Influence of Peanut Consumption on Cardiovascular Risk Factors and the Gut Microbiome: A Randomized Clinical Trial
- Conditions
- Cardiovascular risk biomarkers and gut microbiome
- Registration Number
- ITMCTR2024000050
- Lead Sponsor
- Division of Epidemiology, Vanderebilt University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
100 participants (50 each arm)
1.Age: 40 – 70, FOBT negative
2.Do not consume peanut or other tree nuts/seeds more than 1 time per week.
3.Self-reported diabetes/prediabetes but not on diabetes medication
4.Or self-reported dyslipidemia but not on lipid or triglyceride lowing medication
5.Or BMI>=25 or waist circumference >90 cm for man or >80 cm for women
6.Or systolic/diastolic blood pressure = 130/85 mmHg
Individuals meet any of the following conditions are not eligible for the study
1.Known and suspected peanut/peanut containing products allergy
2.Kidney disease
3.Liver disease
4.Cardiovascular disease
5.Myocardial infarction
6.Cancer
7.Stroke
8.Drink more than 2 units of alcohol (2 cups of wine, 2 shuts of liquid or 2 cans of beer) weekly
9.On diabetes medications currently or during past 3 months
10.On lipid or triglyceride lowing medications currently or during past 3 months
11.Hospitalized in the past three months
12.Received chemotherapy, immune suppressive treatment, antibiotics during last 3 months
13.Have gained or lost more than 2.5 kg of weight in the last 3 months
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method rinary metabolites;HbA1C;Gut microbiome profile;Plasma CRP;Lipid profile;Plasma insulin;Glucose;
- Secondary Outcome Measures
Name Time Method