Active — Not RecruitingNot Applicable

Metabolism and Absorption of Anthocyanins From Extract and Whole Blueberry Powder Confections in Healthy Adults

United States12 participantsStarted 2018-05-08

Plain-language summary

This trial studies how well a group of compounds found in blueberries called anthocyanins are absorbed into the body from 2 different types of blueberry confections (blueberry extract and whole blueberry powder). Blueberries contain several compounds which may be beneficial for human health and prevention of disease. These compounds can be consumed as part of a complex matrix in the whole fruit or also in a simplified matrix in the form of a fruit extract. Studying the absorption and metabolism of these compounds may help researchers understand how they influence health and disease, as well as determining the role of the food matrix on absorption of berry phytochemical.

Who can participate

Age range

18 Years – 65 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: * Be healthy, free-living adults * Have a body mass index (BMI) between 18 and 35 kg/m\^2 * Be a non-smoker (defined as adults who have never smoked or who have not had a cigarette in the past ten years) * Agree to follow a berry-restricted diet and to document any accidental consumption of restricted foods each day of the study Exclusion Criteria: * Report being actively treated for any metabolic, digestive or immunologic disorder including malabsorptive disorders, renal insufficiency, hepatic insufficiency, any autoimmune disorder or short bowel syndrome * Have a known allergy or food intolerance to ingredients in study products (blueberries), other berries, wheat, or soy * Are strict vegans (no consumption of animal, fish or egg products) * Are planning to conceive, or are currently pregnant or lactating * Are heavy alcohol consumers (defined as an average consumption of greater than 2 drinks/ day) * Have been on an antibiotic regime lasting for one week in the last 6 months

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

Acceptability

Timeframe: Day 0 of each arm

Acceptability

Timeframe: Day 8 of each arm

Bioavailability of the various berry interventions

Timeframe: Day 1 of each arm

Bioavailability of the various berry interventions

Timeframe: Day 8 of each arm

Trial details

NCT IDNCT04329962

SponsorOhio State University Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-05-14

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