Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03489109
Recruitment Status : Recruiting
First Posted : April 5, 2018
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Tracking Information
First Submitted Date  ICMJE April 4, 2018
First Posted Date  ICMJE April 5, 2018
Last Update Posted Date March 22, 2019
Actual Study Start Date  ICMJE May 9, 2018
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
Change in weight and insulin sensitivity as measured by HOMA-IR [ Time Frame: Baseline, week 12, week 24 ]
Weight
Original Primary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
Change in weight and insulin sensitivity as measured by HOMA-IR [ Time Frame: Baseline, week 12, week 24 ]
Change History Complete list of historical versions of study NCT03489109 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
  • Tolerability of ICR [ Time Frame: Baseline, Week 12, Week 24 ]
  • Change in lipid levels, metabolic biomarkers, biomarkers of inflammation and immune activation, and mood. [ Time Frame: Baseline, Week 12, Week 24 ]
  • Change in body composition, including visceral adiposity abd hepatic steatosis. [ Time Frame: Baseline, Week 12, Week 24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 2-5 Intermittent Caloric Restriction for Weight Loss and Insulin Resistance in HIV-Infected Adults With Features of the Metabolic Syndrome
Official Title  ICMJE 2-5 Intermittent Caloric Restriction for Weight Loss and Insulin Resistance in HIV-Infected Adults With Features of the Metabolic Syndrome
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 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Human Immunodeficiency Virus
  • Metabolic Syndrome
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Behavioral: Intermittent fasting
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 4, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2022
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

-INCLUSION CRITERIA:

  1. Age 18 - 65 years
  2. 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)
  3. CD4 > 200 cells/mL and no active opportunistic infection or malignancy
  4. BMI greater than or equal to 30 kg/m^2
  5. 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
  6. Fasting blood glucose > 60 mg/dL at screening
  7. Willingness to allow sample storage for future research

EXCLUSION CRITERIA:

  1. Established diagnosis of diabetes mellitus use of anti-diabetes medications, or a HgbA1C of >7.0 %
  2. History of eating disorder, uncontrolled mood or thought disorder, significant gastrointestinal disorder or malabsorption, or significant hepatic or renal impairment
  3. 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
  4. History of symptomatic hypoglycemia.
  5. Use of systemic glucocorticoids (stable dose daily inhaled corticosteroid allowed)
  6. Chronic viral hepatitis C; subjects with a history of hepatitis C successfully treated can enroll >12 months after sustained virologic response
  7. Alcohol or substance use disorder in the past year as defined by DSM-V or positive urine drug screen
  8. Current pregnancy, actively seeking to become pregnant or breastfeeding
  9. Any serious health or other condition which, in the opinion of the Principal Investigator 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cheryl L. Chairez (301) 496-3840 chairezc@mail.nih.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03489109
Other Study ID Numbers  ICMJE 180075
18-I-0075
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Colleen M Hadigan, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date March 14, 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP