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

October 19, 2022 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

-INCLUSION CRITERIA:

  1. Aged 18 to 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. Cluster of differentiation 4 (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
  8. Able to provide informed consent

EXCLUSION CRITERIA:

  1. Established diagnosis of diabetes mellitus use of anti-diabetes medications, or a hemoglobin A1C (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 Diagnostic and Statistical Manual (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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intermittent Fasting diet
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
Subject will consume approximately 25% of their daily calories for 2 days per week. The other 5 days they will eat their normal diet
Active Comparator: Standard of Care diet
HIV positive subjects with body mass index ≥30 kg/m2 (obese) receive nutritional and healthy lifestyle counseling for 12 weeks.
Other: Standard of Care
Subject will receive standard of care recommendations for healthy diet and lifestyle

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Assessed before 12-week intervention (baseline) and at week 12
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.
Assessed before 12-week intervention (baseline) and at week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Controlled Attenuation Parameter (CAP) Score
Time Frame: 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.
Assessed before 12-week intervention (baseline) and at week 12
Change in Visceral Adipose Tissue
Time Frame: 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.
Assessed before 12-week intervention (baseline) and at week 12
Change in Lipid Panel Levels
Time Frame: 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.
Assessed before 12-week intervention (baseline) and at week 12
Change in C-reactive Protein (CRP) Levels
Time Frame: 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
Assessed before 12-week intervention (baseline) and at week 12
Change in Beck Depression Inventory (BDI) Score
Time Frame: 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.
Assessed before 12-week intervention (baseline) and at week 12
Self-reported Compliance Rate With Assigned Diet
Time Frame: 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.
Compliance reported at Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Colleen M Hadigan, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 9, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 17, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 17, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 180075

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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