Dietary oxysterols linked to diabetes risk in african americans
NCT ID NCT05072587
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study looked at whether removing oxysterols (harmful compounds in cooked animal foods) from the diet could improve insulin production in African Americans with prediabetes or early type 2 diabetes. Twelve participants ate a plant-based diet free of oxysterols for a period. Researchers measured changes in insulin function and blood sugar control. The goal was to see if this diet could lower diabetes risk in a high-risk group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Plant-based diet without oxysterols
- What this could lead to
- If this diet improves insulin production, it could point toward a dietary approach to lower type 2 diabetes risk in African Americans.
- What could go wrong
- This was a very small pilot study (12 people) with no control group, so results may not apply broadly. Dietary changes can be hard to maintain long-term.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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12 people
The number who actually took part.
- Started
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Jul 2021
- Finished
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Dec 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Participants must be: 1. HbA1c: 5.7% - 7.0%: This HbA1c range reflects mild to moderate β-cell dysfunction. 2. Self-identified AA: This group has higher rates of T2D than the general population. 3. Adults over18 years old: This age group is at higher risk of T2D. 4. Ability to read, understand and communicate effectively in English: All information about the study and instructions for the study protocol will be in English. 5. 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. 6. On stable medication dosages for the three months prior to recruitment: This is to avoid bias or confounding with new medications or dosages changes. 7. 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. 8. Mentally competent and able to follow the study protocol and provide informed consent 9. 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. Exclusion Criteria: Participants cannot: 1. 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. 2. Be taking statin medications or any other cholesterol lowering drugs or supplements: These medications may artificially lower serum cholesterol and oxysterol levels. 3. 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. 4. 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. 5. 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. 6. 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: 7. 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.: 8. Be taking biotin supplements: This interferes with the test for fasting C-Peptide. 9. 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. 10. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Morehouse School of Medicine
Atlanta, Georgia, 30310, United States
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