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

NCT05208671 | Completed DMC

• 2 other identifiers: 125095R01DK127464
• Study Type: interventional
• Target: 675
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV; Food Insecurity; Insulin Resistance

Keywords

food as medicine; nutrition

Outcome Measures

Primary Outcomes (1)

• Change from baseline insulin sensitivity at 12-weeks

  Quantitative Insulin-Sensitivity Check Index (QUICKI)

  Baseline; 12-weeks

Secondary Outcomes (4)

• Change from baseline food security at 6-weeks, 12-weeks, and 16-weeks

  Baseline; 6-weeks; 12-weeks; 16-weeks

• Change from baseline dietary intake at 6-weeks, 12-weeks, and 16-weeks

  Baseline; 6-weeks; 12-weeks; 16-weeks

• Change from baseline skin carotenoid at 12-weeks

  Baseline; 12-weeks

• Change from baseline chronic inflammation at 12-weeks

  Baseline; 12-weeks

Other Outcomes (1)

• Change from baseline gut microbiome composition at 12-weeks

  Baseline; 12-weeks

Study Arms (2)

NOURISH Food Box

EXPERIMENTAL

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

Other: NOURISH Food Box

Wait-list Control

NO INTERVENTION

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

Interventions

NOURISH Food Box OTHER

Selection of healthy groceries designed to reduce chronic inflammation and improve insulin resistance with healthy cooking/self-care curriculum

NOURISH Food Box

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

OU Integrative Immunology Center

Tulsa, Oklahoma, 74135, United States

Location

Related Publications (1)

• Wetherill MS, Bakhsh C, Caywood L, Williams MB, Hartwell ML, Wheeler DL, Hubach RD, Teague TK, Kohler G, Hebert JR, Weiser SD. Unpacking determinants and consequences of food insecurity for insulin resistance among people living with HIV: Conceptual framework and protocol for the NOURISH-OK study. Front Clin Diabetes Healthc. 2022;3:947552. doi: 10.3389/fcdhc.2022.947552. Epub 2022 Aug 16.

  PMID: 36225538 DERIVED

Related Links

• NOURISH-OK Study Information Webpage

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Marianna S Wetherill, PhD, MPH, RD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 26, 2022
• Study Start: October 9, 2020
• Primary Completion: October 30, 2025
• Study Completion: November 17, 2025
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Made available within 12 months of study end.
• Access Criteria: Written request to PI.

Locations

US (1)