Immune and Cognitive Benefits of Mango Intake in Young Adults: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Changes in Lymphocyte activity
研究概览
简要总结
The main objectives of our proposed study are to determine the effects of mango consumption on immune and cognitive functions in free-living college going young adults aged 18-30 years
详细描述
The main objectives of our proposed study are to determine the effects of mango consumption on immune and cognitive functions in free-living college going young adults aged 18-30. To accomplish these objectives, a randomized controlled, parallel design study is proposed with two groups consuming their habitual diet, but with one (Mango group) receiving 1.5 servings of mango/day and the other (Control group) abstaining from eating any mango for the duration of the study.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The investigator and outcome assessor will not be aware of which participant is in which arm
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female college students aged 18-30 years
排除标准
- •known intolerance or allergy to mangos
- •regular intake of mangos and/or fruits of a similar nutritional content such as peach, nectarine, papaya, apricot and cantaloupe
- •using cognition and/or immune-boosting supplements or vitamins
- •recent exposure to antibiotics and corticoids
- •uncontrolled chronic diseases and mental illnesses, clinical depression, and immunocompromised state
研究组 & 干预措施
Mango Group
Participants in the Mango group will consume 1.5 cups of mangos for 12 weeks
干预措施: Mango group (Dietary Supplement)
control group
The control group will receive no dietary intervention. they will follow usual diet and abstain from eating mangos
结局指标
主要结局
Changes in Lymphocyte activity
时间窗: baseline to 12 weeks
The production of lymphocytes will be measured in the supernatant using enzyme linked immunosorbent assay (ELISA)
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, Naive and memory cells and B cells
Changes in cytokine production
时间窗: baseline to 12 weeks
The cytokines produced due to lymphocyte activity will be measured in the supernatant using enzyme linked immunosorbent assay (ELISA)
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) will include hs-CRP, interleukin (IL)-1B, IL-6, TNF a, IL-10, IL-2, IFN-γ, E-selectin,
changes from baseline in global cognitive composite score
时间窗: baseline to 12 weeks
The composite score will be calculated using the scores from the tests listed below. Scores will be calculated with the standardized scores of each test as the score of each participant minus the group mean and divide by its standard deviation. The composite score is the mean of the standardized scores. the 5 tests are: Rey Auditory Verbal Learning Test (RAVLT), Brief Visuospatial Memory Test, Digit Span, FAS Word Fluency, Symbol Digit Modalities Test
Change in serum brain-derived neurotrophic factor (pg/mL)
时间窗: baseline to 12 weeks
changes in serum brain-derived neurotrophic factor (pg/mL) assessed by ELISA
次要结局
未报告次要终点