An interventional study of Intermittent fasting and Standard of Care in Human Immunodeficiency Virus and Metabolic Syndrome, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-10-21.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Not applicable, Interventional, and Treatment
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:
At the baseline visit, participants will have:
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.
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.
2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.
This study's enrollment of 35 is below the median of 60 across 1,572 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Compared within Metabolic Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Acquired Immunodeficiency Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
One or more components of the metabolic syndrome as defined below.
Risk Factor: Waist circumference
Risk Factor: High density lipoprotein (HDL) cholesterol
EXCLUSION CRITERIA:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 consume approximately 25% of their daily calories for 2 days per week. The other 5 days they will eat their normal diet
Subject will receive standard of care recommendations for healthy diet and lifestyle
Change in Weight
The effect of intermittent fasting was measured by change in weight between baseline and at week 12
Time frame: 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.
Time frame: Assessed before 12-week intervention (baseline) and at week 12
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Compliance reported at Week 12
Of the 35 subjects who were consented to protocol, four subjects withdrew prior to start of study, one subject was screen failure and 30 subjects started the study.
| Milestone | Intermittent Fasting Diet | Standard of Care Diet |
|---|---|---|
| Started | 14 | 16 |
| Completed | 13 | 14 |
| Not completed | 1 | 2 |
| Withdrew: Lost to follow-up | 1 | 2 |
The effect of intermittent fasting was measured by change in weight between baseline and at week 12
| kilograms | Intermittent Fasting Diet | Standard of Care Diet |
|---|---|---|
| Change in Weight | -1.5 ± 4.9 | -1.8 ± 3.8 |
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.
| unitless | Intermittent Fasting Diet | Standard of Care Diet |
|---|---|---|
| Change in Insulin Sensitivity | -0.9 ± 1.7 | -1.5 ± 3.3 |
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.
| dB/m | Intermittent Fasting Diet | Standard of Care Diet |
|---|---|---|
| Change in Controlled Attenuation Parameter (CAP) Score | -3.8 ± 28.3 | -6.6 ± 74.6 |
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.
| mg | Intermittent Fasting Diet | Standard of Care Diet |
|---|---|---|
| Change in Visceral Adipose Tissue | -224 ± 206 | -149 ± 541 |
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.
| mg/dL | Intermittent Fasting Diet | Standard of Care Diet |
|---|---|---|
| Triglyceride | -4.8 ± 23.5 | 0 ± 22.9 |
| HDL Cholesterol | -1.3 ± 3.4 | -2.7 ± 5.7 |
| LDL Cholesterol | 1.6 ± 17.0 | 1.6 ± 10.9 |
| Total Cholesterol | -0.6 ± 17.4 | -1 ± 12.5 |
The effect of Intermittent fasting on biomarker of inflammation was measured by C-reactive protein (CRP) levels between baseline and week 12
| mg/L | Intermittent Fasting Diet | Standard of Care Diet |
|---|---|---|
| Change in C-reactive Protein (CRP) Levels | 1.7 ± 4.8 | 0.3 ± 4.9 |
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.
| Units on a scale | Intermittent Fasting Diet | Standard of Care Diet |
|---|---|---|
| Change in Beck Depression Inventory (BDI) Score | 3.5 ± 6.8 | 8.6 ± 7.7 |
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.
| Percentage of Compliance | Intermittent Fasting Diet | Standard of Care Diet |
|---|---|---|
| Self-reported Compliance Rate With Assigned Diet | 80 ± 16 | 67 ± 22 |
Collected over 24 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intermittent Fasting Diet | 0/14 (0%) | 0/14 (0%) | 9/14 (64.3%) |
| Standard of Care Diet | 0/16 (0%) | 0/16 (0%) | 7/16 (43.8%) |
| Event | Intermittent Fasting Diet | Standard of Care Diet |
|---|---|---|
| Blood creatinine increasedInvestigations | 1/14 | 3/16 |
| Diabetes mellitusEndocrine disorders | 2/14 | 0/16 |
| Blood bicarbonate decreasedInvestigations | 2/14 | 1/16 |
| Impaired fasting glucoseEndocrine disorders | 1/14 | 2/16 |
| Localised oedemaCardiac disorders | 1/14 | 0/16 |
| ConstipationGastrointestinal disorders | 1/14 | 1/16 |
| Aspartate aminotransferase increasedInvestigations | 1/14 | 0/16 |
| Blood cholesterol increasedInvestigations | 1/14 | 1/16 |
| Low density lipoprotein increasedInvestigations | 1/14 | 1/16 |
| HeadacheNervous system disorders | 1/14 | 0/16 |
| Age, Categorical(Participants) | Intermittent Fasting Diet | Standard of Care Diet | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 14 | 16 | 30 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Intermittent Fasting Diet | Standard of Care Diet | Total |
|---|---|---|---|
| Female | 8 | 8 | 16 |
| Male | 6 | 8 | 14 |
| Ethnicity (NIH/OMB)(Participants) | Intermittent Fasting Diet | Standard of Care Diet | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 2 | 5 |
| Not Hispanic or Latino | 10 | 14 | 24 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Intermittent Fasting Diet | Standard of Care Diet | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 10 | 11 | 21 |
| White | 2 | 3 | 5 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Weight(kilograms) | Intermittent Fasting Diet | Standard of Care Diet | Total |
|---|---|---|---|
| Mean | 112.1 ± 18.4 | 109.6 ± 14.9 | 110.8 ± 16.4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2018 to primary completion in Dec 2021, 43 months.
Results were first posted in Oct 2022, 9 months after primary completion.
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