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Polyphenols
Flavonoid-Rich Foods for Human Health
N/A
Waitlist Available
Led By Shengmin Sang, PhD
Research Sponsored by North Carolina Agriculture & Technical State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-2 hours, 2-4 hours, 4-6 hours,6-8 hours, 8-12 hours, 12-24 hours post-dose
Awards & highlights
Study Summary
This trial studies how dietary flavonoids affect the body when consumed, looking at soymilk, green tea, and blueberries.
Who is the study for?
This trial is for healthy adults aged 25-70 with a BMI of 18-30. Participants should be nonsmokers, drink less than 3-4 times per week without recent alcohol intake, and have no history of significant exposure to industrial waste. They must not have allergies to soy milk, be free from antibiotics or prescription drugs for six months, and avoid flavonoid supplements.Check my eligibility
What is being tested?
The study tests how the body processes compounds called reactive carbonyl species after taking a single dose of dietary flavonoids found in soymilk, green tea, or blueberries compared to a control group. It aims to understand the formation and movement of these compounds within the human body.See study design
What are the potential side effects?
Since this trial involves common foods like soymilk, green tea, and blueberries as interventions rather than pharmaceuticals, side effects are expected to be minimal but could include potential allergic reactions or gastrointestinal discomfort.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-2 hours, 2-4 hours, 4-6 hours,6-8 hours, 8-12 hours, 12-24 hours post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-2 hours, 2-4 hours, 4-6 hours,6-8 hours, 8-12 hours, 12-24 hours post-dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in levels of reactive carbonyl species (RCS) adducts of soymilk, green tea, or blueberry polyphenols in feces over 48 hours after one single dose of soymilk, green tea, or consumption.
Change in plasma levels of reactive carbonyl species (RCS) adducts of soymilk, green tea, or blueberry polyphenols over 24 hours after one single dose of soymilk, green tea, or consumption.
Change in urinary levels of reactive carbonyl species (RCS) adducts of soymilk, green tea, or blueberry polyphenols over 24 hours after one single dose of soymilk, green tea, or consumption.
Secondary outcome measures
Change in plasma levels of RCS over 24 hours after one single dose of soymilk, green tea, or blueberry consumption
Change in urinary levels of RCS over 24 hours after one single dose of soymilk, green tea, or blueberry consumption
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dietary flavonoids (soymilk, green tea, or blueberry) consumptionExperimental Treatment1 Intervention
Each subject takes breakfast with 460 ml of soymilk, green tea, or blueberry in a single dose, and samples (plasma, urine, and stool samples) at different time points were collected following the administrations of soymilk, green tea, or blueberry blend.
Group II: Control groupPlacebo Group1 Intervention
Each subject takes breakfast with 460 ml of milk or water in a single dose, and samples (plasma, urine, and stool samples) at different time points were collected following the administration of milk or water.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Soymilk, green tea, or blueberry
2023
N/A
~20
Find a Location
Who is running the clinical trial?
North Carolina Agriculture & Technical State UniversityLead Sponsor
8 Previous Clinical Trials
160 Total Patients Enrolled
2 Trials studying Polyphenols
25 Patients Enrolled for Polyphenols
Shengmin Sang, PhDPrincipal InvestigatorNC A&T State University
2 Previous Clinical Trials
25 Total Patients Enrolled
2 Trials studying Polyphenols
25 Patients Enrolled for Polyphenols
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have cancer.I have been cancer-free and off medication for over 2 years.I am not on any prescription medications.I haven't consumed alcohol in the last three weeks.I am not taking any medications.I am between 25 and 70 years old.I have a condition like gout, heart disease, or diabetes.I have not consumed alcohol in the last 3 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Dietary flavonoids (soymilk, green tea, or blueberry) consumption
- Group 2: Control group
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.
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