Clinical Study to Evaluate the Benefits of Saffola Oats with Diet & Exercise in Improving Cardiovascular Health on Normolipidemic Individuals

Not Applicable

Completed

• Registration Number: CTRI/2010/091/006124
• Lead Sponsor: Spectrum Clinical Research Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measures consist of improvements in Direct LDL compared to the respective basal reading.Timepoint: day 30 and Day 60

Secondary Outcome Measures

Name	Time	Method
The secondary outcome measures consist of improvements in: <br/ ><br>1) In the Lipid Profile, includes Total Cholesterol, HDL VLDL compared to the respective basal reading. <br/ ><br>2) Fasting & postprandial TG. <br/ ><br>3) On physical fitness parameters (weight reduction). <br/ ><br>4) In fasting and postprandial blood glucose response, satiety and quality of life parameters (general well being, digestion, immunity, memory retention and concentration) day 30 and Day 60 compare to the respective basal reading.Timepoint: day 30 and Day 60