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临床试验/NCT06221696
NCT06221696已完成不适用

Preventing Weight Regain Post-Semaglutide Treatment With Active Fiber Supplement (Soloways): A Randomized, Placebo-Controlled, Double-Blind Clinical Trial

S.LAB (SOLOWAYS)2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年6月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
160
试验地点
2
主要终点
Percentage of weight regain from baseline

研究概览

简要总结

This randomized, double-blind, placebo-controlled trial titled "Preventing Weight Regain Post-Semaglutide Treatment with Active Fiber Supplement (Soloways)" evaluated the efficacy of an active fiber supplement in preventing weight regain post-Semaglutide treatment. Participants were adults aged 18-65, with a history of obesity or overweight, and had completed a Semaglutide course. The study involved 160 participants, equally divided into two groups: one receiving the active fiber supplement (glucomannan, inulin, and psyllium) and the other a placebo, both taken 30 minutes before each main meal for 180 days. Co-primary endpoints were the percentage of weight regain from baseline to day 180 and metabolic health markers (blood glucose levels, HbA1c, lipid profile, blood pressure). Secondary endpoints included changes in BMI, body composition, and appetite assessment using VAS ratings and the Control of Eating Questionnaire (CoEQ). Participants also adhered to a reduced-calorie diet and increased physical activity, with all standard assays performed in a central laboratory. The study's objective was to determine the supplement's effectiveness in enhancing satiety, improving digestive health, and thus better managing weight compared to a placebo

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

入选标准

  • Adults with a history of obesity or overweight and completed Semaglutide course.
  • Age 18-65 years.-

排除标准

  • Serious chronic illnesses.
  • History of bulimia or anorexia.
  • Pregnancy or lactation.

结局指标

主要结局

Percentage of weight regain from baseline

时间窗: 180 days

次要结局

  • Visceral fat rating change from baseline(180 days)
  • blood LDL change(180 days)
  • visceral fat changes(180 days)
  • blood triglycerides change(180 days)
  • BMI changes(180 days)
  • blood glucose levels change(180 days)
  • blood total cholesterol change(180 days)
  • total body water changes(180 days)
  • Effect of glucomannan, inulin, and psyllium on appetite assessed using mean postprandial participant-reported visual analog score (VAS) ratings from 0 to 10 points, where 0 is appetite absence and 10 good appetite, following a standardized breakfast(180 days)
  • blood HbA1c change(180 days)
  • Systolic and diastolic blood pressure change(180 days)
  • fat-free mass changes(180 days)

研究者

发起方
S.LAB (SOLOWAYS)
申办方类型
Other
责任方
Sponsor

研究点 (2)

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