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

Not Applicable

Completed

• Conditions: Health Condition 1: null- Hyperlipidemia

• Registration Number: CTRI/2010/091/006115
• 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

2 LDL Cholesterol in between 130 - 190 mg %

3 BMI 23 - 30 kg/m2

4 Patient is clinically stable and all laboratory investigations are clinically acceptable as per P.I Discretion

Exclusion Criteria

1. BMI > 30 kg/m2
2. Patients suffering from any 1 of the following diseases that can be considered
as a risk factor‐ Diabetes, CAD, CVD, Coronary Artherosclerosis and uncontrolled hypertension.
3. Patient undergone coronary artery bypass graft (CABG) or any other major cardiac surgery.
4. Patients taking lipid lowering drugs including Simvastatin, Pravastatin,Fluvastatin, Atorvastatin, Cerivastatin, Rosuvastatin etc.
5. Patients with blood pressure > 140/90 mmHg
6. Patients with clinical signs and symptoms of liver, kidney or thyroid disorders.
7. Patients having TB
8. Pregnant and lactating women
9. Oat users
10. Patients having known hypersensitivity to Oats or Oats products.
11. Patients who has a fiber intake > 25 g/day
12. Patients who are on caloric reduction diet/ change dietary constituents frequently
13. Athletes or Patients who do any form of exercise everyday (jogging, brisk walking, swimming, weight lifting etc.)
14. Patients smoking more than 10 cigarettes/ day
15. Patients consuming more than 20g alcohol/ day
16. Patients who are unlikely to comply with Protocol requirements e.g. uncooperative attitude, patients who are frequent travellers, inability to return for the visits
17. Patient participating in any other clinical trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified