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Polyphenol-rich Preparation
BDPP Supplement Metabolism Study in Healthy Individuals
Phase 1
Recruiting
Led By James Murrough, MD, PhD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female aged 18-55 years
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 5
Awards & highlights
Study Summary
This trial will study the effects of a dietary supplement on the body. The supplement is a mixture of Concord grape juice, grape seed extract, and resveratrol.
Who is the study for?
This trial is for healthy men and women aged 18-55 with a BMI under 30, who understand English well enough to consent to study procedures. It's not for those pregnant or nursing, with psychiatric diagnoses, unstable medical conditions, using certain supplements or medications affecting polyphenol levels or inflammation.Check my eligibility
What is being tested?
The study tests the effects of a Bioactive Dietary Polyphenol Preparation (BDPP) made from Concord grape juice, grape seed extract, and trans-resveratrol compared to a placebo. The focus is on how these substances are processed in the body.See study design
What are the potential side effects?
Since this trial involves healthy volunteers and bioactive compounds found in common foods like grapes, side effects might be minimal but could include mild digestive discomfort or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 55 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 5
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
DHCA level
Secondary outcome measures
IL-6 levels
Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: High Dose BDPPActive Control3 Interventions
24 oz. Concord grape juice + 1200mg Grape seed polyphenol extract + 450mg Trans-resveratrol
Group II: Medium Dose BDPPActive Control3 Interventions
16 oz. Concord grape juice + 900 mg Grape seed polyphenol extract + 300 mg Trans-resveratrol
Group III: Low Dose BDPPActive Control3 Interventions
8 oz. Concord grape juice + 450 mg Grape seed polyphenol extract + 150 mg Trans-resveratrol
Group IV: PlaceboPlacebo Group1 Intervention
Comparable placebos
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
861 Previous Clinical Trials
525,188 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
832 Previous Clinical Trials
668,885 Total Patients Enrolled
1 Trials studying Healthy Controls
73 Patients Enrolled for Healthy Controls
James Murrough, MD, PhD4.04 ReviewsPrincipal Investigator - Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
5 Previous Clinical Trials
286 Total Patients Enrolled
5Patient Review
Dr. Murrough is always willing to listen, and I appreciate his thoroughness and expertise. I've been with him for several years now, and he has always been sensitive to my needs.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 55 years old.I am not taking any anti-inflammatory drugs or supplements.I am not pregnant, nursing, or planning to become pregnant.I do not have any major health issues found in lab tests, physical exams, or heart checks.I have been diagnosed with a psychiatric condition as per DSM-5.I do not have any unstable illnesses affecting my organs or immune system.I have an inflammatory or autoimmune condition like lupus or rheumatoid arthritis.I am between 18 and 55 years old.
Research Study Groups:
This trial has the following groups:- Group 1: High Dose BDPP
- Group 2: Medium Dose BDPP
- Group 3: Placebo
- Group 4: Low Dose BDPP
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research involve individuals over the age of 45?
"This study allows patients that are between 18-55 years old to participate."
Answered by AI
What are the government's thoughts on High Dose BDPP?
"High Dose BDPP is still being tested for safety in Phase 1 trials, so it received a score of 1."
Answered by AI
Which type of patient would best be helped by participating in this clinical trial?
"88 individuals, both male and female, who are aged 18-55 years old and have a BMI under 30 are eligible for this trial. Participants must also be healthy controls."
Answered by AI
Who else is applying?
What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Icahn School of Medicine at Mount Sinai
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
All trials are important and to find a cure or a treatment to help our future generation.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
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