A Prospective, Open Label, Randomized, Crossover, Controlled Study to Evaluate the Benefits of Saffola Oats with Diet & Exercise in Improving Cardiovascular Health on Normolipidemic Individuals - Nil

Spectrum Clinical Research Pvt Ltd0 个研究点目标入组 60 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1 Male & female, Age 25 to 50 yrs (inclusive)
•2 LDL Cholesterol in between 110 - 130 mg %
•3 BMI 23 30 kg/m2
•4 Weight : At least 10 kgs overweight than the desired Body weight and at least one of the following conditions:
•i) Controlled Hypertension (BP 140/90mm Hg)
•ii) Pre Diabetes (Fasting 100- 126 mg/dL & 2hours post load (OGTT) 140- 199 mg/dL
•5 Subject is clinically stable and all laboratory investigations are clinically acceptable as per P.I Discretion

•1. BMI > 30 kg/m2
•Subjects suffering from any 1 of the following diseases that can be considered as a risk factor‐ Diabetes, CAD, CVD, Coronary Artherosclerosis and uncontrolled hypertension according to the Principal investigator.
•2. Subject undergone coronary artery bypass graft (CABG) or any other major cardiac surgery.
•3. Subjects taking lipid lowering drugs including Simvastatin, Pravastatin, Fluvastatin, Atorvastatin, Cerivastatin, Rosuvastatin etc.
•4. Subjects with clinical signs and symptoms of liver, kidney or thyroid disorders.
•5. Subjects having TB
•6. Pregnant and lactating women
•7. Oat users
•8. Subjects having known hypersensitivity to Oats or Oats products.
•9. Subjects who has a fiber intake > 25 g/day
•10. Subjects who are on caloric reduction diet/ change dietary constituents frequently
•11. Athletes or Subjects who do any form of exercise everyday (jogging, brisk walking, swimming, weight lifting etc.)
•12. Subjects smoking more than 10 cigarettes/ day
•13. Subjects consuming more than 20g alcohol/ day
•14. Subjects who are unlikely to comply with Protocol requirements e.g. uncooperative attitude, subjects who are frequent travellers, inability to return for the visits
•15. Subject participating in any other clinical trial.

发起方

Spectrum Clinical Research Pvt Ltd