Clinical trial NCT04329962: Metabolism and Absorption of Anthocyanins from Extract and Whole Blueberry Powder Confections in Healthy Adults
Official title: Comparison of Bioavailability and Urinary Metabolite Profile After Consumption of Blueberry Extract and Whole Blueberry Powder Confections in Healthy Men and Women
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Diet
Nutrition Aspect of Cancer
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability
timeFrame: Day 0 of each arm
measure: Acceptability
timeFrame: Day 8 of each arm
measure: Bioavailability of the various berry interventions
timeFrame: Day 1 of each arm
measure: Bioavailability of the various berry interventions
timeFrame: Day 8 of each arm
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Yael Vodovotz
role: PRINCIPAL_INVESTIGATOR
References: