Impact of Protein Source and Polyphenol Complexation in Protein Bars on Metabolic Health (NCT07489118) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Impact of Protein Source and Polyphenol Complexation in Protein Bars on Metabolic Health
United States72 participantsStarted 2025-05-01
Plain-language summary
The goal of this clinical trial is to learn if pulse (pea) protein works similar to animal (whey) protein in protein bars consumed by healthy adults.
The main questions it aims to answer are: What are the differences in taste and tolerance profiles between pea and whey proteins? What metabolic and immune changes do participants experience while eating them? What gastrointestinal microbiome shifts can be observed in these participants? How incorporation and complexation of polyphenols with these proteins changes the study outcomes?
Participants will: Consume 1 protein bar with whey protein, pea protein, pea protein with complexed polyphenols, or pea protein with free polyphenols every day for 2 months. Visit the study site at baseline and end of study for checkups and tests. Fill dietary, food acceptance, gastrointestinal tolerance, and global health questionnaires.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* both men and women between the ages of 18-64 years;
* body mass index of 25 and higher;
* generally healthy and without a clinically significant condition (diabetes, infectious disease, or cancer);
* participants must not be pregnant or nursing;
* participants must not be a tobacco user; and
* history of allergies or intolerance to protein bar ingredients.
Exclusion Criteria:
* body mass index lower than 25;
* pregnancy or nursing;
* use of blood sugar lowering medications such as metformin, semaglutide, or insulin;
* use of dietary supplements with polyphenols;
* history of allergies or intolerance to protein bar ingredients;
* noncompliance with the study protocol.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Taste
Timeframe: At baseline and after 2 months (end of study)
2
Gastrointestinal tolerance
Timeframe: At baseline and after 2 months (end of study)