NCT05545306

Brief 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. ...

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
8mo left

Started Jun 2023

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jun 2023Feb 2027

First Submitted

Initial submission to the registry

September 16, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

June 6, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2027

Last Updated

June 11, 2026

Status Verified

June 9, 2026

Enrollment Period

3.7 years

First QC Date

September 16, 2022

Last Update Submit

June 10, 2026

Conditions

ObesityNormal PhysiologyHealthy Volunteers

Keywords

Weight GainEnergy ExpenditureLow Protein OverfeedingFastingNatural History

Outcome Measures

Primary Outcomes (1)

  • Diet Induced Thermogenesis

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

    35 days

Secondary Outcomes (6)

  • FGF 21

    35 days

  • 24 hour energy expenditure (24h EE)

    35 days

  • Substrate Oxidation

    35 days

  • Psychosocial Assessment

    35 days

  • Ghrelin

    35 days

  • +1 more secondary outcomes

Study Arms (10)

Set 1

ACTIVE COMPARATOR

+150% LPF +150% SOF -50% +200% LPF +200% SOF Fasting -25%

Dietary Supplement: +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: fastingDietary Supplement: -50% of energy balance requirements. 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +150% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +200% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from proteinDietary Supplement: -25% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein

Set 10

ACTIVE COMPARATOR

+200% LPF -25% Fasting +200% SOF -50% +150% LPF +150% SOF

Dietary Supplement: +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: fastingDietary Supplement: -50% of energy balance requirements. 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +150% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +200% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from proteinDietary Supplement: -25% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein

Set 2

ACTIVE COMPARATOR

+150% LPF +200% LPF -50% +150% SOF Fasting -25% +200% SOF

Dietary Supplement: +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: fastingDietary Supplement: -50% of energy balance requirements. 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +150% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +200% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from proteinDietary Supplement: -25% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein

Set 3

ACTIVE COMPARATOR

+150% LPF Fasting +150% SOF -25% +200% SOF +200% LPF -50%

Dietary Supplement: +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: fastingDietary Supplement: -50% of energy balance requirements. 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +150% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +200% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from proteinDietary Supplement: -25% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein

Set 4

ACTIVE COMPARATOR

Fasting -25% +200% LPF -50% +200% SOF +150% SOF +150% LPF

Dietary Supplement: +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: fastingDietary Supplement: -50% of energy balance requirements. 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +150% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +200% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from proteinDietary Supplement: -25% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein

Set 5

ACTIVE COMPARATOR

-25% +150% SOF +200% LPF +150% LPF Fasting +200% SOF -50%

Dietary Supplement: +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: fastingDietary Supplement: -50% of energy balance requirements. 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +150% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +200% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from proteinDietary Supplement: -25% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein

Set 6

ACTIVE COMPARATOR

Fasting +200% LPF +200% SOF -50% +150% LPF -25% +150% SOF

Dietary Supplement: +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: fastingDietary Supplement: -50% of energy balance requirements. 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +150% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +200% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from proteinDietary Supplement: -25% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein

Set 7

ACTIVE COMPARATOR

-50% +200% SOF -25% +150% SOF Fasting +200% LPF +150% LPF

Dietary Supplement: +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: fastingDietary Supplement: -50% of energy balance requirements. 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +150% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +200% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from proteinDietary Supplement: -25% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein

Set 8

ACTIVE COMPARATOR

-50% +150% SOF +200% SOF +150% LPF -25% +200% LPF Fasting

Dietary Supplement: +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: fastingDietary Supplement: -50% of energy balance requirements. 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +150% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +200% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from proteinDietary Supplement: -25% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein

Set 9

ACTIVE COMPARATOR

+150% SOF -25% +150% LPF +200% SOF Fasting +200% LPF -50%

Dietary Supplement: +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: fastingDietary Supplement: -50% of energy balance requirements. 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +150% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +200% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from proteinDietary Supplement: -25% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDietary Supplement: +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein

Interventions

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

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

Set 1Set 10Set 2Set 3Set 4Set 5Set 6Set 7Set 8Set 9
+150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from proteinDIETARY_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.

Set 1Set 10Set 2Set 3Set 4Set 5Set 6Set 7Set 8Set 9
fastingDIETARY_SUPPLEMENT

Fasting for at least 24 hours

Set 1Set 10Set 2Set 3Set 4Set 5Set 6Set 7Set 8Set 9
+200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDIETARY_SUPPLEMENT

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

Set 1Set 10Set 2Set 3Set 4Set 5Set 6Set 7Set 8Set 9
-50% of energy balance requirements. 50% of calories from carbohydrates, 20% from protein, and 30% from fatDIETARY_SUPPLEMENT

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

Set 1Set 10Set 2Set 3Set 4Set 5Set 6Set 7Set 8Set 9
+150% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fatDIETARY_SUPPLEMENT

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

Set 1Set 10Set 2Set 3Set 4Set 5Set 6Set 7Set 8Set 9
+200% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from proteinDIETARY_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.

Set 1Set 10Set 2Set 3Set 4Set 5Set 6Set 7Set 8Set 9

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • Diabetes
  • i. Fasting glucose \>= 126 mg/dl or hba1c \>= 6.5% or
  • ii. history of type 1 or type 2 diabetes
  • Endocrine disorders, such as
  • i. History of Cushing s disease, pituitary disorders, or hypo- and hyperthyroidism
  • ii. TSH \<0.1 or \>= 10 uIU/mL
  • Pulmonary disorders
  • i. History of chronic obstructive pulmonary disease or other lung disease that which would limit ability to follow the protocol (investigator judgment)
  • Cardiovascular diseases,
  • i. Including history of coronary heart disease, heart failure, arrhythmias, and peripheral artery disease
  • Hypertension,
  • i. History of diagnosis and current treatment by an outside clinician
  • ii. or sitting blood pressure measurement, using an appropriate cuff, higher than
  • +24 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIDDK, Phoenix

Phoenix, Arizona, 85004, United States

RECRUITING

Related Publications (2)

  • Hollstein T, Ando T, Basolo A, Krakoff J, Votruba SB, Piaggi P. Metabolic response to fasting predicts weight gain during low-protein overfeeding in lean men: further evidence for spendthrift and thrifty metabolic phenotypes. Am J Clin Nutr. 2019 Sep 1;110(3):593-604. doi: 10.1093/ajcn/nqz062.

    PMID: 31172178BACKGROUND

  • Li XY. [Clinical diagnosis of pulmonary solitary lesions: a correlative clinico-pathological review of 232 cases (author's transl)]. Zhonghua Jie He He Hu Xi Xi Ji Bing Za Zhi. 1981 Oct;4(5):285-7. No abstract available. Chinese.

    PMID: 7341172BACKGROUND

Related Links

MeSH Terms

Conditions

ObesityWeight GainFasting

Interventions

Nutritional RequirementsAngptl4 protein, mouse

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Tomas Cabeza De Baca, Ph.D.

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Office of Participant Recruitment (NIDDK

CONTACT

(602) 200-5315niddkphxcontact@mail.nih.gov

Tomas Cabeza De Baca, Ph.D.

CONTACT

(301) 496-9404tommy.cabezadebaca@nih.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2022

First Posted

September 19, 2022

Study Start

June 6, 2023

Primary Completion (Estimated)

February 2, 2027

Study Completion (Estimated)

February 2, 2027

Last Updated

June 11, 2026

Record last verified: 2026-06-09

Locations

US(1)