Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT05545306

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

Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-05-12

120

Participants Needed

1

Research Sites

191 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, aged 18-60 years old
  • No episodes of intentional weight loss over previous 6 months
Not Eligible

You will not qualify if you...

  • Current use of tobacco products with moderate or higher dependence (Fagerstrom score > 2)
  • Diabetes diagnosis or fasting glucose ≥ 126 mg/dl or HbA1c ≥ 6.5%
  • History of type 1 or type 2 diabetes
  • Endocrine disorders including Cushing's disease, pituitary disorders, hypo- or hyperthyroidism
  • TSH levels <0.1 or ≥ 10 uIU/mL
  • Pulmonary disorders limiting protocol adherence
  • Cardiovascular diseases including coronary heart disease, heart failure, arrhythmias, peripheral artery disease
  • Hypertension diagnosis or treatment or blood pressure >140/90 mmHg
  • Liver disease including cirrhosis, active hepatitis B or C, or elevated liver enzymes
  • Renal disease with serum creatinine ≥ 1.5 mg/dl or eGFR <60 mL/min/1.73m2
  • Central nervous system disease including stroke, dementia, neurodegenerative disorders
  • Cancer requiring treatment in past 5 years except certain cured cancers
  • Infectious diseases including active tuberculosis, HIV, chronic infections
  • Alcohol abuse (AUDIT score ≥ 8)
  • Current use of illegal drugs except marijuana
  • Female pregnancy, lactation, or peri- or post-menopause
  • Weight ≥ 450 lb (DXA scanner limit)
  • Inability to read or speak English
  • Inability to provide informed consent
  • Psychological conditions incompatible with participation
  • Use of medications or supplements altering energy metabolism
  • Inability to consume ≥95% of provided diets

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

NIDDK, Phoenix

Phoenix, Arizona, United States, 85004

Actively Recruiting

Loading map...

Research Team

O

Office of Participant Recruitment (NIDDK

CONTACT

T

Tomas Cabeza De Baca, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

10

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here