A randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy and safety of Flavinergy on metabolic health of overweight adults.
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- 1. Change in Visceral fat area.
研究概览
简要总结
The study involves 80 subjects randomized in two arms and will receive 90 days of treatment and telephonic follow-up after 7 days following the last visit. Participant will be randomized to receive either test product (Flavinergy- extract of Black- Thai Ginger)- 150mg or placebo (Microcrystalline cellulose) twice a day. Specific biomarkers like lipid profile, fasting blood sugar will be measure along with CT scan to measure the Sub-cutaneous Fat Area, Visceral Fat Area and Total Fat Area during the study period. The final statistical analysis and study report will be complied at the end of the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants should be willing to give signed written informed consent.
- •Participants should be willing to comply with the requirements of the trial/study.
- •Male and Female participants aged between 25-55 years.
- •Subjects whose BMI lie between 25 to 29.99 kg/m
- •Subjects who meet any of the two criteria to be included in the study: a) Triglyceride more than 160mg/dl b) HDL Cholesterol less than 50 mg/dl in women and less than 40 mg/dl in men c) LDL Cholesterol more than 120 mg/dl d) Serum Total Cholesterol more than 200 mg/dl 6) Blood Pressure more than 130/90 mmHg without medication.
- •Fasting Blood Glucose more than 120 mg/dl without medication.
- •Ability to swallow and retain oral medications as per the protocol.
排除标准
- •Subjects who are taking any anti-obesity medication or weight reduction treatments including the herbal preparations.
- •Subjects with abnormal thyroid profile.
- •History of surgical procedures for weight loss.
- •Use of supplements, special diet or functional foods affecting carbohydrate and lipid metabolism during the study period.
- •History of chronic smoking and alcoholism.
- •Pregnant, lactating women and those not willing to follow a reliable and effective contraceptive measure during the study period.
结局指标
主要结局
1. Change in Visceral fat area.
时间窗: 1. Change in Visceral fat area from day-1 to day-90. | 2. Change in lipid profile from screening to day-90.
2. Change in lipid profile
时间窗: 1. Change in Visceral fat area from day-1 to day-90. | 2. Change in lipid profile from screening to day-90.
次要结局
- 1. Change in Body weight & BMI.(2. Mean change in Anthropometric measurement)