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

The Ohio State University

Status: Active, not recruiting

Conditions: Healthy Diet; Nutrition Aspect of Cancer

Treatments: Other: Dietary Intervention; Other: Questionnaire Administration; Other: Blueberry Powder Food Product

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04329962

NCI-2020-01525 (Registry Identifier)

OSU-18010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Group I (blueberry extract, blueberry powder)

Experimental group

Description:

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.

Treatment:

Other: Blueberry Powder Food Product

Other: Questionnaire Administration

Other: Dietary Intervention

Group II (blueberry powder, blueberry extract)

Experimental group

Description:

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.

Treatment:

Other: Blueberry Powder Food Product

Other: Questionnaire Administration

Other: Dietary Intervention