Energy Expenditure and Substrate Oxidation in a Whole Room Calorimeter

NCT04061369 | Terminated

• 1 other identifier: FL106
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity; Body Weight

Keywords

thermic effect of feeding; thermogenesis; calorimeter; fuel utilization

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (20)

• Body weight

  Baseline

• Body fat

  Baseline

• Lean body mass

  Baseline

• Total body water

  Baseline

• Waist circumference

  Baseline

Study Arms (4)

Meal 1

EXPERIMENTAL

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

Other: Low fat meal

Meal 2

EXPERIMENTAL

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

Other: Moderate fat meal

Meal 3

EXPERIMENTAL

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

Other: High fat meal

Meal 4

EXPERIMENTAL

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

Other: High fat liquid meal

Interventions

Low fat meal OTHER

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

Meal 1

Moderate fat meal OTHER

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

Meal 2

High fat meal OTHER

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

Meal 3

High fat liquid meal OTHER

Liquid meal that is high (60% of energy) in fat calories.

Meal 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body Mass Index 18.5 - 39.9 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• USDA, Western Human Nutrition Research Center: lead

Study Sites (1)

USDA, ARS, Western Human Nutrition Research Center

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Body Weight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: August 19, 2019
• Study Start: April 18, 2019
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: May 15, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)