Healthy Diet, Nutrition Aspect of Cancer
Conditions
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.
Interventions
OTHERBlueberry Powder Food Product
Consume blueberry powder confection
OTHERDietary Intervention
Consume blueberry extract confection
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | Day 0 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 1 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 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORYael Vodovotz
Ohio State University Comprehensive Cancer Center
Outcome results
None listed