Effectiveness and Safety of Semaglutide Combined With Dietary Fiber (Soloways) in Adults With Overweight or Obesity: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Achievement of a reduction in body weight of 5% or more from baseline.
研究概览
简要总结
This clinical trial investigated the combined effects of Semaglutide and a fiber supplement (glucomannan, inulin, psyllium) on weight loss in adults with overweight or obesity. Participants, aged 18-65 with a BMI ≥30 or ≥27 with comorbidities, were randomized into two groups: one receiving Semaglutide with active fiber supplements and the other with Semaglutide and placebo, over a 180-day period. Key endpoints included percentage change in body weight, BMI, body composition, safety, and appetite control, with a focus on evaluating the additive effects of dietary fibers in enhancing Semaglutide's efficacy.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •BMI ≥30, or ≥27 with comorbidities.
排除标准
- •Serious chronic illnesses.
- •History of bulimia or anorexia.
- •Pregnancy or lactation.
研究组 & 干预措施
Placebo group
干预措施: placebo (Other)
Semaglutide with Active Fiber Supplement Group
干预措施: Fiber Supplement Group (Dietary Supplement)
结局指标
主要结局
Achievement of a reduction in body weight of 5% or more from baseline.
时间窗: 180 days
Percentage change in body weight from baseline
时间窗: 180 days
次要结局
- BMI change(180 days)
- fat mass change(180 day)
- fat-free mass change(180 days)
- total body water change(180 days)
- visceral fat rating change(180 days)
- Safety evaluated by recording any adverse events.(180 days)