Taking people in United StatesNo phase

Tests how different diets change energy use after eating in healthy adults

Studies how changing calories and nutrients in the diet affects energy the body uses.

Key facts

Who runs it: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Where: Phoenix, United StatesSee the site
Trial code: NCT05545306
Registry title: The Effects of Increasing Caloric Intake on Diet-Induced Thermogenesis and 24h Energy Expenditure
Status: Recruiting
People taking part: 120 people, planned
Started: 6 Jun 2023
Expected to end: 2 Feb 2027
Type of study: Interventional, 10 groupsOne group gets an existing treatment, for comparison.
Treatments tested: +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat
fasting
-50% of energy balance requirements. 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
+200% of dietary requirements, 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
+150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein
Record updated: 28 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for healthy adults who have not tried to lose weight in the past 6 months. It studies how different diets change the energy the body uses to eat and process food.

Age: 18 to 60 years
Sex: Men and women can join.
Earlier treatment: No intentional weight loss in the past 6 months.

Main reasons for not taking part

Diabetes, or heart, lung, liver, kidney or brain disease
Pregnancy or breastfeeding, or peri- or post-menopause
Current use of illegal drugs (other than marijuana) or signs of alcohol abuse
Medicines or supplements that change energy metabolism
Weight of 450 lb (204 kg). or more

The registry criteria, word for word

Show all 30 criteriaShow less

Who cannot take part

Central nervous system disease:; including history of previous history of cerebrovascular accidents, dementia, and neurodegenerative disorders
Current use of illegal drugs such as amphetamines, cocaine, opiates, or heroin; use of marijuana is permitted
Current use of medications/dietary supplements/alternative therapies known to alter energy metabolism
history of type 1 or type 2 diabetes; -Endocrine disorders, such as
History of Cushing s disease, pituitary disorders, or hypo- and hyperthyroidism
Pulmonary disorders; History of chronic obstructive pulmonary disease or other lung disease that which would limit ability to follow the protocol (investigator judgment)
Cardiovascular diseases,; Including history of coronary heart disease, heart failure, arrhythmias, and peripheral artery disease
Hypertension,; History of diagnosis and current treatment by an outside clinician
or sitting blood pressure measurement, using an appropriate cuff, higher than; 140/90 mmHg; -Liver disease,
including history of cirrhosis, active hepatitis B or C
Cancer:; History requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer)
Infectious disease:; History of active tuberculosis, HIV chronic coccidiomycosis or other chronic infections
Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators
History of psychological conditions including (but not limited to) claustrophobia, clinical depression, bipolar disorders, or forms of mental incapacity that would be incompatible with safe and successful participation in this study
Diabetes; Fasting glucose >= 126 mg/dl or hba1c >= 6.5% or
AST or ALT >=3 times upper limit of normal on screening labs
Renal disease; Serum creatinine >= 1.5 mg/dls
Abnormal kidney function (eGFR <60 mL/min/1.73m\^2)
An individual who meets any of the following criteria will be excluded from participation in this study:
Current use of tobacco products that exceed "Very Low Dependence" on the Fagerstrom Test for Nicotine Dependence Tool (score greater than 2)
TSH <0.1 or >= 10 uIU/mL
Evidence of alcohol abuse as defined by > =8-point score on the Alcohol consumption screening AUDIT questionnaire in adults
For Females:; i. Pregnancy or lactation by history and urine pregnancy test; ii. Peri- or post-menopause by self-report or irregular menstrual cycle
Measured weight: greater than or equal to 450 lb. (maximum weight allowed on the DXA scanning tables by the manufacturer)
Inability to speak or read English by self-report
Inability to provide informed consent
Inability to consume provided diets due to dietary concerns that will not allow them to consume >=95% of provided calories

Other criteria

INCLUSION CRITERIA:; In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Male or female, aged 18-60 years old
No episodes of intentional weight loss over previous 6 months

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 60 years old?

Where in United States

NIDDK, PhoenixPhoenix, United StatesContact: Office of Participant Recruitment-NIDDKTaking people

About the trial

What the trial wants to find out

Background:

Read full original descriptionShow less

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.

...

The 10 groups in the trial

Set 1Existing treatment, for comparison
+150% LPF +150% SOF -50% +200% LPF +200% SOF Fasting -25%
Treatment: +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, fasting, -50% of energy balance requirements. 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, +200% of dietary requirements, 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, and +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein
Set 10Existing treatment, for comparison
+200% LPF -25% Fasting +200% SOF -50% +150% LPF +150% SOF
Treatment: +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, fasting, -50% of energy balance requirements. 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, +200% of dietary requirements, 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, and +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein
Set 2Existing treatment, for comparison
+150% LPF +200% LPF -50% +150% SOF Fasting -25% +200% SOF
Treatment: +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, fasting, -50% of energy balance requirements. 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, +200% of dietary requirements, 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, and +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein
Set 3Existing treatment, for comparison
+150% LPF Fasting +150% SOF -25% +200% SOF +200% LPF -50%
Treatment: +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, fasting, -50% of energy balance requirements. 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, +200% of dietary requirements, 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, and +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein
Set 4Existing treatment, for comparison
Fasting -25% +200% LPF -50% +200% SOF +150% SOF +150% LPF
Treatment: +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, fasting, -50% of energy balance requirements. 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, +200% of dietary requirements, 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, and +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein
Set 5Existing treatment, for comparison
-25% +150% SOF +200% LPF +150% LPF Fasting +200% SOF -50%
Treatment: +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, fasting, -50% of energy balance requirements. 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, +200% of dietary requirements, 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, and +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein
Set 6Existing treatment, for comparison
Fasting +200% LPF +200% SOF -50% +150% LPF -25% +150% SOF
Treatment: +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, fasting, -50% of energy balance requirements. 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, +200% of dietary requirements, 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, and +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein
Set 7Existing treatment, for comparison
-50% +200% SOF -25% +150% SOF Fasting +200% LPF +150% LPF
Treatment: +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, fasting, -50% of energy balance requirements. 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, +200% of dietary requirements, 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, and +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein
Set 8Existing treatment, for comparison
-50% +150% SOF +200% SOF +150% LPF -25% +200% LPF Fasting
Treatment: +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, fasting, -50% of energy balance requirements. 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, +200% of dietary requirements, 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, and +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein
Set 9Existing treatment, for comparison
+150% SOF -25% +150% LPF +200% SOF Fasting +200% LPF -50%
Treatment: +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, fasting, -50% of energy balance requirements. 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, +200% of dietary requirements, 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, and +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein