2-5 Intermittent Caloric Restriction for Weight Loss and Insulin Resistance in HIV-Infected Adults With Features of the Metabolic Syndrome
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|ClinicalTrials.gov Identifier: NCT03489109|
Recruitment Status : Recruiting
First Posted : April 5, 2018
Last Update Posted : March 22, 2019
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.
To see if intermittent calorie restriction leads to weight loss and improved blood sugar in obese people with HIV.
Adults ages 18-65 with HIV who are obese and do not have diabetes
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.
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus Metabolic Syndrome||Behavioral: Intermittent fasting||Phase 2|
The high prevalence of obesity coupled with chronic inflammation and immune activation places human immunodeficiency virus (HIV)-infected individuals at increased risk for metabolic complications emphasizing the need for more aggressive management of obesity and related co-morbidities in the aging HIV-infected population. The most effective treatment for obesity and metabolic syndrome is lifestyle modification, usually with a combination of caloric restriction and increased exercise. Intermittent caloric restriction (ICR) or intermittent fasting simplifies caloric restriction by severely limiting calories only a few days per week and allowing ad lib diet on the other days. Weight loss benefits are similar to those seen with conventional diets, however, data suggests possible added health benefits from intermittent fasting.
We propose to study the benefits of a 2-5 intermittent caloric restriction (ICR) strategy on weight, insulin resistance, and cardiovascular disease markers in obese HIV-infected adults with features of the metabolic syndrome. In a prospective pilot study, 50 HIVinfected adults will be randomized 1:1 to ICR or standard of care instruction of healthy diet and lifestyle for a 12-week intervention period. We hypothesize that ICR (2 days per week) will be an effective and acceptable diet strategy that will result in significant weight reduction, improvements in insulin sensitivity and related metabolic parameters.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||2-5 Intermittent Caloric Restriction for Weight Loss and Insulin Resistance in HIV-Infected Adults With Features of the Metabolic Syndrome|
|Actual Study Start Date :||May 9, 2018|
|Estimated Primary Completion Date :||January 31, 2022|
|Estimated Study Completion Date :||January 31, 2022|
Experimental: Intermittent Fasting
Subject will consume approximately 25% of their daily calories for 2 days per week. The other 5 days they will eat their normal diet.
Behavioral: Intermittent fasting
Subject will consume approximately 25% of their daily calories for 2 days per week. The other 5 days they will eat their normal diet
- Change in weight and insulin sensitivity as measured by HOMA-IR [ Time Frame: Baseline, week 12, week 24 ]Weight
- Tolerability of ICR [ Time Frame: Baseline, Week 12, Week 24 ]Subject's tolerability to ICR and compliance as recorded on subject diary.
- Change in lipid levels, metabolic biomarkers, biomarkers of inflammation and immune activation, and mood. [ Time Frame: Baseline, Week 12, Week 24 ]Change in lipids levels, metabolic biomarkers, biomarkers of inflammation and immune activation. Mood changes measured by subject questionnaires.
- Change in body composition, including visceral adiposity abd hepatic steatosis. [ Time Frame: Baseline, Week 12, Week 24 ]Change in body composition, including visceral adiposity and hepatic steatosis measured by fibroscan.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489109
|Contact: Cheryl L. Chairez||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Colleen M Hadigan, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|