No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
45 – 70
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
40 (estimated)
Sponsor
University of California, Davis · Other
Who this trial is looking for
This trial is looking for overweight men and women aged 45-70. Participants will take grape powder twice a day for three weeks to see how it affects gut and heart health.
Are You a Good Fit for This Trial?
Rules you outType 1 diabetesActive cancerEating disorders
You may be able to join if
I am a post-menopausal woman
I am overweight or obese
I have stable type 2 diabetes or metabolic syndrome
I can understand and agree to participate
I am willing to follow the study procedures
I can provide stool and blood samples
You may not be able to join if
I have started menopause hormone therapy in the last 6 months
I have taken antibiotics or prebiotics in the last 3 months
I take insulin for diabetes
I am vegetarian or vegan and cannot follow the modified diet
I have any serious medical condition like heart disease or cancer
I have a psychiatric condition affecting my understanding of the study
I have had an eating disorder in the last 5 years
I smoke or have smoked in the last 180 days
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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?
* Are changes in gut microbiota and …
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?
* Are changes in gut microbiota and intestinal permeability correlated with changes in cardiometabolic risk factors (inflammation, vascular function, lipid profiles)?
* Does response to grape intake on gut microbiota, intestinal permeability, cardiometabolic and inflammatory markers differ between men and women?
* Are metabolic pathways modified by grape consumption able to explain the link between gut health and cardiometabolic factors?
Researchers will compare freeze-dried grape powder to placebo powder to see if grape powder improves cardiometabolic risk factors.
Participants will
* Consume the powder dissolved in water twice daily for 3 weeks
* Follow their usual diet, modified to limit polyphenol-rich foods
* Visit the clinic at the beginning and end of the intervention for vascular measurements and blood sample collection
* Complete a 3-day 24-hour dietary recall and collect stool sample before each visit
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion 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
* willingne…
Inclusion 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
Exclusion Criteria:
* 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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.