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Dietary Oxysterols and β-Cell Function Among African Americans

NCT05072587 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-04-17

No results posted yet for this study

Summary

African Americans (AAs) have a higher risk of developing type 2 diabetes than the general population. AAs are also more likely to eat foods that contain cholesterol oxides/oxysterols.

Dietary oxysterols can harm the cells that produce insulin and decrease insulin production.

This pilot study seeks to determine if removing dietary oxysterols with a plant-based diet will improve insulin production and decrease the risk of type 2 diabetes among AAs.

Conditions

Interventions

BEHAVIORAL

Plant-based diet with no oxysterols

This group will be given prepared plant-based meals that exclude all cholesterol oxides/oxysterols, adhere to the ADA guidelines, and meet specified daily calorie levels based on age and sex. Macronutrient levels for the diet will fall within the Acceptable Macronutrient Distribution Range for fat (20-35%), protein (10-35%), and carbohydrate (45-65%). The goal is weight maintenance, but weight loss may occur. A 1-5% weight loss will be acceptable and not deemed a potential confounder. Participants will be screened for food allergies and intolerances prior to receiving their research diets. All meals will include culturally familiar foods to enhance adherence. The dietary intervention will be conducted over an 8-week period. Meals will be packaged labeled and distributed to participants once per week. Participants will consume their meals at home.

BEHAVIORAL

Standard ADA Diet (SADA)

This group will be given prepared meals that adhere to the ADA guidelines and meet specified daily calorie levels based on age and sex. Macronutrient levels for the diet will fall within the Acceptable Macronutrient Distribution Range for fat (20-35%), protein (10-35%), and carbohydrate (45-65%). The goal is weight maintenance, but weight loss may occur. A 1-5% weight loss will be acceptable and not deemed a potential confounder. Participants will be screened for food allergies and intolerances prior to receiving their research diets. All meals will include culturally familiar foods to enhance adherence. The dietary intervention will be conducted over an 8-week period. Meals will be packaged labeled and distributed to participants once per week. Participants will consume their meals at home.

Sponsors & Collaborators

  • Emory University

    collaborator OTHER

  • Morehouse School of Medicine

    lead OTHER

Principal Investigators

  • Jennifer Rooke, MD, MPH · Morehouse School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05072587 on ClinicalTrials.gov