Dietary Oxysterols and β-Cell Function Among African Americans

NCT05072587 | Completed DMC

• 1 other identifier: MorehouseSM
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Type 2 Diabetes

Keywords

Beta-cell dysfunction oxysterols African Americans

Outcome Measures

Primary Outcomes (3)

• The Homeostasis Model Assessment of β-cell function (HOMA-B) Index

  The HOMA-B index will be calculated using the HOMA2 Calculator with fasting C-peptide and fasting blood glucose levels. This study will compare the effect of the standard American Diabetes Association (ADA) diet that contains oxysterols and a plant-based ADA diet that does not contain oxysterols on the HOMA-B index of African Americans (AAs) with prediabetes and early diabetes.

  8 Weeks

• Glycated Hemoglobin (HbA1c)

  HbA1c is a measure of glycemic control. This study will compare the effect of the standard ADA diet that contains oxysterols and a plant-based ADA diet without oxysterols on the HbA1c of AAs with HbA1c levels between 5.7% and 7.0%.

  8 weeks C-peptide levels are elevated in renal failure It is produced in equim C

• Serum 7-Ketocholesterol (7-KC)

  7-KC is one of the most abundant oxysterols in food and serum. This study will compare the effect of a standard ADA diet with oxysterols and a plant-based ADA diet without oxysterols on serum 7-KC levels. 7-KC will be measured by tandem liquid chromatography /mass spectrometry at the Emory Lipidomics lab.

  8 weeks

Secondary Outcomes (23)

• The Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Index

  8 Weeks

• Fasting Insulin

  8 weeks

• Fasting C-Peptide

  8 weeks

• Fasting Blood Glucose

  8 weeks

• Total cholesterol (TC)

  8 weeks

Study Arms (2)

Group A - Standard ADA dietary guidelines (SADA)

ACTIVE COMPARATOR

Participants in this group will be given prepared meals based on standard ADA dietary guidelines for 8 weeks.

Behavioral: Standard ADA Diet (SADA)

Group B - Plant Based ADA diet with no oxysterols (PB-ADAØ).

EXPERIMENTAL

Participants in this group will be given prepared meals based on ADA guidelines but with no dietary cholesterol oxides/oxysterols - Plant-based ADA diet

Behavioral: Plant-based diet with no oxysterols

Interventions

Plant-based diet with no oxysterols BEHAVIORAL

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.

Also known as: Cholesterol Oxide-free plant-based diet

Group B - Plant Based ADA diet with no oxysterols (PB-ADAØ).

Standard ADA Diet (SADA) BEHAVIORAL

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.

Also known as: ADA Diet

Group A - Standard ADA dietary guidelines (SADA)

Eligibility Criteria

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

You may qualify if:

• HbA1c: 5.7% - 7.0%: This HbA1c range reflects mild to moderate β-cell dysfunction.
• Self-identified AA: This group has higher rates of T2D than the general population.
• Adults over18 years old: This age group is at higher risk of T2D.
• Ability to read, understand and communicate effectively in English: All information about the study and instructions for the study protocol will be in English.
• Committed to eating the allocated study diet for 12 weeks: This is important to ensure that the study protocol is followed, and the data collected from participants is meaningful/valid.
• On stable medication dosages for the three months prior to recruitment: This is to avoid bias or confounding with new medications or dosages changes.
• Able to safely store a week's supply of prepared meals: Participants will receive packages of prepared food that has to stored and last them for the following week.
• Mentally competent and able to follow the study protocol and provide informed consent
• Currently eating the Standard American diet: The baseline diet of the participants will be assessed and correlated their baseline serum 7-KC levels and HOMA2 Index of β-cell function.

You may not qualify if:

• Be pregnant or lactating: Fetuses and breast-feeding infants are a protected vulnerable group. The risk of involving them in research must outweigh the benefits, Hormonal levels and other factors in pregnant and lactating woman may confound study results.
• Be taking statin medications or any other cholesterol lowering drugs or supplements: These medications may artificially lower serum cholesterol and oxysterol levels.
• Be currently on a vegan, vegetarian, or any type of plant-based diet for the 3 months prior to recruitment: Participants currently on these diets may not see significant changes on the dietary interventions of the study protocol.
• Be a current smoker: Smoking is a risk factor for oxidative stress - this could be an effect modifier or a confounding faction for this study.
• Be on medications or supplements to lower blood glucose or treat diabetes: This will be an effect modifier or confounding factor. We will not know the effect of the dietary intervention if the participants are also on medications for diabetes.
• Be status post blood transfusion in the previous 3 months: This will interfere with the test for HbA1c levels. This is one of our primary outcomes:
• Have a hemoglobin or any other blood disorder: This will interfere with the test for HBA1c which measures glycation of hemoglobin in red blood cells.:
• Be taking biotin supplements: This interferes with the test for fasting C-Peptide.
• Be on dialysis or have any stage of renal failure: Dialysis patients need special diets and more intense monitoring than is planned for the participants in this study.
• Have food allergies: Participants will be screened for food allergies. This is to prevent food sensitivities or adverse reactions to the prepared meals in the study.

Sponsors & Collaborators

• Morehouse School of Medicine: lead
• Emory University: collaborator

Study Sites (1)

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

Location

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet, Plant-Based

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jennifer Rooke, MD, MPH

  Morehouse School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This pilot study is a randomized clinical trial with a counterbalanced, cross-over design. Participants will be randomized to receive isocaloric diets comprised of either a Standard ADA diet (SADA) or a plant-based ADA diet that contains no oxysterols (PB-ADAØ) for the first 8-week dietary intervention period. Participants will resume self-selected diets for an 8-week washout period and then receive the alternate diet treatment for another 8-week dietary intervention period. The order of dietary periods will be counterbalanced so that half of the participants receive the SADA first while the other half receive the PB-ADAØ first. The dietary 7-KC content of both diets will be estimated from oxysterol food composition databases. Sample meals from both groups will be analyzed to determine the 7-KC food content and the accuracy of the estimates.

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: October 11, 2021
• Study Start: July 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)