NCT06188832已完成不适用
Efficacy of Dietary Fiber Supplementation (Soloways) in Patients With Specific Genetic Polymorphisms
S.LAB (SOLOWAYS)2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2022年3月2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
- 108
- 试验地点
- 2
- 主要终点
- Body-weight change in %
研究概览
简要总结
This randomized, double-blind, placebo-controlled trial assessed the impact of a dietary fiber supplement (glucomannan, inulin, and psyllium) on weight and metabolic parameters in individuals with obesity-related genetic polymorphisms (FTO, MC4R, LEP, LEPR). Participants were adults aged 18-65 with a BMI ≥ 25 and confirmed genetic predispositions. The study, involving 216 participants (108 per group), ran over 12 weeks with assessments at 0, 4, 8, and 12 weeks. Primary outcome was Body-weight change in %. The study aimed to clarify the role of fiber supplements in genetically predisposed obese individuals.
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
- Double (Participant, Care Provider)
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
- •Confirmed presence of one or more specified gene polymorphisms (FTO, MC4R, LEP, LEPR).
- •Overweight or obese status (BMI ≥ 25).
排除标准
- •BMI < 25
结局指标
主要结局
Body-weight change in %
时间窗: 180 days
次要结局
- LDL-C ratio(180 days)
- Triglycerides ratio(180 days)
- Body weight in kg(180 days)
- Fat-free mass change in kg(180 days)
- Visceral fat rating change from baseline(180 days)
- Total cholesterol ratio(180 days)
- hsCRP ratio(180 days)
- Fasting plasma glucose mmol/l(180 days)
- Side effects %(180 days)
- body-weight reduction ≥5%(180 days)
- body-weight reduc-tion ≥10%(180 days)
- Fat mass change in %(180 days)
- Systolic blood pressure in mmHg(180 days)
- HDL-C ratio(180 days)
- Body mass index change in %(180 days)
- Diastolic blood pressure in mmHg(180 days)
研究者
研究点 (2)
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