Health Condition 1: null- Hyperlipidemia
Conditions
Interventions
Intervention1: Saffola Oats: Saffola oats 32g to be consumed 2 times/day hence,subject has to
consume 64g of Saffola oats per day.
Control Intervention1: Nil: Nil
Sponsors
Spectrum Clinical Research Pvt Ltd
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measures consist of improvements in Direct LDL compared to the basal reading.Timepoint: day 30, 60, 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) In the Lipid Profile, includes Total Cholesterol, HDL and VLDL compared to the basal reading. 2) Fasting & postprandial TG. 3) On physical fitness parameters (weight reduction). 4) In other physical parameters, fasting and postprandial blood glucose response, immunity, satiety and quality of life parameters (general well being, digestion, immunity, memory retention and concentration) at day 30, 60, 90 compare to the basal reading.Timepoint: day 30, 60, 90 | — |
Countries
India
Contacts
Public ContactDr Viral Shah
Spectrum Clinical Research Pvt. Ltd.
Outcome results
None listed