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The Effects of Increasing Caloric Intake on Diet-Induced Thermogenesis and 24h Energy Expenditure
NCT05545306 · View on ClinicalTrials.gov ↗
Study 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. ...
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat
- DIETARY_SUPPLEMENT fasting
- DIETARY_SUPPLEMENT -50% of energy balance requirements. 50% of calories from carbohydrates, 20% from protein, and 30% from fat
- DIETARY_SUPPLEMENT +150% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat
- DIETARY_SUPPLEMENT +200% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein
Study Locations (1)
Arizona
- NIDDK, Phoenix — Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-06-06 |
| Est. Completion | 2027-02-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05545306
The ClinicalTrials.gov registry entry for NCT05545306 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 375 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 5 interventions — of which +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05545306 reports 1 study location spanning 1 distinct geographic area — top geographies include Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05545306 about?
NCT05545306 is a clinical study titled "The Effects of Increasing Caloric Intake on Diet-Induced Thermogenesis and 24h Energy Expenditure". 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...
What is the current status of trial NCT05545306?
This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2023-06-06. Estimated completion is 2027-02-02.
What conditions does trial NCT05545306 study?
This clinical trial studies the following conditions: Obesity, Healthy Volunteers, Normal Physiology. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05545306?
The interventions under investigation include: +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat (DIETARY_SUPPLEMENT), fasting (DIETARY_SUPPLEMENT), -50% of energy balance requirements. 50% of calories from carbohydrates, 20% from protein, and 30% from fat (DIETARY_SUPPLEMENT), +150% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat (DIETARY_SUPPLEMENT), +200% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05545306?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 375 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05545306 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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