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Type 2 DiabetesNCT05072587

Dietary Oxysterols and β-Cell Function Among African Americans

A study testing Plant-based diet with no oxysterols and Standard ADA Diet (SADA) in people with Type 2 Diabetes, run by Morehouse School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Plant-based diet with no oxysterols and Standard ADA Diet (SADA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
1 Jul 2021to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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:
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Morehouse School of Medicine

    Atlanta, Georgia, 30310

Other trials in United States

About this study

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.

Read the detailed description

African Americans (AAs) have almost twice the incidence and prevalence of Type 2 diabetes (T2D) compared to the general population. T2D occurs when pancreatic β-cell dysfunction prevents secretion of sufficient insulin to overcome insulin resistance. While the causes of β-cell dysfunction are not fully understood, the role of cytotoxic oxidative stress is well documented. Serum oxysterols are biomarkers of oxidative stress. Oxysterols form endogenously or exogenously when cholesterol in food is exposed to light, heat, and processing. Dietary oxysterols are cytotoxic, they are absorbed and carried in the blood by lipoprotein carriers or circulate freely in serum. 7-Ketocholesterol (7-KC), the most common oxysterol in food and serum is a biomarker of cholesterol oxidation. High serum levels of 7-KC are associated with an increased risk of T2D. AAs who consume Southern dietary pattern foods such as fried and processed meats have a higher consumption of dietary oxysterols than the general population. Our central hypothesis is that the higher consumption of dietary oxysterols among AAs contributes to β-cell dysfunction and higher rates of T2D. The aim of this pilot study is to determine the effect of lowering dietary oxysterols on serum 7-KC and β-cell function among AAs with prediabetes and early T2D (HbA1c 5.7% - 7.0%). The expected outcome is that decreased exposure to dietary oxysterols will decrease serum oxysterols and β-cells oxidative stress which will improve β-cell function and glycemic control. The knowledge gained from this study may lead to improved T2D prevention and treatment strategies that may decrease the burden of T2D in all communities and eliminate the racial disparity among AAs.

Conditions
Type 2 Diabetes
Being tested
Plant-based diet with no oxysterols, Standard ADA Diet (SADA)
Keywords
Beta-cell dysfunction oxysterols African Americans
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Plant-based diet with no oxysterolsBehavioural

    Also called Cholesterol Oxide-free plant-based diet

    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.

  • Standard ADA Diet (SADA)Behavioural

    Also called ADA Diet

    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.

Study groups in NCT05072587
Study groupRoleWhat they receive
Group A - Standard ADA dietary guidelines (SADA)Active comparatorParticipants in this group will be given prepared meals based on standard ADA dietary guidelines for 8 weeks.
Receives: Behavioral: Standard ADA Diet (SADA)
Group B - Plant Based ADA diet with no oxysterols (PB-ADAØ).ExperimentalParticipants in this group will be given prepared meals based on ADA guidelines but with no dietary cholesterol oxides/oxysterols - Plant-based ADA diet
Receives: Behavioral: Plant-based diet with no oxysterols

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 8 Weeks

  2. 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%.

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

  3. 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.

    Measured: 8 weeks

Secondary outcomes (23)

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

    This index will be calculated using the HOMA2 Calculator with fasting insulin and fasting blood glucose levels. The impact of the 2 different study diets on the HOMA-IR will be determined.

    Measured: 8 Weeks

  2. Fasting Insulin

    Insulin is a hormone produced by beta cells in the pancreas, it regulates serum glucose levels. The impact of the 2 different study diets on fasting insulin will be determined.

    Measured: 8 weeks

  3. Fasting C-Peptide

    C-peptide is a short chain of amino acids that is released as a byproduct of insulin production. It is produced in equimolar amounts as endogenous insulin but excreted at a more constant rate over a longer time. It is a sensitive, clinically validated assessment of of β-cell function. This study will measure the effect of the 2 study diets on fasting C-peptide.

    Measured: 8 weeks

  4. Fasting Blood Glucose

    Glucose is the main sugar found in blood. Elevated fasting blood glucose is a sign of diabetes. This study will measure the effects of the 2 study diets on fasting blood glucose.

    Measured: 8 weeks

  5. Total cholesterol (TC)

    TC is a measure of the total amount of cholesterol in blood. This study will determine the effect of the 2 study diets on serum TC levels.

    Measured: 8 weeks

  6. High Density Lipoproteins (HDL)

    HDL is the lipoprotein carrier that carries cholesterol from the cell to the liver to be excreted. This study will measure the effect of the 2 study diets on serum HDL levels.

    Measured: 8 weeks

  7. Low Density Lipoproteins (LDL)

    LDL is the liproprotein carrier that carries cholesterol from the liver to the cells of the body. This study will measure the effect of the 2 study diets on serum LDL levels.

