Metabolism and Absorption of Anthocyanins from Extract and Whole Blueberry Powder Confections in Healthy Adults
- Conditions
- Healthy DietNutrition Aspect of Cancer
- Interventions
- Other: Blueberry Powder Food ProductOther: Dietary InterventionOther: Questionnaire Administration
- Registration Number
- NCT04329962
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 12
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group I (blueberry extract, blueberry powder) Blueberry Powder Food Product 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 I (blueberry extract, blueberry powder) Dietary Intervention 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 I (blueberry extract, blueberry powder) Questionnaire Administration 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 (blueberry powder, blueberry extract) Questionnaire Administration 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. Group II (blueberry powder, blueberry extract) Blueberry Powder Food Product 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. Group II (blueberry powder, blueberry extract) Dietary Intervention 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.
- Primary Outcome Measures
Name Time Method Acceptability Day 8 of each arm 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.
Bioavailability of the various berry interventions Day 8 of each arm 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States