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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04329962
Other study ID # OSU-18010
Secondary ID NCI-2020-01525
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 8, 2018
Est. completion date July 10, 2024

Study information

Verified date May 2024
Source Ohio State University Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 12
Est. completion date July 10, 2024
Est. primary completion date May 14, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Blueberry Powder Food Product
Consume blueberry powder confection
Dietary Intervention
Consume blueberry extract confection
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acceptability 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
Primary Acceptability 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
Primary Bioavailability of the various berry interventions 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
Primary Bioavailability of the various berry interventions 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
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