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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy Diet, Nutrition Aspect of Cancer

Intervention / Treatment
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* Other: Blueberry Powder Food Product
* Other: Dietary Intervention
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (blueberry extract, blueberry powder)<br>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<br>* Consume blueberry powder confection<br>Other: Dietary Intervention<br>* Consume blueberry extract confection<br>* Other names: Nutritional Interventions;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Group II (blueberry powder, blueberry extract)<br>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<br>* Consume blueberry powder confection<br>Other: Dietary Intervention<br>* Consume blueberry extract confection<br>* Other names: Nutritional Interventions;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |