Human Immunodeficiency Virus2-5toWINNCT03489109
2-5 Intermittent Caloric Restriction in HIV
A study testing Intermittent fasting in people with Human Immunodeficiency Virus and Metabolic Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Human Immunodeficiency Virus, Metabolic Syndrome
- What is being tested?
- Intermittent fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2018to 17 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Human Immunodeficiency Virus, Metabolic Syndrome
- Being tested
- Intermittent fasting, Standard of Care
- Keywords
- Fasting
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Metabolic Syndrome, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent fastingBehavioural
Subject will consume approximately 25% of their daily calories for 2 days per week. The other 5 days they will eat their normal diet
Standard of CareOther
Subject will receive standard of care recommendations for healthy diet and lifestyle
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
The effect of intermittent fasting was measured by change in weight between baseline and at week 12
Measured: 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.
Measured: Assessed before 12-week intervention (baseline) and at week 12
Secondary outcomes (6)
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.
Measured: Assessed before 12-week intervention (baseline) and at week 12
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.
Measured: Assessed before 12-week intervention (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.
Measured: Assessed before 12-week intervention (baseline) and at week 12
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
Measured: Assessed before 12-week intervention (baseline) and at 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.
Measured: Assessed before 12-week intervention (baseline) and at week 12
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.
Measured: Compliance reported at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start9 May 2018
- Primary completion17 Dec 2021
- Study completion17 Dec 2021
Why it stopped: Slow/Insufficient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Colleen M Hadigan, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489109
- Sponsor's protocol ID
- 180075
- Acronym
- 2-5toWIN
- Status last verified
- Dec 2021
- First submitted
- 4 Apr 2018
- Last updated
- 21 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2-5 Intermittent Caloric Restriction for Weight Loss and Insulin Resistance in HIV-Infected Adults With Features of the Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03489109
- Acronym / sponsor ID
- 2-5toWIN / 180075
- Conditions
- Human Immunodeficiency Virus, Metabolic Syndrome
- Keywords
- Fasting
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow/Insufficient accrual
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 9 May 2018 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Posted 13 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent Fasting diet | Experimental | Behavioral: Intermittent fastingHIV 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. |
| Standard of Care diet | Active comparator | Other: Standard of CareHIV positive subjects with body mass index ≥30 kg/m2 (obese) receive nutritional and healthy lifestyle counseling for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent fastingSubject will consume approximately 25% of their daily calories for 2 days per week. The other 5 days they will eat their normal diet | Behavioural | Intermittent Fasting diet |
| Standard of CareSubject will receive standard of care recommendations for healthy diet and lifestyle | Other | Standard of Care diet |
Primary outcome
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
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.
6 secondary outcomes
Change in Controlled Attenuation Parameter (CAP) Score
Time frame: 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
Change in Lipid Panel Levels
Time frame: 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
Change in Beck Depression Inventory (BDI) Score
Time frame: Assessed before 12-week intervention (baseline) and at week 12
Self-reported Compliance Rate With Assigned Diet
Time frame: Compliance reported at Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colleen M Hadigan, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent fasting in people with Human Immunodeficiency Virus and Metabolic Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weight (time frame: Assessed before 12-week intervention (baseline) and at week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.