A Randomized, Double-blind, Double-arm Study Conducted Directly With Consumers Via an App "Baritastic App", Evaluating the Efficacy of a Supplement Containing Bifidobacterium Lactis B420 and Pasteurized Akkermansia Muciniphila (UltraFlora® Triplebiotic) for 3 Months in Adults After Discontinuation of GLP-1 Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 128
- 主要终点
- weight measurement
研究概览
简要总结
This is a randomized, double-blind, double arm study involving 128 participants who will undergo a total participation period of 12 weeks.
详细描述
The trial begins with a screening to assess eligibility, followed by a 12-week treatment phase during which participants will receive a fixed-dose oral supplementation regimen. During this treatment period, participants will take UltraFlora® Triplebiotic at a fixed dose of 2 capsule per day, administered orally once daily with food. During the 12-week treatment period, participants will be asked to complete questions and track their weight changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Providing written informed consent
- •Males and females of at least 18 years old
- •Body mass index (BMI) between 25 and 30 (including 25 and 30) (Weight: 25 < BMI < 30)
- •Having undergone treatment with GLP-1 for more than 3 months but for less than 1 year.
- •Having stopped GLP-1 treatment for a maximum of 4 weeks
- •Being willing to maintain stable dietary habits and physical activity levels throughout the trial period
- •Being willing not to introduce any other food supplements during the trial period (supplements used in the two weeks prior to enrolling in the trial and used consistently throughout are acceptable, except for probiotics).
排除标准
- •Being on GLP-1 treatment
- •Having had any type of bariatric surgery, or planned bariatric surgery during the period of trial participation.
- •Suffering from a severe chronic disease (e.g., cancer, HIV, hepatic or renal impairment, diabetes type I), inflammatory bowel disease (IBD), Coeliac Disease, and/or being immunocompromised.
- •Suffering from any uncontrolled endocrine disorder.
- •Having consumed any probiotic supplements in the 3 months prior to enrollment.
- •Having used any antibiotic treatment in the 3 months prior to enrollment.
- •Having a known allergy to the ingredients in the study product.
- •Being pregnant or lactating (breastfeeding) or trying to become pregnant.
- •Participating in an other clinical trial.
- •Suffering from dementia or inability to take the trial treatment in an appropriate way.
- •Taking UltraFlora® Triplebiotic or any similar product from competitors prior to trial participation
结局指标
主要结局
weight measurement
时间窗: From enrollment to the end of treatment at 12 weeks (90 days)
Evaluate the impact of UltraFlora Triplebiotic (containing Bifidobacterium Lactis B420 and pasteurized Akkermansia Muciniphila) on weight regain over 3 months after discontinuation of GLP-1.
次要结局
- IBS-SSS (Irritable Bowel Syndrome - Severity Scoring System) questionnaire(From enrollment to the end of treatment at 12 weeks (90 days))
- SVS (Subjective Vitality Scale) questionnaire(From enrollment to the end of treatment at 12 weeks (90 days))
- TFEQ-R18 (Three-Factor Eating Questionnaire - Revised 18 items) Questionnaire(From enrollment to the end of treatment at 12 weeks (90 days))