Gut Microbiome Clinical Trial
— CHSOfficial title:
Evaluating the Effects of Corn Flour Consumption on Cardio-metabolic Outcomes and the Gut Microbiome in Adults With High Cholesterol
Verified date | February 2024 |
Source | Arizona State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to investigate the effects of 3 different corn flours: (1) whole grain corn flour, (2) 50% refined corn flour + 50% corn bran derived from whole corn meal, and (3) refined corn flour, on cardio-metabolic outcomes and changes in the gut microbiome.
Status | Completed |
Enrollment | 58 |
Est. completion date | October 30, 2023 |
Est. primary completion date | August 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Healthy English and Spanish speaking males and females with elevated circulating cholesterol levels (LDL-c = 120 mg/dL). - Individuals with LDL-c > 190 mg/dL will be permitted to participate but must provide a letter from their doctor stating that they are comfortable with their participation in the study. Exclusion Criteria: - recent weight fluctuations (> 5 lb in past 3 months), following specialized or restrictive diets (e.g. carbohydrate restriction, veganism) - use of supplements (antioxidants, fiber, botanicals) - allergies to dairy, egg, wheat, corn or gluten - use of antibiotics in the past 2-3 months - use of lipid lowering medications - regular physical activity = 30 min/d for = 5 days/wk - history of thyroid disorders, diabetes, heart disease, cancer, hepatitis, inflammatory conditions and/or gastrointestinal disorders which may impact gut function and metabolism - anyone with a fear of needles or blood draws - If female, women may not be pregnant or lactating during the study. - Unwillingness to comply with study protocols will also result in exclusion from the study. - Participants in this study will not be eligible if they are participating in other research studies at the same time. |
Country | Name | City | State |
---|---|---|---|
United States | Arizona Biomedical Collaborative | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Arizona State University | North American Millers Association - Corn Division |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | LDL Cholesterol | Serum LDL cholesterol concentrations will be measured at the 0 and 4 weeks for each cornmeal intervention | 0 weeks, 4 weeks | |
Primary | HDL Cholesterol | Serum HDL cholesterol concentrations will be measured at the 0 and 4 weeks for each cornmeal intervention | 0 weeks, 4 weeks | |
Secondary | Gut Microbiome Diversity | Fecal gut microbiome communities will be sequenced using microbial DNA extracted from samples at 0 and 4 weeks for each cornmeal intervention. Amplified copies of the 16S rRNA gene will be evaluated for treatment differences in alpha (within-sample richness and evenness) and beta diversity (between-sample community structure). Relative and differential abundance of individual microbial taxa will also be measured. | 0 weeks, 4 weeks |
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