A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of SlimBiotics Probiotic Formula on Weight Management and Metabolic Health Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in Visceral Fat Mass (VFM) [Time Frame: Baseline to Week 12]
研究概览
简要总结
This study is to evaluate the efficacy of a probiotic supplement on weight management and metabolic health. This study will be conducted as a hybrid trial consisting of both in-person visits and virtual assessments. Two groups will be included: the intervention (SlimBiotics Probiotic) and placebo.
The SlimBiotics probiotic formula is the first plant-based probiotic targeting weight management and metabolic health. Other competing probiotics are isolated from humans (feces) but the strains in SlimBiotics were isolated from a fermented plant (millet porridge cereal).
This product contains 3 probiotic strains:
Limosilactobacillus fermentum K7-Lb1 Limosilactobacillus fermentum K8-Lb1 Limosilactobacillus fermentum K11-Lb3
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Both participant groups and the study coordinators will be blinded to the allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women & Men
- •BMI between 25-32
- •Generally healthy - don't live with any uncontrolled chronic disease
- •Own a sleep-tracking device (smart watch etc.)
排除标准
- •Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- •Anyone with known severe allergic reactions.
- •Women who are pregnant, breastfeeding or attempting to become pregnant
- •Unwilling to follow the study protocol.
- •Subjects currently enrolled in another clinical study
- •Subjects having finished another clinical study within the last 4 weeks before inclusion
- •Hypersensitivity, allergy or intolerance against any compound of the test products (e. g. acacia gum)
- •Condition after implantation of a cardiac pacemaker or other active implants
- •Sulfonylurea treatment
- •Any disease or condition which might compromise significantly the hepatic (ascites), hematopoietic, renal, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system with the exception of the conditions defined by the inclusion criteria
- •History of or present liver deficiency as defined by Quick < 70%
- •Regular medical treatment including over-the-counter, which may have an impact on the study aims (e.g. probiotics containing supplements, laxatives, steroids etc.)
- •History of hepatitis B, C, HIV
- •Subjects who are scheduled to undergo any diagnostic intervention or hospitalization which may cause protocol deviations
- •Simultaneous study participation by members of the same household
- •Pregnancy and lactation
- •Ascites as assessed by sonography
- •Any diet to lose body weight
- •Eating disorders or vegan diet
- •Anorexia drugs
- •Present drug abuse or alcoholism
结局指标
主要结局
Change in Visceral Fat Mass (VFM) [Time Frame: Baseline to Week 12]
时间窗: 12 weeks
VFM will be measured as an assessment of weight management.
Changes in total cholesterol [Time Frame: Baseline to Week 12]
时间窗: 12 weeks
Total cholesterol will be assessed as part of a lipid panel blood test.
Changes in blood levels of low-density lipoprotein. [Time Frame: Baseline to Week 12]
时间窗: 12 weeks
Blood levels of low-density lipoprotein will be assessed as part of a lipid panel blood test.
Change in Body Weight [Time Frame: Baseline to Week 12]
时间窗: 12 weeks
Body weight will be measured as an assessment of weight management.
Change in Waist Circumference. [Time Frame: Baseline to Week 12]
时间窗: 12 weeks
Waist circumference will be measured as an assessment of weight management.
Change in blood pressure. [Time Frame: Baseline to Week 12]
时间窗: 12 weeks
Blood pressure will be measured as a marker of metabolic health. Both both systolic and diastolic blood pressure will be measured.
Change in resting heart rate. [Time Frame: Baseline to Week 12]
时间窗: 12 weeks
Resting heart rate will be measured as a marker of metabolic health.
Changes in metabolic health symptoms. [Time Frame: Baseline to Week 12]
时间窗: 12 weeks
Survey based assessment (0-5 scale) of changes in metabolic health symptoms.
Changes in blood levels of triglycerides. [Time Frame: Baseline to Week 12]
时间窗: 12 weeks
Triglycerides will be assessed as part of a lipid panel blood test.
Changes in blood levels of high-density lipoprotein. [Time Frame: Baseline to Week 12]
时间窗: 12 weeks
Blood levels of high-density lipoprotein will be assessed as part of a lipid panel blood test.
Changes in blood glucose. [Time Frame: Baseline to Week 12]
时间窗: 12 weeks
Blood glucose levels will be assessed via blood test.
Changes in blood insulin levels. [Time Frame: Baseline to Week 12]
时间窗: 12 weeks
Blood insulin levels will be assessed via blood test.
Changes in hbA1c. [Time Frame: Baseline to Week 12]
时间窗: 12 weeks
hbA1c will be assessed via blood test.
Changes in gamma-glutamyl transferase (GGT). [Time Frame: Baseline to Week 12]
时间窗: 12 weeks
GGT will be assessed via blood test.
Changes in hs-high-sensitivity C-reactive protein (hsCRP). [Time Frame: Baseline to Week 12]
时间窗: 12 weeks
hsCRP will be assessed via blood test.
Changes in alanine transaminase. [Time Frame: Baseline to Week 12]
时间窗: 12 weeks
Alanine transaminase will be assessed via blood test.
Changes in aspartate aminotransferase. [Time Frame: Baseline to Week 12]
时间窗: 12 weeks
Aspartate aminotransferase will be assessed via blood test.
次要结局
- Changes in participants-perceived sleep quality. [Time Frame: Baseline to Week 12](12 weeks)
- Changes in sleep duration. [Time Frame: Baseline to Week 12](12 weeks)
- Changes in participant-reported mental wellbeing. [Time Frame: Baseline to Week 12](12 weeks)
- Changes in scores on the Anxiety GAD7 Questionnaire [Time Frame: Baseline to Week 12](12 weeks)
- Changes in health eating habits. [Time Frame: Baseline to Week 12](12 weeks)