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

NCT ID: NCT04329962

Last Updated: 2025-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-08

Study Completion Date

2026-07-10

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVES:

I. Compare urinary flavonoids composition, compliance and sensory acceptability of 2 blueberry-based amorphous functional confections one containing blueberry extract and the other of a whole blueberry powder) formulated to deliver the 320 mg of anthocyanins.

II. Assess the effect of blueberry source (extract versus \[vs\] whole fruit powder) on urinary metabolomics profile.

OUTLINE: Participants are randomized to of 2 groups.

GROUP I: Participants undergo a washout on days -7 to -1 and then consume blueberry extract confection on day 0. Participants undergo a second washout on days 1-7 and then consume blueberry powder confection on day 8.

GROUP II. Participants undergo a washout on days -7 to -1 and then consume blueberry powder confection on day 0. Participants undergo a second washout on days 1-7 and then consume blueberry extract confection on day 8.

Conditions

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Healthy Diet Nutrition Aspect of Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group I (blueberry extract, blueberry powder)

Participants undergo a washout on days -7 to -1 and then consume blueberry extract confection on day 0. Participants undergo a second washout on days 1-7 and then consume blueberry powder confection on day 8.

Group Type EXPERIMENTAL

Blueberry Powder Food Product

Intervention Type OTHER

Consume blueberry powder confection

Dietary Intervention

Intervention Type OTHER

Consume blueberry extract confection

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Group II (blueberry powder, blueberry extract)

Participants undergo a washout on days -7 to -1 and then consume blueberry powder confection on day 0. Participants undergo a second washout on days 1-7 and then consume blueberry extract confection on day 8.

Group Type EXPERIMENTAL

Blueberry Powder Food Product

Intervention Type OTHER

Consume blueberry powder confection

Dietary Intervention

Intervention Type OTHER

Consume blueberry extract confection

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Blueberry Powder Food Product

Consume blueberry powder confection

Intervention Type OTHER

Dietary Intervention

Consume blueberry extract confection

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Dietary Modification intervention, dietary Nutrition Intervention Nutrition Interventions Nutritional Interventions

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Yael Vodovotz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yael Vodovotz

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

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Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2020-01525

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-18010

Identifier Type: -

Identifier Source: org_study_id

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