Benefits of Almond Consumption in Modulation of Intestinal Microbiome and Novel Disease Risk Biomarkers: A Randomized Controlled Dietary Intervention Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Gastrointestinal microbiome
研究概览
简要总结
The overall goal is to assess the health benefits of almond consumption on gut microbiome patterns and their association with circulating disease risk biomarkers, as well as the processes that control those pathways. Health benefits will be assessed relative to a omelette control.
详细描述
Men and women with elevated waist circumference aged between 18-75 yrs will be recruited from the Winnipeg (Manitoba, Canada) area to participate in a two arm crossover, randomized study; each treatment period will be 4 weeks in length, with a 4 week washout period separating each treatment. Participants will be randomized to consume either i) almonds, or ii) omelettes at 15% of energy. Each of the treatment products will contain equal levels of calories.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to give written informed consent
- •Men and women 18-75 yr
- •Elevated waist circumferences (women greater than or equal to 80 cm, men greater than or equal to 94 cm)
- •LDL-C greater than or equal to 2.8 mmol/L, or less than or equal to 4.9 mmol/L
- •Non-smokers
- •Possess a telephone or email address to enable regular contact
- •Able to read, write and speak English
排除标准
- •Pregnant female, or planning to become pregnant during the study period
- •Weight gain or loss of at least 10lbs in previous three months
- •Allergic to almonds, eggs, milk
- •Exercising > 15 miles/wk or 4,000 kcal/wk
- •Those currently taking (or have taken within the past 3 months) lipid-lowering medications (i.e., statins)
- •Those currently taking (or have taken within the last 3 months) lipid-lowering supplements (i.e., omega-3 supplements, plant sterols/stanol foods and/or supplements, fibre, etc.)
- •Those currently taking (or have taken within the last 3 months) probiotic supplements and foods containing added probiotics (i.e., kefir, Activia, Kashi: Vive Probiotic Digestive Wellness Cereal)
- •Previous history of diabetes, hypertension, gastrointestinal disease, liver or lung disease or cancer, hyperthyroidism or hypothyroidism, or lung disease.
- •Alcohol use of >2 drinks/day
结局指标
主要结局
Gastrointestinal microbiome
时间窗: 4 weeks
Bacterial community alpha-diversity measured using richness and diversity indices including Chao1, Shannon, Inverse Simpson. Bacterial community beta-diversity measured using weighted and unweighted UniFrac distances. The most abundant Operational Taxonomic Units (OTUs) within the bacterial community identified based on the relative abundances of the OTUs within the community. Bacterial community composition at the phylum and genus levels described based on the relative abundances of each taxa within the community. Bacterial community functional capacity measured based on the relative abundances of collected predicted functions of the community members. Ecological relationships between members of bacterial community assessed using correlation network modelling to identify keystone and foundation members of the bacterial community that have the highest number of positive (supportive) or negative (suppressive) connections (\>15) with other members of community.
次要结局
- Blood high-density lipoprotein cholesterol(4 weeks)
- Tumor necrosis factor alpha(4 weeks)
- C-reactive protein(4 weeks)
- Vascular cell adhesion molecule 1(4 weeks)
- 7α-hydroxy-4-cholesten-3-one(4 weeks)
- Interferon gamma(4 weeks)
- Blood low-density lipoprotein cholesterol(4 weeks)
- Interleukin 1 beta(4 weeks)
- Serum amyloid A(4 weeks)
- Intercellular adhesion molecule 1(4 weeks)
- Cholesterol synthesis rate(4 weeks)
- Cholesterol absorption rate(4 weeks)
- Blood pressure(4 weeks)
- Interleukin 6(4 weeks)
- Fecal short chain fatty acids(4 weeks)
- Waist circumference(4 weeks)
- Body mass index(4 weeks)
- Hip circumference(4 weeks)
- Blood total cholesterol(4 weeks)
- Fatty acid synthesis rate(4 weeks)
- Blood triglycerides(4 weeks)