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

NCT04329962 | Active Not Recruiting

• 2 other identifiers: OSU-18010NCI-2020-01525
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Diet; Nutrition Aspect of Cancer

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Group I (blueberry extract, blueberry powder)

EXPERIMENTAL

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; Other: Dietary Intervention; Other: Questionnaire Administration

Group II (blueberry powder, blueberry extract)

EXPERIMENTAL

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; Other: Dietary Intervention; Other: Questionnaire Administration

Interventions

Blueberry Powder Food Product OTHER

Consume blueberry powder confection

Group I (blueberry extract, blueberry powder); Group II (blueberry powder, blueberry extract)

Dietary Intervention OTHER

Consume blueberry extract confection

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Group I (blueberry extract, blueberry powder); Group II (blueberry powder, blueberry extract)

Questionnaire Administration OTHER

Ancillary studies

Group I (blueberry extract, blueberry powder); Group II (blueberry powder, blueberry extract)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Yael Vodovotz

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: April 1, 2020
• Study Start: May 8, 2018
• Primary Completion: May 14, 2018
• Study Completion (Estimated): July 10, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)