A Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy of CitruSlim® on Body Composition as Well as Metabolic and Hormonal Factors in Overweight and Obese Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Change in body fat percent Body Mass Index (kg/m2)
研究概览
简要总结
CitruSlim® can promote healthy weight loss by promoting anabolic state during weight loss programs, prevent the body from storing fat, reduce appetites and maintain healthy cholesterol and blood glucose level during weight loss program.
This study focuses to prove the efficacy and safety of the product in a population of overweight and obese individual.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants with the age of ≥18 and ≤ 60 years of age.
- •BMI of ≥25 - ≤ 35 kg/m2
- •Waist circumference:India: Men: > 94 cm (37 inches), Women: >80 cm (31.5 inches) USA: Men: > 102 cm (40 inches), Women: >89 cm (35 inches)
- •Triglycerides >150 mg/dL
- •Blood pressure: Systolic: ≥130 mm Hg and/or Diastolic: ≥85 mm Hg
- •Fasting blood glucose ≥ 100 mg/ dl
- •Low HDL level: Men: < 40 mg/dL, Women: < 50 mg/dL
- •Ready to give voluntary, written, informed consent to participate in the study.
排除标准
- •Participants meeting any of the following criteria will be excluded from the trial:
- •Current smoker.
- •Inability to walk independently.
- •Presence of unstable, acutely symptomatic, or life-limiting illness.
- •Neurological conditions causing functional or cognitive impairments
- •Unwillingness or inability to be randomized to one of three intervention groups.
- •Bilateral hip replacements.
- •Exposure to any non-registered drug product within 3 months prior to the screening visit.
- •Unable/unwillingness to complete study specific diaries (digital/paper-based).
研究组 & 干预措施
Citrus flavonone-O-glycosides (High dose)
干预措施: Citrus flavonone-O-glycosides- HD (Dietary Supplement)
Citrus flavonone-O-glycosides (Low dose)
干预措施: Citrus flavonone-O-glycosides- LD (Dietary Supplement)
Microcrystaline Cellulose- 400mg
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in body fat percent Body Mass Index (kg/m2)
时间窗: 16 weeks.
Assessed using DEXA
Change in Lean Body Mass (g)
时间窗: 16 weeks
Assessed using DEXA
Change in Body Fat (%)
时间窗: 16 weeks
Assessed using DEXA
Change in Fat Free Mass (g)
时间窗: 16 weeks
Assessed using DEXA
次要结局
未报告次要终点