Energy Expenditure and Substrate Oxidation in a Whole Room Calorimeter

USDA, Western Human Nutrition Research Center

Status: Terminated

Conditions: Overweight; Obesity; Body Weight

Treatments: Other: High fat liquid meal; Other: Moderate fat meal; Other: High fat meal; Other: Low fat meal

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04061369

FL106

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

7 participants in 4 patient groups

Meal 1

Experimental group

Description:

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

Treatment:

Other: Low fat meal

Meal 2

Experimental group

Description:

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

Treatment:

Other: Moderate fat meal

Meal 3

Experimental group

Description:

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

Treatment:

Other: High fat meal

Meal 4

Experimental group

Description:

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

Treatment:

Other: High fat liquid meal