The Effects of Increasing Caloric Intake on Diet-Induced Thermogenesis and 24h Energy Expenditure

Summary

Background:

Diet-induced thermogenesis (DIT) is the amount of energy one s body uses to eat food, absorb the nutrients from the food, and process those nutrients. Researchers would like to understand more about how changing the balances of protein, fat, carbohydrates, and total calories in the diet can affect DIT.

Objective:

To learn how different diets can change a person s DIT.

Eligibility:

Healthy people aged 18 to 60 years who have not intentionally lost weight in the past 6 months.

Design:

Participants will stay in a clinic for about 35 days. They will eat only the food provided. They will receive 8 different diets during the study, including 7 test diets.

Participants will undergo multiple tests.

They will be screened with blood and urine tests and a test of their heart function.

During the first few days:

Their waist, thigh, and neck circumference will be measured.

They will have a DXA scan: They will lie on a padded table for about 20 minutes while an instrument measures the amount of fat in their body.

They will be tested for diabetes.

They will answer questionnaires about topics including eating behavior, hunger, and stress.

Throughout the study:

Their weight will be measured daily.

Blood tests will be repeated.

They will stay in a metabolic chamber a total of 9 times. They will remain in a closed room for 24 hours while researchers monitor the room temperature and levels of oxygen and carbon dioxide. Participants will collect all their urine for each 24-hour period.

...

Conditions

• Obesity
• Normal Physiology
• Healthy Volunteers

Interventions

DIETARY_SUPPLEMENT

+150% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat

+150% of energy balance requirements with standard macronutrient balance of 50% of calories from carbohydrates, 20% from protein, and 30% from fat

DIETARY_SUPPLEMENT

+200% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein

+200% of energy balance requirements with low protein macronutrient balance of 51% of the calories from carbohydrates, 46%, from fat and 3% from protein.

DIETARY_SUPPLEMENT

-25% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat

-25% of energy balance (EB) requirements with standard macronutrient balance of 50% of calories from carbohydrates, 20% from protein, and 30% from fat

DIETARY_SUPPLEMENT

+150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein

+150% of energy balance requirements with low protein macronutrient balance of 51% of the calories from carbohydrates, 46%, from fat and 3% from protein.

DIETARY_SUPPLEMENT

+200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat

+200% of energy balance requirements with standard macronutrient balance of 50% of calories from carbohydrates, 20% from protein, and 30% from fat

DIETARY_SUPPLEMENT

fasting

Fasting for at least 24 hours

DIETARY_SUPPLEMENT

-50% of energy balance requirements. 50% of calories from carbohydrates, 20% from protein, and 30% from fat

-50% of energy balance requirements with standard macronutrient balance of 50% of calories from carbohydrates, 20% from protein, and 30% from fat

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  lead NIH

Principal Investigators

• Tomas Cabeza De Baca, Ph.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-06-06

Primary Completion

2027-02-02

Completion

2027-02-02

Countries

• United States

Study Locations