Comparison of Bioavailability and Urinary Metabolite Profile After Consumption of Blueberry Extract and Whole Blueberry Powder Confections in Healthy Men and Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Acceptability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group I (blueberry extract, blueberry powder)
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.
干预措施: Blueberry Powder Food Product (Other)
Group I (blueberry extract, blueberry powder)
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.
干预措施: Dietary Intervention (Other)
Group I (blueberry extract, blueberry powder)
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.
干预措施: Questionnaire Administration (Other)
Group II (blueberry powder, blueberry extract)
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.
干预措施: Blueberry Powder Food Product (Other)
Group II (blueberry powder, blueberry extract)
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.
干预措施: Dietary Intervention (Other)
Group II (blueberry powder, blueberry extract)
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.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Acceptability
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Yael Vodovotz
Principal Investigator
Ohio State University Comprehensive Cancer Center