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Developing Biomarkers of Dietary Intake: Dose Dependent Measurement of Sugar Intake
NCT04799301 · View on ClinicalTrials.gov ↗
Study Summary
Background: Diet is one of the most modifiable behaviors affecting health. But diet assessment measures that are based on self-report can be inaccurate. Researchers want better ways to address the role of diet in chronic disease. They want to see if stable isotopes can be used to better assess what people eat. Objective: To see if stable isotopes can help scientists identify things people eat. Eligibility: Healthy adults ages 18 to 65 Design: Participants will be screened with a medical history and physical exam. They will have blood and urine tests. These tests will be repeated during the study. Participants will stay in the inpatient unit of the NIH in Phoenix, Arizona, for 13 weeks. For 7 days, participants will eat a diet prepared by the NIH kitchen. They will get balanced meals that are 50% carbohydrates, 20% protein, and 30% fat. Then participants will be randomly placed on one of 3 diets containing different percentages of carbohydrates from soda. Participants height and weight will be measured. The amount of fat and muscle in their body will be measured by body scans that are similar to x-rays. Participants will have oral glucose tolerance tests. They will consume a sugar drink and then give blood samples over 3 hours. Participants will give hair and stool samples. Participants will complete a diet questionnaire. It assesses their food intake over 24 hours. Participants will complete behavioral questionnaires and computer performance tests. Participants will have fat biopsies taken from their stomach and thigh. Participants will have three 24-hour stays in a metabolic chamber. It is used to measure metabolism.
Conditions Studied
Interventions
- BEHAVIORAL Diet with no soda
- BEHAVIORAL Diet with 50% of carb intake from soda
- BEHAVIORAL Diet with 20% of carb intake from soda
Study Locations (1)
Arizona
- NIDDK, Phoenix — Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-02-23 |
| Est. Completion | 2028-01-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04799301
The ClinicalTrials.gov registry entry for NCT04799301 describes a study currently listed as recruiting. It is categorized as Phase 1, 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 60 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 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 3 interventions — of which Diet with no soda 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: NCT04799301 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 NCT04799301 about?
NCT04799301 is a clinical study titled "Developing Biomarkers of Dietary Intake: Dose Dependent Measurement of Sugar Intake". Background: Diet is one of the most modifiable behaviors affecting health. But diet assessment measures that are based on self-report can be inaccurate. Researchers want better ways to address the role of diet in chronic disease. They want to see if stable isotopes can be used to better assess what...
What is the current status of trial NCT04799301?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2022-02-23. Estimated completion is 2028-01-01.
What conditions does trial NCT04799301 study?
This clinical trial studies the following conditions: Healthy Volunteers, Diet Therapy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04799301?
The interventions under investigation include: Diet with no soda (BEHAVIORAL), Diet with 50% of carb intake from soda (BEHAVIORAL), Diet with 20% of carb intake from soda (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04799301?
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 NCT04799301 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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