Nutrition Program for Insulin Resistance in HIV

(NOURISH-OK Trial)

Overseen By Lacey Caywood, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Must be taking: Antiretroviral therapy

Disqualifiers: Cancer, End-stage renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

234 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how food insecurity affects insulin resistance in people with HIV. It will test a "food as medicine" approach using a special 12-week food assistance program, called the NOURISH Food Box, to help manage pre-diabetes, diabetes, obesity, and related conditions. Participants will receive a food box with items that reduce inflammation, or they might be in a control group and receive the box later. The trial seeks individuals living with HIV who have at least one risk factor for insulin resistance, such as being overweight or having high blood pressure, and are currently using antiretroviral therapy.

As an unphased trial, this study offers a unique opportunity to contribute to understanding the impact of nutrition on health for those living with HIV.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the study focuses on nutrition and insulin resistance, it might not require changes to your existing medication regimen.

What prior data suggests that the NOURISH Food Box is safe for individuals with HIV?

Research has shown that the NOURISH Food Box, which uses a "food as medicine" approach, is generally safe for people with insulin resistance and HIV. Studies on similar programs have found that providing meals or groceries tailored to medical needs can improve health without causing serious side effects. Specifically, this program has not reported any major negative effects, making it a promising way to boost health through better nutrition. This approach aims to lower insulin resistance and improve conditions like pre-diabetes and obesity by offering healthier food choices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the NOURISH Food Box because it offers a fresh approach to managing insulin resistance in people living with HIV. Unlike standard treatments that often focus on medication, this program emphasizes dietary changes by providing a 12-week supply of low Dietary Inflammatory Index (DII) foods. This focus on reducing dietary inflammation could help improve insulin sensitivity without relying solely on pharmaceuticals, offering a more natural and potentially sustainable way to manage the condition.

What evidence suggests that the NOURISH Food Box is effective for insulin resistance in HIV?

Research has shown that the NOURISH Food Box, which participants in this trial may receive, is designed to help people with HIV by providing healthy foods that can reduce insulin resistance. This approach aids in managing insulin resistance, which can lead to conditions like diabetes and obesity. Studies on similar "food as medicine" programs have demonstrated their effectiveness in managing long-term diseases. By eating better, people can reduce inflammation and insulin resistance, leading to improved health. Early results suggest that focusing on nutrition can be a powerful way to manage health for those with HIV. ^{1 3 4 6 7}

Who Is on the Research Team?

Marianna S Wetherill, PhD, MPH, RD

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

This trial is for HIV-positive individuals with an income below 400% of the federal poverty level who are at risk for insulin resistance due to factors like being overweight, aged 45 or older, having a family history of diabetes, or leading a physically inactive lifestyle. Participants must have experienced food insecurity recently and been on antiretroviral therapy for at least six months.

Inclusion Criteria

I am HIV-positive and my income is below 400% of the federal poverty level.

English-speaking

I have at least one risk factor for insulin resistance.

Exclusion Criteria

Plan to move outside of Oklahoma during the study period

Participating in another health-related research study

Does not have an address that can accept home-delivered groceries

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational

Cross-sectional survey and one-month observational sub-study to collect dietary intake and gut microbiome samples

4 weeks

Multiple visits for data collection

Intervention

12-week NOURISH-OK intervention with home-delivered grocery and cooking self-care to address nutrition disparities

12 weeks

Regular visits for intervention and data collection

Follow-up

Participants are monitored for changes in food security, dietary intake, and insulin sensitivity

4 weeks

Follow-up visits at 6, 12, and 16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NOURISH Food Box

Trial Overview The NOURISH-OK Study is testing whether providing healthy food boxes can improve insulin sensitivity in people living with HIV. The study will give participants these special food boxes designed to promote better self-care behaviors and teach them how to use the foods effectively.

How Is the Trial Designed?

Group I: NOURISH Food Box Experimental Treatment 1 Intervention

12-week food assistance with low Dietary Inflammatory Index (DII) foods

Group II: Wait-list Control Active Control 1 Intervention

Wait-list control group eligible to receive NOURISH box after study period

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

HIV-infected individuals had lower diet quality, as measured by the Healthy Eating Index (HEI), compared to those without HIV, with HIV-infected women scoring particularly low (49.2) compared to HIV-infected men (55.7) and HIV-uninfected men (61.8).

Higher diet quality in HIV-infected individuals was associated with lower levels of the immune activation marker sCD14, suggesting that improving diet quality may help reduce inflammation and metabolic issues in people with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet Quality Is Low and Differs by Sex in People with HIV. Weiss, JJ., Sanchez, L., Hubbard, J., et al.[2023]

The NOURISH-OK study aims to investigate how food insecurity affects insulin resistance in people living with HIV (PLWH) by analyzing data from 500 participants across different levels of food insecurity, focusing on dietary habits and health outcomes.

This research will use a comprehensive approach, including blood samples and dietary assessments, to identify links between food insecurity, diet, and chronic inflammation, ultimately aiming to develop interventions that promote healthier eating to combat insulin resistance in PLWH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unpacking determinants and consequences of food insecurity for insulin resistance among people living with HIV: Conceptual framework and protocol for the NOURISH-OK study. Wetherill, MS., Bakhsh, C., Caywood, L., et al.[2022]

Seventeen community-based, home-delivered meal programs have been established in major cities over the past decade to address the specialized nutritional needs of homebound individuals living with HIV/AIDS.

