Health TrialsbyHealthPanel

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

ConditionsObesityNormal PhysiologyHealthy Volunteers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

About this trial

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.

...

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or female, aged 18-60 years old

No episodes of intentional weight loss over previous 6 months

Disqualifiers

Current use of tobacco products that exceed "Very Low Dependence" on the Fagerstrom Test for Nicotine Dependence Tool (score greater than 2)

Diabetes

Pulmonary disorders

Cardiovascular diseases,

Trial design

Design model

Crossover

Treatments tested in this trial

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

    Dietary supplement

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

  • fasting

    Dietary supplement

    Fasting for at least 24 hours

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

    Dietary supplement

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

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

    Dietary supplement

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

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

    Dietary supplement

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

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

    Dietary supplement

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

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

    Dietary supplement

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

Treatment groups

120 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: Set 1Active comparator 7 interventions
Group B: Set 10Active comparator 7 interventions
Group C: Set 2Active comparator 7 interventions
Group D: Set 3Active comparator 7 interventions
Group E: Set 4Active comparator 7 interventions
Group F: Set 5Active comparator 7 interventions
Group G: Set 6Active comparator 7 interventions
Group H: Set 7Active comparator 7 interventions
Group I: Set 8Active comparator 7 interventions
Group J: Set 9Active comparator 7 interventions

Trial outcomes

Primary outcomes

1

Diet Induced Thermogenesis

DIT is calculated from 24h EE during feeding-24h EE during fasting under different caloric loads

Time frame
35 days

Secondary outcomes

1

FGF 21

assessment of appetitive hormones before and after 24h in a whole room calorimeter with each intervention

Time frame
35 days
2

24 hour energy expenditure (24h EE)

24h EE is measured in a whole room calorimeter

Time frame
35 days
3

Substrate Oxidation

24h respiratory quotient measured in a whole room calorimeter

Time frame
35 days
4

Psychosocial Assessment

assessment of psychosocial state through assessment of food insecurity and perceived stress

Time frame
35 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov
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