Effects of Almonds on Immune Health and Responsiveness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in immune and inflammatory markers
研究概览
简要总结
This study has the primary objective of investigating the benefits of consuming whole almonds on immune health and immune response in adults with obesity.
详细描述
The study is a six week, randomized, controlled, and parallel arm clinical trial in which participants will be randomized to consume either 57 grams of whole almonds daily or to consume an isocaloric cookie snack daily. Outcomes assessed will include blood and adipose immune markers, cardiometabolic biomarkers, and gut microbiome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI): 30-45 kg/m^2
- •Willingness to consume study foods
- •Willing to comply with study protocol
- •Consistent diet and activity patterns for 4 weeks
- •Weight stable (no greater than 5 kg change over the last 3 months)
- •Non-smoker > 1 year or more
排除标准
- •Regular consumer of nuts
- •Planning on getting viral vaccines during study
- •Allergies to study foods (almonds, cookies)
- •Illicit drug use
- •Recent start of medications that affect metabolism or appetite
- •Current use of medication that interfere with immune measures
- •Drug therapy for coronary artery disease, peripheral artery disease, congestive heart failure, or dyslipidemia
- •Pregnant of lactating individuals
- •Lidocaine allergies
研究组 & 干预措施
Almond
Participants in this group will be instructed to consume 57 grams of whole almonds every day for six weeks.
干预措施: Almond supplementation (Other)
Cookie
Participants in this group will be instructed to consume cookies equivalent to the energy content of 57 grams of whole almonds every day for six weeks.
干预措施: Cookie supplementation (Other)
结局指标
主要结局
Change in immune and inflammatory markers
时间窗: Over 6 weeks
Lymphocytes, granulocytes, monocytes, interleukins, cytokines, etc.
Change in immune cell profile
时间窗: Over 6 weeks
Immunophenotyping
次要结局
- Transcriptomics profiles(Baseline, week 6)
- Acceptance rating of foods(Baseline, week 3, week 6)
- Glucoregulation(Baseline and week 6)
- 24 hour appetite ratings(Baseline, week 6)
- Anthropometrics(Baseline, week 3, and week 6)
- Insulinemic biomarker concentrations(Baseline and week 6)
- Blood pressure(Baseline, week 3, week 6)
- Dietary intake(Baseline, week 1, week 2, week 3, week 4, week 5, week 6)
- Physical activity(Baseline, week 6)
- Body composition(Baseline, week 3, and week 6)
- Sleep(Baseline, week 6)
- Palatability rating of foods(Baseline, week 3, week 6)
- Body mass(Baseline, week 3, and week 6)
- Lipid profile(Baseline and week 6)
研究者
Jaapna Dhillon
Assistant Professor
University of Missouri-Columbia