2-5 Intermittent Caloric Restriction for Weight Loss and Insulin Resistance in HIV-Infected Adults With Features of the Metabolic Syndrome
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Human Immunodeficiency Virus
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Change in Insulin Sensitivity
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief 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.
Detailed Description
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 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in Insulin Sensitivity
Time Frame: Assessed before 12-week intervention (baseline) and at week 12
The effect of intermittent fasting on insulin sensitivity was measured by change in homeostatic model assessment of insulin resistance (HOMA-IR) between baseline and week 12. Homeostasis model assessment of insulin resistance (HOMA-IR) is a method to measure insulin sensitivity. Optimal insulin sensitivity is a HOMA-IR ratio less than 1. Levels above 1.9 signal early insulin resistance, while levels above 2.9 signal significant insulin resistance.
Change in Weight
Time Frame: Assessed before 12-week intervention (baseline) and at week 12
The effect of intermittent fasting was measured by change in weight between baseline and at week 12
Secondary Outcomes
- Self-reported Compliance Rate With Assigned Diet(Compliance reported at Week 12)
- Change in Lipid Panel Levels(Assessed before 12-week intervention (baseline) and at week 12)
- Change in Beck Depression Inventory (BDI) Score(Assessed before 12-week intervention (baseline) and at week 12)
- Change in Controlled Attenuation Parameter (CAP) Score(Assessed before 12-week intervention (baseline) and at week 12)
- Change in Visceral Adipose Tissue(Assessed before 12-week intervention (baseline) and at week 12)
- Change in C-reactive Protein (CRP) Levels(Assessed before 12-week intervention (baseline) and at week 12)