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2-5 Intermittent Caloric Restriction in HIV (2-5toWIN)

Primary Purpose

Human Immunodeficiency Virus, Metabolic Syndrome

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Intermittent fasting

Standard of Care

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus focused on measuring Fasting

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

-INCLUSION CRITERIA:

Aged 18 to 65 years
HIV RNA level less than or equal to 200 copies/mL for greater than or equal to1 year (1 measure greater than or equal to 200 allowed if also <500 and preceded and followed by one or more undetectable values)
Cluster of differentiation 4 (CD4) >200 cells/mL and no active opportunistic infection or malignancy
BMI greater than or equal to 30 kg/m^2
One or more components of the metabolic syndrome as defined below.
- Risk Factor: Waist circumference
  - Men: Defining Level: >102 cm
  - Women: Defining Level: >88 cm
- Risk Factor: Triglycerides, greater than or equal to 150 mg/dL
- Risk Factor: High density lipoprotein (HDL) cholesterol
  - Men: Defining Level: <40 mg/dL
  - Women: Defining Level: <50 mg/dL
- Risk Factor: Blood pressure, greater than or equal to 130 / greater than or equal to 85 mmHg
- Risk Factor: Fasting glucose, greater than or equal to 110 mg/dL
Fasting blood glucose >60 mg/dL at screening
Willingness to allow sample storage for future research
Able to provide informed consent

EXCLUSION CRITERIA:

Established diagnosis of diabetes mellitus use of anti-diabetes medications, or a hemoglobin A1C (HgbA1C) of >7.0%
History of eating disorder, uncontrolled mood or thought disorder, significant gastrointestinal disorder or malabsorption, or significant hepatic or renal impairment
Current use of medical therapy for overweight/obesity including phentermine, orlistat, lorcaserin, naltrexone/bupropion, and liraglutide or history of weight loss surgery. Concomitant use of medications with side effects known to potentially influence appetite are allowed if on a stable dose for at least 12 months
History of symptomatic hypoglycemia.
Use of systemic glucocorticoids (stable dose daily inhaled corticosteroid allowed)
Chronic viral hepatitis C; subjects with a history of hepatitis C successfully treated can enroll >12 months after sustained virologic response
Alcohol or substance use disorder in the past year as defined by Diagnostic and Statistical Manual (DSM)-V or positive urine drug screen
Current pregnancy, actively seeking to become pregnant or breastfeeding
Any serious health or other condition which, in the opinion of the PI or their designee, could potentially interfere with the ability of a subject to comply with the procedures and assessments of the protocol or to safely participate and complete the study.

Sites / Locations

National Institutes of Health Clinical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intermittent Fasting diet

Standard of Care diet

Arm Description

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.

HIV positive subjects with body mass index ≥30 kg/m2 (obese) receive nutritional and healthy lifestyle counseling for 12 weeks.

Outcomes

Primary Outcome Measures

Change in Weight

The effect of intermittent fasting was measured by change in weight between baseline and at week 12

Change in Insulin Sensitivity

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.

Secondary Outcome Measures

Change in Controlled Attenuation Parameter (CAP) Score

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

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 Lipid Panel Levels

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 C-reactive Protein (CRP) Levels

The effect of Intermittent fasting on biomarker of inflammation was measured by C-reactive protein (CRP) levels between baseline and week 12

Change in Beck Depression Inventory (BDI) Score

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.

Self-reported Compliance Rate With Assigned Diet

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.

Full Information

NCT ID

NCT03489109

First Posted

April 4, 2018

Last Updated

October 19, 2022

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

1. Study Identification

Unique Protocol Identification Number

NCT03489109

Brief Title

2-5 Intermittent Caloric Restriction in HIV

Acronym

2-5toWIN

Official Title

2-5 Intermittent Caloric Restriction for Weight Loss and Insulin Resistance in HIV-Infected Adults With Features of the Metabolic Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Terminated

Why Stopped

Slow/Insufficient accrual

Study Start Date

May 9, 2018 (Actual)

Primary Completion Date

December 17, 2021 (Actual)

Study Completion Date

December 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Human Immunodeficiency Virus, Metabolic Syndrome

Keywords

Fasting

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intermittent Fasting diet

Arm Type

Experimental

Arm Description

Arm Title

Standard of Care diet

Arm Type

Active Comparator

Arm Description

HIV positive subjects with body mass index ≥30 kg/m2 (obese) receive nutritional and healthy lifestyle counseling for 12 weeks.

Intervention Type

Behavioral

Intervention Name(s)

Intermittent fasting

Intervention Description

Subject will consume approximately 25% of their daily calories for 2 days per week. The other 5 days they will eat their normal diet

Intervention Type

Other

Intervention Name(s)

Standard of Care

Intervention Description

Subject will receive standard of care recommendations for healthy diet and lifestyle

Primary Outcome Measure Information:

Title

Change in Weight

Description

The effect of intermittent fasting was measured by change in weight between baseline and at week 12

Time Frame