseline
measure: Body temperature
timeFrame: Baseline
measure: General health and well-being
timeFrame: Baseline
measure: Usual physical activity
timeFrame: Baseline
measure: Baseline level and change in satiety
timeFrame: Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal
measure: Baseline level and change in hunger
timeFrame: Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal
measure: Baseline level and change in desire to eat
timeFrame: Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal
measure: Baseline level and change in prospective consumption
timeFrame: Baseline, and 5, 10, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 minutes after meal
measure: Baseline level and change in energy expenditure
timeFrame: Expressed from baseline up to 600 minutes post-meal
measure: Baseline level and change in carbohydrate combustion
timeFrame: Expressed from baseline up to 600 minutes post-meal
measure: Baseline level and change in fat combustion
timeFrame: Expressed from baseline up to 600 minutes post-meal
measure: Baseline level and change in thermic effect of food (TEF)
timeFrame: Expressed from baseline up to 600 minutes post-meal
measure: Baseline level and change in heart rate
timeFrame: Expressed from baseline up to 600 minutes post-meal
Other outcomes:
Locations:
city: Davis
country: United States
facility: USDA, ARS, Western Human Nutrition Research Center
state: California
Study officials:
References: