Nutrition to Optimize, Understand, and Restore Insulin Sensitivity in HIV for Oklahoma

HIV Clinical Trial

— NOURISH-OK  

Official title:

Nutrition to Optimize, Understand, and Restore Insulin Sensitivity in HIV for Oklahoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05208671
• Other study ID #: 12509
• Secondary ID: 5R01DK127464
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2020
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: University of Oklahoma
• Contact: Lacey Caywood, MPH
• Phone: 918-834-4194
• Email: nourish[@]tulsacares.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The NOURISH-OK Study will identify how food insecurity contributes to insulin resistance, an important surrogate marker of many co-morbidities in HIV disease, using an integrated framework to identify key leverage points for insulin resistance. Drawing from these pathways, this study will adapt and evaluate a community-driven, science-informed "food as medicine" intervention designed to lower insulin resistance through healthy food access, food utilization skills, and other self-care behaviors. Knowledge gained from this study can benefit those living with HIV through the prevention and more effective management of pre-diabetes, diabetes, obesity, and non-alcoholic fatty liver disease.

Description:

The community-based participatory research study will be conducted in Oklahoma, and include HIV-positive individuals living in urban and rural communities. The first two aims are observational, the third aim will test an intervention.

Aim 1: Test and refine a conceptual integrated framework of food insecurity and insulin resistance to identify significant structural, social, behavioral, and biological pathways as candidate intervention points. This aim will be accomplished using a cross-sectional survey (n=410 final sample size) and a one-month observational sub-study from the main study sample (n=89 final sample size) to collect intensive measures of dietary intake and gut microbiome samples.

Aim 2: Adapt a home-delivered grocery and cooking self-care NOURISH-OK intervention to address key nutrition disparities and other health risk behaviors identified as significant path contributors to insulin resistance among people living with HIV. This aim will be achieved through a series of interviews and focus groups with people living with HIV who are food insecure (n=45 qualitative study subjects, including interviews and focus groups).

Aim 3: Implement the 12-week NOURISH-OK intervention and assess it for feasibility, acceptability, and preliminary impact using a randomized wait-list control design (n=234). This study will use a simple randomized wait-list control trial design. Additionally, the investigators will invite a random selection from the main study sample (n=80) to participate in more intensive data collection, including multiple 24-hr food recalls and stool samples during the intervention period to assess for food insecurity, dietary, and gut microbiome changes throughout the intervention periods.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 234
• Est. completion date: December 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV-positive with income <400% federal poverty level

• at least 1 risk factor for insulin resistance per the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (i.e., overweight/obesity, age 45 yrs or older, immediate family member with diabetes, non-white race, physical inactivity, history of gestational diabetes, history of heart disease or stroke, diagnosis of polycystic ovarian syndrome, high blood pressure, high cholesterol, or hepatitis C virus antibody positivity

• using antiretroviral therapy for at least 6 months

• English-speaking

Exclusion Criteria:

• participating in another health-related research study

• receiving treatment for a terminal or other serious illness, such as cancer or end-stage renal failure

• plan to move outside of Oklahoma during the study period

• does not have an address that can accept home-delivered groceries

Related Conditions & MeSH terms

• Food Insecurity
• HIV
• Insulin Resistance

Intervention

Other:
• NOURISH Food Box
Selection of healthy groceries designed to reduce chronic inflammation and improve insulin resistance with healthy cooking/self-care curriculum

Locations

Country	Name	City	State
United States	OU Integrative Immunology Center	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline gut microbiome composition at 12-weeks	Microbiome composition (diversity) - subsample only	Baseline; 12-weeks
Primary	Change from baseline insulin sensitivity at 12-weeks	Quantitative Insulin-Sensitivity Check Index (QUICKI)	Baseline; 12-weeks
Secondary	Change from baseline food security at 6-weeks, 12-weeks, and 16-weeks	10-item US Adult Food Security Module (0-10 point range; higher score reflects lower food security)	Baseline; 6-weeks; 12-weeks; 16-weeks
Secondary	Change from baseline dietary intake at 6-weeks, 12-weeks, and 16-weeks	Dietary Inflammatory Index (DII) (higher score reflects diet with greater inflammatory potential)	Baseline; 6-weeks; 12-weeks; 16-weeks
Secondary	Change from baseline skin carotenoid at 12-weeks	reflection spectroscopy using "Veggie Meter" device (higher score reflects higher carotenoid status)	Baseline; 12-weeks
Secondary	Change from baseline chronic inflammation at 12-weeks	C-reactive protein (blood measure) (higher score reflects higher chronic inflammation)	Baseline; 12-weeks

External Links

•   NOURISH-OK Study Information Webpage