    Measured: 8 weeks

  8. Oxided Low Density Lipoproteins (Ox-LDL)

    Ox-LDL form when LDLs carry cholesterol oxides/oxysterols. Ox-LDLs are cytotoxic and better indicators of cardiovascular risk than native LDL levels. This study will measure the effect of the 2 study diets on serum LDL levels.

    Measured: 8 weeks

  9. Aspartate Amino Transferase (AST)

    AST is an enzyme that is released from the liver when it is injured. It is an indicator of liver function. This study will measure the effect of the 2 study diets on AST levels.

    Measured: 8 weeks

  10. Alanine Amino Transferase (ALT)

    ALT is an enzyme that is released from the liver when it is injured. It is an indicator of liver function. This study will measure the effect of the 2 study diets on ALT levels.

    Measured: 8 weeks

  11. Glomerular Filtration Rate (GFR)

    GFR is an index of kidney function. This study will measure the effect of the 2 study diets on GFR. In addition, it is important to measure kidney function in this study because C-peptide levels are elevated in renal failure

    Measured: 8 weeks

  12. Blood Urea Nitrogen (BUN)

    BUN is a breakdown product of protein that is cleared from the blood by the kidneys. It is an indicator of kidney function. This study will measure the effect of the 2 study diets on BUN.

    Measured: 8 weeks

  13. Creatinine

    Creatinine is a by-product of normal muscle breakdown that is cleared from the blood by the kidneys. It is an indicator of kidney function. This study will measure the effect of the 2 study diets on serum creatinine levels.

    Measured: 8 weeks

  14. White Blood Cell (WBC) Count

    The WBC count is a measure of the number of WBCs the body. WBCs are immune cells and markers of inflammation. This study will measure the effect of the 2 study diets on WBC counts.

    Measured: 8 weeks

  15. Hemoglobin (Hb)

    Hb is a protein in red blood cells that carries oxygen from the lungs to the body. This study will measure the effect of the 2 study diets on Hb levels. In addition, it is important to know Hb levels because Hb abnormalities affect HbA1c levels.

    Measured: 8 weeks

  16. Platelet Count

    The platelet count is the number of platelets in blood. Platelets are involved in clotting, which is dysfunctional in diabetes. This study will measure the effect of the 2 study diets on platelet counts.

    Measured: 8 weeks

  17. Calcium

    This is measure of serum calcium levels. A plant-based diet may cause low calcium levels. This study will measure the effect of the 2 study diets on serum calcium levels.

    Measured: 8 weeks

  18. Vitamin B12

    This is a measure of vitamin B-12 levels. People on plant-based diets may have lower vitamin B12 levels. This study will measure the effect of the 2 study diets on vitWBC amin B12 levels.

    Measured: 8 weeks

  19. Blood pressure (BP)

    BP is the pressure of circulating blood against the walls of blood vessels. It is an indicator of cardiovascular health. It will be measured at baseline, 6-weeks and post intervention. This study will measure the effect of the 2 study diets on BP.

    Measured: 8 weeks

  20. Body composition using the Dual X-ray Absorptiometry (DEXA) Body Composition scan

    The DEXA scan provides an analysis of body fat, muscle mass and bone density. This study will measure the effect of the 2 study diets on body composition.

    Measured: 8 weeks

  21. Body Mass Index (BMI)

    BMI is defined as the body weight divided by the square of the body height. This is expressed in units of kg/m². It will be used to classify study particpants according to body mass into underweight, normal, overweight or obese groups. This study will measure the effect of the 2 study diets on BMI.

    Measured: 8 weeks

  22. Waist circumference (WC)

    WC is the measurement taken around the abdomen at the level of the umbilicus (belly button). This measures abdominal obesity which may be a better indicator of health risk than BMI. This study will measure the effect of the 2 study diets on WC.

    Measured: 8 weeks

  23. World Health Organization (WHO-5) Index of Well Being

    The WHO-5 Well-Being Index is a short self-reported measure of current mental wellbeing. This study will measure the effect of the 2 study diets on this indicator of well being.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2021
  2. Study start1 Jul 2021
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05072587
Sponsor's protocol ID
MorehouseSM
Status last verified
Apr 2026
First submitted
24 Sep 2021
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No individual participant data will be shared.

Publications

  • Diabetes and African Americans, CDC 2016. Summary Health Statistics: National Health Interview Survey: 2014. US Department of Health and Human Services, Office of Minority Health website. http://www.cdc.gov/nchs/nhis/shs/tables.htm

  • Benoit SR, Hora I, Albright AL, Gregg EW. New directions in incidence and prevalence of diagnosed diabetes in the USA. BMJ Open Diabetes Res Care. 2019 May 28;7(1):e000657. doi: 10.1136/bmjdrc-2019-000657. eCollection 2019.

