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Clinical trialNCT03489109TerminatedInterventional

2-5 Intermittent Caloric Restriction in HIV

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment35Human Immunodeficiency VirusMetabolic Syndrome
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

  • Colleen M Hadigan, M.D.

    National Institute of Allergy and Infectious Diseases (NIAID)

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • National Institutes of Health Clinical Center

    Bethesda, Maryland, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
9 May 2018
Primary completion
17 Dec 2021
Completion
17 Dec 2021
Last update posted
21 Oct 2022
Registered enrollment
35
Registry id
NCT03489109

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.