Effect of Daily Consumption of Almonds on Immune Strength and Response to Flu Vaccination in Overweight Middle -Aged Men: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- changes in lymphocyte populations
研究概览
简要总结
This research study will test the effects of almonds on immune functions and immune response to influenza vaccine in overweight middle-aged men and postmenopausal women
详细描述
The proposed study is a parallel-group, free-living, observer-blind, randomized controlled dietary intervention trial on 66 overweight middle-aged men and post menopausal women. This study will be carried out in two phases: Phase 1 will examine the effects of almonds on clinically relevant markers of immune function, and Phase 2 will assess the antibody response to influenza vaccination following almond consumption. Participants will attend a baseline clinic and will be randomized to one of two groups. The Almond group will receive 15% of daily energy intake in the form of almonds as a snack and the Control group will continue thier usual diet but completely avoid almonds and restrict other nuts to less than 2 servings per week. The intervention will be for 12 weeks, at which time both group participants will receive the influenza vaccination, and continue the same dietary intervention for another 28 weeks.
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 which participant is in what arm. The participant and the care provider will know about the treatment allocation
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight men and post menopausal women (Basal Metabolic Index 25-32)
- •Age limit between 40-70 years
- •Be able to commute to Loma Linda University
排除标准
- •Intolerance or allergy to almonds
- •Bad dentures, inability to chew almonds
- •Regular intake of almonds and or other nuts
- •Use of immune boosting supplements
- •Exposure to antibiotics and corticosteroids immediately prior to study
- •Have received influenza vaccination in past 10 months
- •Uncontrolled chronic disease and psychiatric illness
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 lymphocyte activity and 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
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 lymphocyte activity and 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
- changes in upper respiratory infection questionnaire score(baseline to 28 weeks)
- changes in upper respiratory infection questionnaire score(baseline to 28 weeks)
- changes in blood zinc levels(baseline to 12 weeks)
研究者
Joan Sabate,DrPH, MD
Professor of Nutrition
Loma Linda University