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

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04329962
Collaborator
National Cancer Institute (NCI) (NIH)
12
Enrollment
1
Location
2
Arms
55.8
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Blueberry Powder Food Product
  • Other: Dietary Intervention
  • Other: Questionnaire Administration
 N/A

Detailed Description

PRIMARY OBJECTIVES:

  1. 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.

  2. 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 Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Comparison of Bioavailability and Urinary Metabolite Profile After Consumption of Blueberry Extract and Whole Blueberry Powder Confections in Healthy Men and Women
Actual Study Start Date :
May 8, 2018
Actual Primary Completion Date :
May 14, 2018
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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: 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

    • Other: Questionnaire Administration
    Ancillary studies
    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: 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

    • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Acceptability [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.

    2. Acceptability [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.

    3. Bioavailability of the various berry interventions [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.

    4. Bioavailability of the various berry interventions [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Ohio State University Comprehensive Cancer Center
    • National Cancer Institute (NCI)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Yael Vodovotz, Principal Investigator, Ohio State University Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04329962
    Other Study ID Numbers:
    • OSU-18010
    • NCI-2020-01525
    • P30CA016058
    First Posted:
    Apr 1, 2020
    Last Update Posted:
    Sep 24, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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

    Study Results

    No Results Posted as of Sep 24, 2021