A randomized, double-blind, placebo-controlled study of oral supplementation of low molecular weight galactomannan based standardized fenugreek seed extract (INDUS810) on fat mass in overweight females.
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- To evaluate the efficacy of INDUS810 oral supplementation (Capsules) on percent fat mass as measured by DEXA
研究概览
简要总结
One hundred and forty subjects of age 18- 60 will be assigned in 1:1 ratio to treatment with the test product, INDUS810 capsules or Placebo in this double- blind, randomized, placebo- controlled study. All 140 enrolled subjects will be instructed to take two capsules of INDUS810 capsules and Placebo, once daily in the morning, before meal (empty stomach) for 12 weeks. Subjects will be required to use diaries to document the date, time and dosage of study treatments including any missed doses and the occurrence of any adverse events. The efficacy of investigational product will be assessed primarily with DEXA Scan. Primary objective is to evaluate the efficacy of INDUS810 oral supplementation (Capsules) on percent (%) fat mass. High-fat mass (HFM) prevention is a critical factor in controlling related non-communicable diseases such as insulin resistance, metabolic syndrome, hyperinsulinemia, type 2 diabetes,hyperlipidemia, hypertension, and coronary artery disease. Low-molecular-weight galactomannan based standardized fenugreek seed extract (INDUS810) oral supplementation has shown efficacy against high fight mass and related health problems in previous preclinical and clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
- •Women with age between 18 to 60 years
- •Healthy females with body mass index (BMI) of 25 to 30 kg per m2
- •Willing to continue with their existing diet, exercise, and lifestyle habits throughout the study, without any change.
- •Agree to avoid consuming any supplements meant for weight or fat loss during the study period.
排除标准
- •Participants meeting any of the following criteria will be excluded from the study:
- •Allergy or sensitivity to any ingredient of investigational product
- •Participation in any clinical study within 30 days before randomization.
- •Use of natural health products or dietary supplements within 7 days before randomization and during the study.
- •Pregnant or planning to be pregnant and lactating.
- •Any kind of substance abuse, (alcohol, tobacco, or any other substance).
- •Participant taking cholesterol lowering medications, for eg.
- •Statins like atorvastatin, Fibrates like fenofibrate
- •Participant with a history of hyper or hypo thyroidism and currently taking hyper or hypo thyroid medicines.
- •Uncontrolled metabolic diseases or chronic diseases at the discretion of the investigator
- •Current diagnosis of immune-compromised conditions like HIV or AIDS, cancer
- •History of blood or bleeding disorders; blood donation in the previous 2 months.
- •Any other condition that in the qualified investigator’s opinion may have adversely affected the participant’s ability to complete the study or its measures or which may have posed a significant risk to the participant.
结局指标
主要结局
To evaluate the efficacy of INDUS810 oral supplementation (Capsules) on percent fat mass as measured by DEXA
时间窗: Baseline, Week 6, Week 12
次要结局
- A: Efficacy 1. Total body mass composition:Absolute fat mass,Lean mass,BMC,Fat-free mass,Body weight,Total tissue mass 2. Visceral adipose tissue Segmental body composition through tissue percent fat, region percent fat, tissue mass,fat mass,lean mass,BMC,total mass in Arms, Legs, Trunk, Android, Gynoid,Android to Gynoid ratio,Total,Fat mass ratio 4. Total BMD 5. Resting Metabolic Rate 6. Relative skeletal muscle mass index 7. Anthropometric measures:Waist circumference,Hip circumference,Waist-hip ratio,Abdominal girth 8. BMI 9. Fatty Liver Index 10. NAFLD liver fat score & fat percent 11. Dose and frequency of ongoing medication taken for fat mass related co-morbidities. 12. LFT 13. Lipid & carbohydrate metabolism parameters 14. Phenotypic Age 15. Physical activity: 6-MWT, 30-sec chair stand test 16. Quality of life:SF-36 B. Safety: 1. Clinical examination 2. Vital signs 3. hematology,KFT,urine analysis 4.Adverse events(Baseline, Week 6, Week 12)
研究者
Dr Subhal Dixit
Sanjeevan Hospital