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NCT03489109 · ClinicalTrials.gov registry record · NA
2-5 Intermittent Caloric Restriction in HIV
A NA study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- NA
- Development phase
- 35
- Enrollment target
NCT03489109: Clinical Trial NA study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03489109 is a NA study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 35 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03489109, a NA study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
Study Summary
Background: Weight gain can lead to obesity and diabetes even in people living with human immunodeficiency virus (HIV). Researchers want to see if the technique intermittent calorie restriction can help overweight people with HIV as an alternative to traditional diets. Objective: To see if intermittent calorie restriction leads to weight loss and improved blood sugar in obese people with HIV. Eligibility: Adults ages 18-65 with HIV who are obese and do not have diabetes Design: Participants will be screened with a medical history, physical exam, and blood and urine tests. Before starting treatment, participants will: * Have a nutritional consultation * Get a pedometer to record daily steps * Test a restricted diet for 1 day * Have a body x-ray At the baseline visit, participants will have: * Blood drawn after they drink a sugar drink * Questions about their health and eating * A nutritional consultation * Resting energy expenditure measured. Participants will fast overnight. Then they will lie down while a plastic bubble goes over the head and a plastic sheet covers the upper body. Oxygen flows into the bubble. * Liver stiffness test. A wand on the stomach releases sound waves like an ultrasound. For 12 weeks, some participants will be on a standard diet. Others will restrict how much food they eat 2 days a week. On those days they will eat about 25% of their recommended calories. Participants will keep a diary of their diet and steps. Participants will have 4 visits during the 12-week diet and 1 visit 12 weeks after the diet ends. They will repeat previous tests.
Primary Outcome
The effect of intermittent fasting was measured by change in weight between baseline and at week 12
Interventions
- OTHER Standard of Care
- BEHAVIORAL Intermittent fasting
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2018-05-09 |
| Est. Completion | 2021-12-17 |
| Phase | NA |
Why NCT03489109 stopped before completion
NCT03489109 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.
NCT03489109 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03489109 about?
NCT03489109 is a clinical study titled "2-5 Intermittent Caloric Restriction in HIV". Background: Weight gain can lead to obesity and diabetes even in people living with human immunodeficiency virus (HIV). Researchers want to see if the technique intermittent calorie restriction can help overweight people with HIV as an alternative to traditional diets. Objective: To see if interm...
What is the current status of trial NCT03489109?
This trial is currently terminated. It is a NA study. The enrollment target is 35 participants. The study started on 2018-05-09. Estimated completion is 2021-12-17.
What interventions are being tested in trial NCT03489109?
The interventions under investigation include: Standard of Care (OTHER), Intermittent fasting (BEHAVIORAL).
Who is sponsoring clinical trial NCT03489109?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03489109's enrollment target sits among peer trials
35 1564th of 2000 higher than 431 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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