Clinical trial NCT05072587: Dietary Oxysterols and β-Cell Function Among African Americans
Official title: Dietary Oxysterols and β-Cell Function Among African Americans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Beta-cell dysfunction oxysterols African Americans
Lead sponsor: Morehouse School of Medicine
Sponsor class: OTHER
Collaborators: name: Emory University
First posted: 2021-10-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This pilot study is a longitudinal prospective randomized clinical trial with two parallel arms. Participants in both arms of the study will receive prepared meals based on ADA dietary guidelines for 12 weeks. One group will be given a plant-based ADA diet that contains no oxysterols (PB-ADAØ). The other group will be given the Standard ADA diet (SADA). 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Homeostasis Model Assessment of β-cell function (HOMA-B) Index
timeFrame: 12 Weeks
measure: Glycated Hemoglobin (HbA1c)
timeFrame: 12 weeksC-peptide levels are elevated in renal failure It is produced in equim C
measure: Serum 7-Ketocholesterol (7-KC)
timeFrame: 12 weeks
Secondary outcomes:
measure: The Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Index
timeFrame: 12 Weeks
measure: Fasting Insulin
timeFrame: 12 weeks
measure: Fasting C-Peptide
timeFrame: 12 weeks
measure: Fasting Blood Glucose
timeFrame: 12 weeks
measure: Total cholesterol (TC)
timeFrame: 12 weeks
measure: High Density Lipoproteins (HDL)
timeFrame: 12 weeks
measure: Low Density Lipoproteins (LDL)
timeFrame: 12 weeks
measure: Oxided Low Density Lipoproteins (Ox-LDL)
timeFrame: 12 weeks
measure: Aspartate Amino Transferase (AST)
timeFrame: 12 weeks
measure: Alanine Amino Transferase (ALT)
timeFrame: 12 weeks
measure: Glomerular Filtration Rate (GFR)
timeFrame: 12 weeks
measure: Blood Urea Nitrogen (BUN)
timeFrame: 12 weeks
measure: Creatinine
timeFrame: 12 weeks
measure: White Blood Cell (WBC) Count
timeFrame: 12 weeks
measure: Hemoglobin (Hb)
timeFrame: 12 weeks
measure: Platelet Count
timeFrame: 12 weeks
measure: Calcium
timeFrame: 12 weeks
measure: Vitamin B12
timeFrame: 12 weeks
measure: Blood pressure (BP)
timeFrame: 12 weeks
measure: Body composition using the Dual X-ray Absorptiometry (DEXA) Body Composition scan
timeFrame: 12 weeks
measure: Body Mass Index (BMI)
timeFrame: 12 weeks
measure: Waist circumference (WC)
timeFrame: 12 weeks
measure: World Health Organization (WHO-5) Index of Well Being
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Morehouse School of Medicine
state: Georgia
Study officials:
affiliation: Morehouse School of Medicine
name: Jennifer Rooke
role: PRINCIPAL_INVESTIGATOR
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