Effect of Daily Consumption of Peanuts on Immune Function and Cardiometabolic Markers and Risk Factors in Free-living Individuals: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- changes in percentage body fat
研究概览
简要总结
The aim of the proposed study is two-fold: to determine whether the intake of peanuts (a) enhances immune function and (b) produces a desirable impact on selected cardiometabolic biomarkers and risk factors.
详细描述
The aim of the proposed study is two-fold: to determine whether the intake of peanuts (a) enhances immune function and (b) produces a desirable impact on selected cardiometabolic biomarkers and risk factors . To accomplish this objective, a human dietary intervention trial (RCT) with peanuts is proposed. The proposed study is a 12-week parallel-group, free-living, observer-blind, randomized controlled dietary intervention trial. This study will examine the effects of peanuts on markers of immune function, cardiometabolic markers and risk factors and upper respiratory tract infections, in 80 adult male and female volunteers.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adults between the ages of 18-70 years
排除标准
- •known intolerance or allergy to peanuts
- •bad dentures unable to chew peanuts
- •regular intake of peanuts and/or other nuts (>3 ounces/week)
- •use of immune-boosting supplements
- •exposure to antibiotics and corticoids immediately prior to the study
- •use of other medications or supplements that can interfere with the immune functions
- •Individuals that received any vaccination (i.e flu or Covid 19) 6 months prior to the start of the study
研究组 & 干预措施
Peanut group
Participants will be consuming 2 ounces of peanuts /peanut butter everyday for 12 weeks
干预措施: Peanut intake (Other)
control group
Participants will continue with habitual diet and abstain from eating peanuts
结局指标
主要结局
changes in percentage body fat
时间窗: baseline to 12 weeks
A change in the percentage of body fat for both the peanut and control group will be measured using an In Body machine at the baseline and end of intervention
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 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 and IFN-γ, MCP1, Eotaxin, E-selectin, RANTES and Pentraxin-3
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 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 the serum lipid concentration
时间窗: baseline to 12 weeks
This is a composite measurement which will measure the changes in the levels of serum low density cholesterol, high density cholesterol, non- high density cholesterol and triglycerides
Changes in insulin resistance
时间窗: baseline to 12 weeks
Change in insulin resistance will be measured using the Hemostatic Model Assessment calculator version 2 (HOMA2-IR)
Changes in Hemoglobin A1c
时间窗: baseline to 12 weeks
Change in Hemoglobin A1c will be measured by cation-exchange high-performance liquid chromatography method
Changes in body weight
时间窗: baseline to 12 weeks
A change in body weight for both the peanut and control group will be measured using an In Body machine at the baseline and end of intervention
changes in systolic and diastolic blood pressure
时间窗: baseline to 12 weeks
Seated systolic and diastolic blood pressure will be measured at baseline and end of intervention utilizing Omron -Model HEM-7471 C device. Three measurements will be taken after a five-minute rest period, 1 minute apart, and the last two recordings will be averaged for analysis.
次要结局
- changes in upper respiratory infection questionnaire score(baseline to 12 weeks)
研究者
Joan Sabate,DrPH, MD
Professor
Loma Linda University