    PubMed 31245008

  • Staimez LR, Rhee MK, Deng Y, Safo SE, Butler SM, Legvold BT, Jackson SL, Ford CN, Wilson PWF, Long Q, Phillips LS. Retinopathy develops at similar glucose levels but higher HbA1c levels in people with black African ancestry compared to white European ancestry: evidence for the need to individualize HbA1c interpretation. Diabet Med. 2020 Jun;37(6):1049-1057. doi: 10.1111/dme.14289. Epub 2020 Apr 25.

    PubMed 32125000

  • Chen C, Cohrs CM, Stertmann J, Bozsak R, Speier S. Human beta cell mass and function in diabetes: Recent advances in knowledge and technologies to understand disease pathogenesis. Mol Metab. 2017 Jul 8;6(9):943-957. doi: 10.1016/j.molmet.2017.06.019. eCollection 2017 Sep.

    PubMed 28951820

  • Boughton CK, Munro N, Whyte M. Targeting beta-cell preservation in the management of type 2 diabetes. British Journal of Diabetes and Vascular Disease. Published online 2017. doi:10.15277/bjd.2017.148

  • Butler AE, Janson J, Bonner-Weir S, Ritzel R, Rizza RA, Butler PC. Beta-cell deficit and increased beta-cell apoptosis in humans with type 2 diabetes. Diabetes. 2003 Jan;52(1):102-10. doi: 10.2337/diabetes.52.1.102.

    PubMed 12502499

  • Saisho Y. Importance of Beta Cell Function for the Treatment of Type 2 Diabetes. J Clin Med. 2014 Aug 14;3(3):923-43. doi: 10.3390/jcm3030923.

    PubMed 26237486

  • Saisho Y. An emerging new concept for the management of type 2 diabetes with a paradigm shift from the glucose-centric to beta cell-centric concept of diabetes - an Asian perspective. Expert Opin Pharmacother. 2020 Sep;21(13):1565-1578. doi: 10.1080/14656566.2020.1776262. Epub 2020 Jun 10.

    PubMed 32521177

  • RISE Consortium. Lack of Durable Improvements in beta-Cell Function Following Withdrawal of Pharmacological Interventions in Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes. Diabetes Care. 2019 Sep;42(9):1742-1751. doi: 10.2337/dc19-0556. Epub 2019 Jun 9.

    PubMed 31178434

  • Standl E. The importance of beta-cell management in type 2 diabetes. Int J Clin Pract Suppl. 2007 Jun;(153):10-9. doi: 10.1111/j.1742-1241.2007.01360.x.

    PubMed 17594389

  • Kahleova H, Tura A, Hill M, Holubkov R, Barnard ND. A Plant-Based Dietary Intervention Improves Beta-Cell Function and Insulin Resistance in Overweight Adults: A 16-Week Randomized Clinical Trial. Nutrients. 2018 Feb 9;10(2):189. doi: 10.3390/nu10020189.

    PubMed 29425120

  • Zhyzhneuskaya SV, Al-Mrabeh A, Peters C, Barnes A, Aribisala B, Hollingsworth KG, McConnachie A, Sattar N, Lean MEJ, Taylor R. Time Course of Normalization of Functional beta-Cell Capacity in the Diabetes Remission Clinical Trial After Weight Loss in Type 2 Diabetes. Diabetes Care. 2020 Apr;43(4):813-820. doi: 10.2337/dc19-0371. Epub 2020 Feb 14.

    PubMed 32060017

  • Lean MEJ, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Welsh P, Kean S, Ford I, McConnachie A, Messow CM, Sattar N, Taylor R. Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial. Lancet Diabetes Endocrinol. 2019 May;7(5):344-355. doi: 10.1016/S2213-8587(19)30068-3. Epub 2019 Mar 6.

    PubMed 30852132

  • Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.

    PubMed 11832527

  • Davis BC, Jamshed H, Peterson CM, Sabate J, Harris RD, Koratkar R, Spence JW, Kelly JH Jr. An Intensive Lifestyle Intervention to Treat Type 2 Diabetes in the Republic of the Marshall Islands: Protocol for a Randomized Controlled Trial. Front Nutr. 2019 Jun 5;6:79. doi: 10.3389/fnut.2019.00079. eCollection 2019.

    PubMed 31231656

Questions about this trial

What is this clinical trial studying?

A study testing Plant-based diet with no oxysterols and Standard ADA Diet (SADA) in people with Type 2 Diabetes, run by Morehouse School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Homeostasis Model Assessment of β-cell function (HOMA-B) Index (time frame: 8 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05072587, which also lists 46 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.

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