Spices for Cultivating a Healthy Gut Microbiome and Cardiometabolic Profile: the SPICE Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Concentration of fecal short chain fatty acids including acetate, proprionate, and butyrate
研究概览
简要总结
Among food products receiving attention for prebiotic functionality, spices represent a flavorful vehicle for cultivating a healthy gut microbiota. As the required doses of spice-derived polyphenols to elicit prebiotic and systemic metabolic effects are not well-characterized, additional research is warranted. Thus, the investigators propose to use a food-first synbiotic (prebiotic + probiotic) approach to examine alterations in the gut microbiota pre- and post-intervention/placebo and their relationship with systemic cardiometabolic effects mediated by short chain fatty acids (SCFA) and gut-derived metabolites.
详细描述
Study will be conducted as a single blind, randomized crossover design with a 4-week arm (placebo or control) followed by a 2-week washout period and another 4-week arm (placebo or control).
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
- Single (Investigator)
盲法说明
The study coordinator and participants are unblinded due to the nature of the study design and intervention; however, the PI will remain blinded.
入排标准
- 年龄范围
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •post-menopausal women ages 50-69y with a BMI of 18.5 - 34.9 kg/m2
排除标准
- •Dx - Diagnosis of cardiovascular disease, type 1 or 2 diabetes, liver disease, cancer, endocrine disorders, or inflammatory condition such as rheumatoid arthritis.
- •GI - History of gastrointestinal surgery, irritable bowel syndrome, intestinal bowel disease, or other gastrointestinal distress such as chronic diarrhea, bulimia, anorexia, or frequent laxative use
- •Rx or Supplements - Actively taking steroids or antibiotics in the previous two to three months, or currently using tobacco products, > 10% weight loss or gain in the last 6 months, unwilling to stop taking prebiotic/probiotic or fiber supplements
- •Dietary - Adherence to a high fiber/polyphenol rich diet, have an allergy, aversion, or intolerance to food and spices provided in this study
研究组 & 干预措施
Intervention Arm - Yogurt with added Spices
Consumption of twice daily yogurt with added spices for four weeks.
干预措施: Yogurt with added Spices (Other)
Sham Arm - Yogurt without added Spices
Consumption of twice daily yogurt without added spices for four weeks.
干预措施: Yogurt without added Spices (Other)
结局指标
主要结局
Concentration of fecal short chain fatty acids including acetate, proprionate, and butyrate
时间窗: pre/post each four-week study arm
Units - uM
Concentration of serum leptin
时间窗: pre/post each four-week study arm
Units - ng/mL
Concentration of serum ghrelin (pg/mL)
时间窗: pre/post each four-week study arm
Units - pg/mL
Concentration of serum peptide tyrosine tyrosine (PYY)
时间窗: pre/post each four-week study arm
Units - pg/mL
次要结局
未报告次要终点