These programs not only provide meals but also include nutrition counseling and regular evaluations, highlighting the importance of clinical dietitians and public health nutritionists in referring clients to these essential services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-delivered meal programs for homebound people with HIV/AIDS. Kraak, VI.[2013]

This scoping review identified 64 relevant studies and 76 resources related to nutrition and food programming for people living with HIV in Canada, highlighting a significant reliance on charitable food provision services.

The findings suggest an unequal distribution of resources across Canada, indicating a need for program expansion to better serve diverse populations and improve health outcomes for individuals living with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring current nutritional programming and resources available to people living with HIV in Canada: a scoping review. Mannette, J., Zhang, Y., Rothfus, M., et al.[2023]

The Visiting Nurse Service HIV/Home Delivered Meals Program provided 50 clients with HIV/AIDS energy-enhanced meals and nutrition support over 6 months, leading to improved food consumption and weight management for many participants.

Out of 35 participants assessed, 13 gained weight on average by 6 pounds, and the program helped increase the number of participants considered to be 'doing well' from 14 to 19, demonstrating the effectiveness of dietitian-led medical nutrition therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A community-based, interagency approach by dietitians to provide meals, medical nutrition therapy, and education to clients with HIV/AIDS. Topping, CM., Humm, DC., Fischer, RB., et al.[2006]

Undernutrition is commonly associated with HIV infection, particularly in the later stages of the disease, and can lead to severe wasting and cachexia.

Dietary adjustments may offer a simple and cost-effective way to alleviate undernutrition in individuals with HIV, potentially improving their clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional and metabolic abnormalities in pre-AIDS HIV infection. Faintuch, J., Soeters, PB., Osmo, HG.[2006]

In a study of 178 women (113 HIV-infected and 65 HIV-uninfected), heavy intensity physical activity was linked to lower insulin resistance (HOMA-IR), highlighting the importance of exercise for metabolic health.

A diet high in sweets was associated with increased insulin resistance, suggesting that reducing sugar intake could be beneficial for managing insulin sensitivity, especially in women with or at risk for HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between diet and physical activity on insulin resistance in the Women's Interagency HIV Study. Hessol, NA., Ameli, N., Cohen, MH., et al.[2021]

In a study involving 1815 malnourished HIV-infected patients starting antiretroviral therapy (ART), those receiving lipid-based nutritional supplements with added vitamins and minerals (LNS-VM) showed greater improvements in nutritional measures compared to those receiving supplements without added vitamins and minerals (LNS).

The LNS-VM group experienced significant increases in weight, body mass index, and mid-upper arm circumference after starting ART, indicating that vitamin and mineral supplementation can enhance nutritional recovery, although it did not affect appetite.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects on anthropometry and appetite of vitamins and minerals given in lipid nutritional supplements for malnourished HIV-infected adults referred for antiretroviral therapy: results from the NUSTART randomized controlled trial. Rehman, AM., Woodd, S., PrayGod, G., et al.[2022]

A 14-week group intervention was developed to improve both body image satisfaction and dietary habits specifically for gay and bisexual men living with HIV/AIDS, addressing their unique health challenges.

Improving body image is crucial as it can positively influence dietary habits, which are essential for maintaining a strong immune system in individuals with HIV and AIDS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A group intervention to improve body image satisfaction and dietary habits in gay and bisexual men living with HIV/AIDS. Feldman, MB., Torino, JA., Swift, M.[2017]

Citations

1. withpower.com withpower.com/trial/phase-food-insecurity-8-2024-e79a8?condition=HIV%2FAIDS&overallStatus=Recruiting&hasNoPlacebo=false

Nutrition Program for Insulin Resistance in HIV The NOURISH Food Box treatment is unique because it addresses insulin resistance in people living with HIV by providing medically-tailored food boxes to combat ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36225538/

Conceptual framework and protocol for the NOURISH-OK study NOURISH-OK will use a novel, multi-level, integrated framework to explore how food insecurity contributes to insulin resistance among PLWH.

3. frontiersin.org frontiersin.org/journals/clinical-diabetes-and-healthcare/articles/10.3389/fcdhc.2022.947552/epub

Conceptual framework and protocol for the NOURISH-OK ... Unpacking determinants and consequences of food insecurity for insulin resistance among people living with HIV: Conceptual framework and ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001343

A Systematic Review of “Food Is Medicine” Randomized ... This review identified a total of 14 randomized controlled trials of Food Is Medicine interventions in the United States with noncommunicable disease outcomes.

5. researchgate.net researchgate.net/publication/362728066_Unpacking_determinants_and_consequences_of_food_insecurity_for_insulin_resistance_among_people_living_with_HIV_Conceptual_framework_and_protocol_for_the_NOURISH-OK_study

Conceptual framework and protocol for the NOURISH-OK ... Specifically, it will explore how food insecurity may operate as an intermediary risk factor for insulin resistance, including potential ...

6. cfhlstatewidetraining.org cfhlstatewidetraining.org/podcast/s3e6-nutrition-interventions-people-living-hiv

S3E6: Nutrition Interventions for People Living with HIV The study looks at how a monthly curated food box affects insulin resistance and inflammation in people living with HIV over a three month ...

7. jpmph.org jpmph.org/journal/view.php?number=2349

Food is Medicine Initiative for Mitigating Food Insecurity in ... The FIM program includes medically tailored meals, medically tailored groceries, and produce prescriptions. Data suggest that it has lowered ...