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New treatment option for Arterial Stiffness
Official title Prebiotic Effects of California Grapes on Gut Health and Cardiometabolic Health in Overweight Men and Women
ClinicalTrials.gov ID: NCT06544954
What this study is testing
- What it's testing
- The goal of this clinical trial is to assess the impact of table grape consumption on gut microbiome, intestinal permeability, systemic inflammation, and vascular function in healthy overweight men and women aged 45-70 years. The main questions it aims to answer are: Does daily grape intake alter intestinal microbiome composition and intestinal permeability?
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 70. Healthy volunteers may be eligible.
You may be able to join if
- post-menopausal women (cessation of menstruation for minimum two years)
- overweight and obese (BMI between 25-35 kg/m2)
- stable treatment for type 2 diabetes or metabolic syndrome
- ability to understand the intervention concept and written consent to participate
- willingness to accept randomization, undergo testing and intervention procedures, and deliver stool and blood samples
You likely can't join if
- menopausal hormone replacement therapy started within less than 6 months
- antibiotics, prebiotics within last 3 months
- antidiabetic treatment involving insulin (for type 1 diabetes)
- vegetarian/vegan and not able to follow modified diet
- any serious medical condition including but not limited to coronary artery disease, uncontrolled hypertension, stroke, congestive heart failure...
- psychiatric disease that interferes with the understanding and implementation of the intervention
See the full eligibility criteria
- post-menopausal women (cessation of menstruation for minimum two years)
- overweight and obese (BMI between 25-35 kg/m2)
- stable treatment for type 2 diabetes or metabolic syndrome
- ability to understand the intervention concept and written consent to participate
- willingness to accept randomization, undergo testing and intervention procedures, and deliver stool and blood samples
- menopausal hormone replacement therapy started within less than 6 months
- antibiotics, prebiotics within last 3 months
- antidiabetic treatment involving insulin (for type 1 diabetes)
- vegetarian/vegan and not able to follow modified diet
- any serious medical condition including but not limited to coronary artery disease, uncontrolled hypertension, stroke, congestive heart failure, insulin-dependent diabetes, liver disease, active cancer and anemia
- psychiatric disease that interferes with the understanding and implementation of the intervention
- history of eating disorders such as bulimia nervosa, anorexia nervosa, severe binge eating disorder in the last 5 years
- history of substance abuse or alcohol abuse
- involvement in a weight loss intervention program (including anti-obesity medication) within last 3 months or have had bariatric surgery
- current smokers (within last 180 days)
- use of dietary supplements containing polyphenols in the past 1 month
- strenuous exercise greater than 10 hours per week
The study team makes the final eligibility decision.
Where it's taking place
- Davis, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Davis, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.