FaibaLite - Reduce Weight, One Bite at a Time
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Composite primary endpoint: Feasibility of conducting the study based on participant adherence rate, user acceptance score, and dropout rate
研究概览
简要总结
This study aims to evaluate the suitability of a fiber-enriched chewing gum as a practical and accessible approach to support healthy body weight management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written Informed Consent
- •Healthy adults aged 18 to 65 years (inclusive), as determined by the investigator
- •BMI of 23 to 40 kg/m2 (inclusive)
- •Living in Switzerland
- •Ability and willingness to follow the study protocol (e.g., cognitive capacity for compliance, gum chewing)
- •Access and willingness to use an electronic device (e.g., mobile phone, computer or tablet)
- •Access to a scale to self-report weight
排除标准
- •Current weight loss therapy with Glucagon-like Peptide 1 (GLP-1) agonists or other non-prescription products (at investigator's discretion)
- •Treatment with a GLP-1 agonist within the past 2 months
- •Initiation/Discontinuation of nicotine product use (>1 nicotine product per day, e.g., (e-)cigarette, gum) within the last 2 months (at investigator's discretion)
- •Significant change in medication within the last 2 months (at investigator's discretion)
- •Unable to chew gum 3 times daily (e.g. due to dental issues, at investigator's discretion)
研究组 & 干预措施
FibreGum Intervention Group
Participants chew one fiber-containing gum (FibreGum) three times daily (morning, noon, and evening) for at least 20 minutes each, over two months, with the option to extend the intervention to three months.
干预措施: FibreGum chewing gum (Dietary Supplement)
结局指标
主要结局
Composite primary endpoint: Feasibility of conducting the study based on participant adherence rate, user acceptance score, and dropout rate
时间窗: Up to 3 months (end of chewing phase)
Feasibility will be assessed as a composite endpoint including the following parameters among healthy adults: * Participant adherence rate (percentage of recommended chewing performed) * User acceptance score (based on questionnaire) * Dropout rate (percentage of participants who discontinue the study prematurely)
次要结局
- Reduction in body weight (%)(2 or 3 months)
- Change in body composition (body fat)(2 or 3 months)
- Change in body composition (lean mass)(2 or 3 months)
- Change in body composition (muscle mass)(2 or 3 months)
- Change in gut microbiota alpha-diversity(2 months)
- Change in gut microbiota beta-diversity(2 months)
- Change in differential abundance of gut microbiota(2 months)
- Changes in body weight during follow-up(1 or 2 months)
- Reduction in body weight (%)(2 or 3 months)
- Change in body composition (muscle mass)(2 or 3 months)
- Change in differential abundance of gut microbiota(2 months)
- Change in gut microbiota beta-diversity(2 months)
- Changes in body weight during follow-up(1 or 2 months)
- Change in body composition (body fat)(2 or 3 months)
- Change in body composition (lean mass)(2 or 3 months)
- Change in gut microbiota alpha-diversity(2 months)
- Duration of intervention(Up to 3 months after study start)