2-5 Intermittent Caloric Restriction in HIV

NCT03489109 | Terminated Results

• 1 other identifier: 180075
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus; Metabolic Syndrome

Keywords

Fasting

Outcome Measures

Primary Outcomes (2)

• Change in Weight

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

  Assessed before 12-week intervention (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.

  Assessed before 12-week intervention (baseline) and at week 12

Secondary Outcomes (6)

• 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 Lipid Panel Levels

  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

• Change in Beck Depression Inventory (BDI) Score

  Assessed before 12-week intervention (baseline) and at week 12

Study Arms (2)

Intermittent Fasting diet

EXPERIMENTAL

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.

Behavioral: Intermittent fasting

Standard of Care diet

ACTIVE COMPARATOR

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

Other: Standard of Care

Interventions

Intermittent fasting BEHAVIORAL

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

Intermittent Fasting diet

Standard of Care OTHER

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

Standard of Care diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Metabolic Syndrome; Fasting

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Due to the COVID 19 pandemic, study enrollment was stopped and the study did not sufficiently enroll to perform statistical comparisons as originally planned.

Results Point of Contact

• Title: Hadigan, Colleen
• Organization: Clinical Center

hadiganc@nih.gov

+1 301 594 5754

Study Officials

• Colleen M Hadigan, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 5, 2018
• Study Start: May 9, 2018
• Primary Completion: December 17, 2021
• Study Completion: December 17, 2021
• Last Updated: October 21, 2022
• Results First Posted: October 13, 2022

Record last verified: 2021-12

Locations

US (1)