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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ID
NCT05545306
Status
Recruiting
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Conditions

  • Healthy Volunteers
  • Normal Physiology
  • Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • +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.

Study Details

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. ...

Key Dates

Start date
Jun 6, 2023
Status verified
Jun 2026
Primary completion
Feb 2, 2027
Completion
Feb 2, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Set 1
    +150% LPF +150% SOF -50% +200% LPF +200% SOF Fasting -25%
  • Active Comparator: Set 10
    +200% LPF -25% Fasting +200% SOF -50% +150% LPF +150% SOF
  • Active Comparator: Set 2
    +150% LPF +200% LPF -50% +150% SOF Fasting -25% +200% SOF
  • Active Comparator: Set 3
    +150% LPF Fasting +150% SOF -25% +200% SOF +200% LPF -50%
  • Active Comparator: Set 4
    Fasting -25% +200% LPF -50% +200% SOF +150% SOF +150% LPF
  • Active Comparator: Set 5
    -25% +150% SOF +200% LPF +150% LPF Fasting +200% SOF -50%
  • Active Comparator: Set 6
    Fasting +200% LPF +200% SOF -50% +150% LPF -25% +150% SOF
  • Active Comparator: Set 7
    -50% +200% SOF -25% +150% SOF Fasting +200% LPF +150% LPF
  • Active Comparator: Set 8
    -50% +150% SOF +200% SOF +150% LPF -25% +200% LPF Fasting
  • Active Comparator: Set 9
    +150% SOF -25% +150% LPF +200% SOF Fasting +200% LPF -50%

Primary Outcome Measure

Diet Induced Thermogenesis [ Time Frame: 35 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NIDDK, PhoenixPhoenixArizona85004
Office of Participant Recruitment-NIDDK
[email protected]
602-200-5315

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NIDDK, Phoenix· Phoenix, AZ

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