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NCT04799301 · ClinicalTrials.gov registry record · Phase 1
Developing Biomarkers of Dietary Intake: Dose Dependent Measurement of Sugar Intake
A Phase 1 study of Healthy Volunteers and Diet Therapy, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04799301: Recruiting Phase 1 study of Healthy Volunteers and Diet Therapy, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT04799301 is a Phase 1 study of Healthy Volunteers and Diet Therapy that is actively recruiting participants, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 60 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04799301, a Phase 1 study of Healthy Volunteers and Diet Therapy, is actively recruiting participants, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
We will test biomarker diet relationships at the week 8, 10 and 12 sampling time points, using linear mixed effects models to evaluate single CIR biomarkers of SSB in plasma. Specifically, we will also test the time x group interaction by including it as a fixed effect in the mixed model analysis to evaluate the differences in the rate of CIR change over time across groups. Baseline CIR will be included as covariate in the mixed model analysis.
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 |
What NCT04799301 shows while recruiting
NCT04799301 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (88% lower).
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.
NCT04799301 reports a single indexed study location in Arizona.
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.
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).
Who is sponsoring clinical trial NCT04799301?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04799301's enrollment target sits among peer trials
60 109th of 283 higher than 163 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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