2-5 Intermittent Caloric Restriction in HIV
- Conditions
- Human Immunodeficiency VirusMetabolic Syndrome
- Interventions
- Other: Standard of CareBehavioral: Intermittent fasting
- Registration Number
- NCT03489109
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care diet Standard of Care HIV positive subjects with body mass index ≥30 kg/m2 (obese) receive nutritional and healthy lifestyle counseling for 12 weeks. Intermittent Fasting diet Intermittent fasting HIV positive subjects with body mass index ≥30 kg/m2 (obese) consume approximately 25% of their daily calories for 2 non-consecutive days per week, normal diet for the other 5 days, and receive healthy lifestyle counseling for 12 weeks.
- Primary Outcome Measures
Name Time Method Change in Insulin Sensitivity 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 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 Outcome Measures
Name Time Method Self-reported Compliance Rate With Assigned Diet Compliance reported at Week 12 Compliance with assigned diet was assessed by participant self-reported rating. Participants used a self rating score of 0-100% with 0% = noncompliant and 100% = completely compliant with assigned diet. Compliance rate per participant was calculated using average of all daily reported scores. The overall compliance rate was averaged over all participants to get the mean compliance.
Change in Lipid Panel Levels Assessed before 12-week intervention (baseline) and at week 12 The effect of Intermittent fasting was measured by change in lipid profile levels between baseline and week 12. Lipid profile levels assessed include serum triglyceride, HDL cholesterol, LDL cholesterol, and total cholesterol levels.
Change in Beck Depression Inventory (BDI) Score Assessed before 12-week intervention (baseline) and at week 12 The effect of Intermittent fasting on mood was evaluated by change in the Beck Depression Inventory (BDI) score between baseline and week 12. The Beck Depression Inventory (BDI) is a 21-item measure of depression with each question on a 4-point scale ranging from 0=minimal to 3 = more severe (full list score values = 0,1,2,3). Total scores are a sum of individual items. Minimal depression = 0-13, mild depression = 14-19, moderate depression = 20-28, and severe depression = 29-63. The maximum score is 63 and the minimum possible score is zero.
Change in Controlled Attenuation Parameter (CAP) Score Assessed before 12-week intervention (baseline) and at week 12 The effect of Intermittent fasting on body composition was evaluated using Controlled Attenuation Parameter (CAP) score from Fibroscan. Measurement of controlled attenuation parameter (CAP) is a non-invasive quantitative and qualitative assessment of liver steatosis. CAP measures ultrasonic attenuation (in dB/m) at a frequency of 3.5 MHz (on a go-and-return path). Values range from 100 to 400 dB/m. Higher levels indicate increased hepatic fat.
Change in Visceral Adipose Tissue Assessed before 12-week intervention (baseline) and at week 12 The effect of intermittent fasting was evaluated by change in visceral adiposity using total body dual energy x-ray absorptiometry (DEXA) between baseline and at week 12.
Change in C-reactive Protein (CRP) Levels Assessed before 12-week intervention (baseline) and at week 12 The effect of Intermittent fasting on biomarker of inflammation was measured by C-reactive protein (CRP) levels between baseline and week 12
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States