Immune Benefits of Blueberry Consumption in Overweight Older Men and Postmenopausal Women: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- changes in lymphocyte populations
研究概览
简要总结
This research study will test the effects of Blueberries on immune functions in overweight older men and postmenopausal women
详细描述
This study will examine the effects of Blueberries on clinically relevant markers of immune function. Eligible and selected participants will be randomized to one of two groups at the baseline clinic visit. The Blueberry group participants will consume blueberries (2 packets of blueberry freeze-dried powder equivalent to 2 cups of fresh blueberries) added to the habitual diet and the Control group participants will abstain from blueberries (with instructions to limit the consumption of other berries and polyphenol rich foods) but otherwise continue their habitual diet. During the study, clinic visits will occur at 4-week intervals (baseline, weeks 4, 8 and 12) for a total of 4 visits at the Loma Linda University Nutrition Research Center. Blood samples taken at baseline and at week 12 will be assayed for changes in immune function and inflammatory markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The investigator, participant, care provider, outcomes assessor will not be aware of which participant is in which arm
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Older men and post-menopausal women aged 50-70 year
- •Have BMI of 25-32
- •Able to commute to Loma Linda University
- •Consuming a typical American Diet low in polyphenols
排除标准
- •Intolerance or allergy to Blueberries
- •Regular intake of Blueberries and other berried (>2 ounces/week)
- •Immune system insufficiency or disease
- •Using immune boosting supplements
- •Exposure to antibiotics and corticoids immediately prior to study
- •Uncontrolled chronic diseases and relevant psychiatric illness, including major depression
- •Flu vaccination and or Covid Vaccination less than 3 months ago from the start of the study
研究组 & 干预措施
Blueberry powder group
Participants in the blueberry powder group will receive freeze dried blueberries in form of a powder
干预措施: Blueberry powder group (Dietary Supplement)
Blueberry powder group
Participants in the blueberry powder group will receive freeze dried blueberries in form of a powder
干预措施: Placebo powder group (Dietary Supplement)
Placebo powder group
Participants in the placebo group will receive an isocaloric placebo powder.
干预措施: Placebo powder group (Dietary Supplement)
Placebo powder group
Participants in the placebo group will receive an isocaloric placebo powder.
干预措施: Blueberry powder group (Dietary Supplement)
结局指标
主要结局
changes in lymphocyte populations
时间窗: baseline to 12 weeks
Immunophenotyping will be performed by flow cytometry to measure the number of T helper, T cytotoxic, Naïve and memory cells and B cells
changes in cytokine production
时间窗: baseline to 12 weeks
PBMC cells will be separated from blood, activated and cultured using phytohemagglutinin (PHA). Inflammatory cytokine production will be measured in the resulting supernatant using ELISA
changes in natural killer (NK) cell activity
时间窗: baseline to 12 weeks
The NK degranulation assay will be performed on blood samples. The test will be conducted using a modified flow cytometry method that measures the expression of CD107a
changes in serum inflammatory cytokine concentration
时间窗: baseline to 12 weeks
Changes in the concentrations of the inflammatory cytokines will be performed on serum using enzyme-linked immunoassay (ELISA)
changes in complete blood count (CBC)
时间窗: baseline to 12 weeks
changes in the complete blood count will be performed on whole blood with the use of an automated hematology analyzer at a certified clinical facility
次要结局
未报告次要终点