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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 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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-2 hours, 2-4 hours, 4-6 hours,6-8 hours, 8-12 hours, 12-24 hours post-dose for reporting.

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

Soymilk, green tea, or blueberry (Polyphenols) Clinical Trial Eligibility Overview. Trial Name: NCT05773794 — N/A
Polyphenols Research Study Groups: Dietary flavonoids (soymilk, green tea, or blueberry) consumption, Control group
Polyphenols Clinical Trial 2023: Soymilk, green tea, or blueberry Highlights & Side Effects. Trial Name: NCT05773794 — N/A
Soymilk, green tea, or blueberry (Polyphenols) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05773794 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it permissible for persons of advanced age to partake in this research endeavor?

"According to the criteria for entry, participants must be aged 25 and above but not exceed 70 years old."

Answered by AI

Am I eligible to join in this investigation?

"The eligibility requirements for this trial necessitate that potential participants possess polyphenols and fall in the age range of 25-70. Thus far, 16 individuals have been enrolled."

Answered by AI

Could eligible participants still sign up for this ongoing clinical trial?

"The trial is recruiting patients as of the present moment. It was initially posted on February 6th 2023, and modified most recently on March 6th 2023 according to clinicaltrials.gov"

Answered by AI

How many people have enrolled in this trial thus far?

"Affirmative. According to clinicaltrials.gov, this study is actively seeking participants and has been since February 6th 2023; the posting was last edited on March 6th of the same year. The research seeks 16 individuals from one specific site for enrolment."

Answered by AI

Who else is applying?

What site did they apply to?
North Carolina Agriculture and Technical State University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Scavenging of Reactive Carbonyl Species by Dietary Flavonoids in Humans
Shengmin Sang 2023. "Scavenging of Reactive Carbonyl Species by Dietary Flavonoids in Humans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05773794.
~7 spots leftby Apr 2025
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