The Effects of a Commercially Available Synbiotic on the Gut Microbiome and Cardiometabolic Health: A Randomized Double-Blind Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Gut microbiome diversity and total bacteria
研究概览
简要总结
The purpose of this study is to see the effect of 30 days of synbiotic vs. probiotic supplementation (usingJuice+ nutrition products) on body weight, metabolism, cardiovascular health, and gut health. This study will provide information for future studies and how such supplementation might influence health long term. You are being asked to participate because you are 18-60 years old, relatively healthy 1 or fewer risk factors for cardiovascular disease), and have been weight stable (weight within ±4.4 lbs) for at least 6 months.People who present with 2 or more cardiovascular disease risk factors (we will ask you this information) or have uncontrolled/overt cardiovascular, pulmonary, or metabolic disease (Diabetes Mellitus), or recent blood donation (<8 weeks) will not be able to participate. Those who have been diagnosed and/or are being treated for cancer will not be able to participate. Anyone recently (<1yr) diagnosed with an eating disorder is also not eligible to participate. Women who are currently pregnant, breastfeeding, attempting to conceive, or without a period will not be allowed to participate. Anyone who is being treated for hypothyroid with levothyroxine will be excluded as one of the supplement ingredients, chromium polynicotinate, may interfere with this medication. Given the focus of the study, those who are currently, or have recently used (<3 months), oral antibiotics or have diagnosed irritable bowel syndrome or gut/bowel maladies (short bowel syndrome, etc.) will be excluded Anyone with severe illness or compromised or suppressed immune system (e.g. taking immune suppressants, chronic viral infection or treatment) will be excluded. Please discuss any other potential food allergies with the research team, as food allergies will disqualify you from participating. About 48 people will take part in this research.
详细描述
Accordingly, the purpose of this study is to evaluate the efficacy of 1) supplementation with a novel Synbiotic (JuicePlus), or 2) placebo control over 30 days on the gut microbiome, cardiometabolic health, body weight, and body composition in healthy individuals.
Specific Aim 1. Explore the changes in the gut microbiome using 16s rRNA sequencing to determine total bacterial counts, microbial diversity (alpha- and beta-diversity), short chain fatty acid (SCFA) concentration, circulating inflammatory biomarkers and mucosal immunity as a result of a novel synbiotic vs. placebo control.
Specific Aim 2. Document the functional changes in cardiometabolic health-related parameters; specifically, heart rate, heart rate variability (HRV), blood pressure (central and peripheral), vascular stiffness (augmentation index, AIx, and pulse wave velocity, PWV), body weight and composition, blood glucose and lipids as a result of a novel synbiotic vs. placebo control.
Specific Aim 3. Characterize the impact of synbiotic vs. placebo control on perceptions of gut health (questionnaire), and mood states, given the gut-brain axis.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be included participants must be healthy, weight stable (± 4.4 lb for > 6 months prior), and 18 to 60 years of age.
- •Participants will be expected to be relatively healthy without uncontrolled chronic disease (e.g. cardiovascular, metabolic, or pulmonary) and 2 or fewer positive risk factors for cardiovascular disease (e.g. high blood pressure, high cholesterol, etc.) as described by the American College of Sports Medicine/American Heart Association Criteria [18] and presented in the table 1 below.
- •Participants will be screened for eligibility by a health history form (Appendix A) in person before baseline measurements are made (Figure 1).
- •To ensure greater inclusion, ecological validity, and representation, women will be included in this study; however, we will not control for the menstrual cycle phase, but will document for possible statistical consideration.
排除标准
- •Given the focus of the study, those who are currently, or have recently used (<3 months), oral antibiotics or have diagnosed irritable bowel syndrome or gut/bowel maladies (short bowel syndrome, etc.) will be excluded [19].
- •Subjects who present with more than 2 CVD risk factors (table above) or have uncontrolled/overt cardiovascular, pulmonary, or metabolic disease (Diabetes Mellitus), or recent blood donation (<8 weeks) will be excluded.
- •Those who have cancer or are being treated for cancer will also be excluded. Women who are currently pregnant, breastfeeding, attempting to conceive, or amenorrheic (not associated with menopause or use of contraceptive medications) will also be excluded from the study.
- •Anyone with severe illness or compromised or suppressed immune system (e.g. taking immunosuppressants, chronic viral infection or treatment) will be excluded [20]. Anyone recently diagnosed (<1yr) with an eating disorder will also be excluded.
- •Finally, anyone with food allergies should be cautioned but those with known sensitivity to wheat, acacia gum, stevia, maltodextrin, or rice flour should not participate and will be excluded.
研究组 & 干预措施
Treatment group
30 day supplementation of synbiotic
干预措施: Synbiotic (Dietary Supplement)
结局指标
主要结局
Gut microbiome diversity and total bacteria
时间窗: 30 days
Explore the changes in the gut microbiome using 16s rRNA sequencing to determine total bacterial counts, microbial diversity (alpha- and beta-diversity).
Blood biomarkers
时间窗: 30 days
Blood markers of short chain fatty acid (SCFA) concentration, circulating inflammatory biomarkers and mucosal immunity
次要结局
- Hypertension(30 days)