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

Healthy Diet Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04329962
• Other study ID #: OSU-18010
• Secondary ID: NCI-2020-01525P3
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 8, 2018
• Est. completion date: July 10, 2024

Study information

• Verified date: January 2024
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Healthy Diet
• Nutrition Aspect of Cancer

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 (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	National Cancer Institute (NCI)

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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