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

January 22, 2024 updated by: Yael Vodovotz, Ohio State University Comprehensive Cancer Center

Comparison of Bioavailability and Urinary Metabolite Profile After Consumption of Blueberry Extract and Whole Blueberry Powder Confections in Healthy Men and Women

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Questionnaire Administration
Ancillary studies
Other: Blueberry Powder Food Product
Consume blueberry powder confection
Other: Dietary Intervention
Consume blueberry extract confection
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions
Experimental: 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.
Other: Questionnaire Administration
Ancillary studies
Other: Blueberry Powder Food Product
Consume blueberry powder confection
Other: Dietary Intervention
Consume blueberry extract confection
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: Day 0 of each arm
Means +/- SD (standard deviation) will be used to express the results from acceptability tests, and differences in acceptability of the two confections will be determined using paired t tests using the SPSS statistical software package.
Day 0 of each arm
Acceptability
Time Frame: Day 8 of each arm
Means +/- SD (standard deviation) will be used to express the results from acceptability tests, and differences in acceptability of the two confections will be determined using paired t tests using the SPSS statistical software package.
Day 8 of each arm
Bioavailability of the various berry interventions
Time Frame: Day 1 of each arm
Will measure bioavailability of the various berry interventions using high performance liquid chromatography (HPLC) analysis of blueberry phytochemicals and metabolites in urine at the day 1 timepoint, after consumption of the test product. Baseline comparisons for anthocyanins found in urine between trials will be performed a paired t-test. Total anthocyanins in 24-hour urine after consumption of one blueberry treatment will be compared to each participant's baseline urine and to total anthocyanins after consumption of the blueberry treatment in a paired t-test.
Day 1 of each arm
Bioavailability of the various berry interventions
Time Frame: Day 8 of each arm
Will measure bioavailability of the various berry interventions using high performance liquid chromatography (HPLC) analysis of blueberry phytochemicals and metabolites in urine at the day 8 timepoints. Baseline comparisons for anthocyanins found in urine between trials will be performed a paired t-test. Total anthocyanins in 24-hour urine after consumption of one blueberry treatment will be compared to each participant's baseline urine and to total anthocyanins after consumption of the blueberry treatment in a paired t-test.
Day 8 of each arm

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Yael Vodovotz, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2018

Primary Completion (Actual)

May 14, 2018

Study Completion (Estimated)

July 10, 2024

Study Registration Dates

First Submitted

March 25, 2020

First Submitted That Met QC Criteria

March 31, 2020

First Posted (Actual)

April 1, 2020

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • OSU-18010
  • P30CA016058 (U.S. NIH Grant/Contract)
  • NCI-2020-01525 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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