Effect of Oats on Lipid Profile

A Randomized Controlled Trial to Evaluate the Efficacy of 3 g of Soluble Fiber From Oats on the Lipid Profile of Men and Women With Elevated Lipid Levels Aged Between 20 and 50 Years

A randomized control trial to assess the effect of oats on lipid profile of mildly hypercholesterolemic subjects. Subjects consumed 35g of oats twice daily (total of 70g / day) in place of carbohydrates as part of their usual diet. 70 grams of oats provide 3 grams of soluble fiber. Control group consumed the usual diet. Subjects followed up for 4 weeks. In total 3 assessment visits of the subjects planned for the study period.

Inclusion Criteria:

• Men and women between 20 and 50 years old
• Total Cholesterol: ≥ 200 mg/dL and < 240mg/dL
• Availability and willingness to follow study protocol
• Stable body weight for previous 3 months (not more than 5% weight change)

Exclusion Criteria:

• Subjects already on lipid lowering drugs
• LDL-c > 190 mg/dL
• Total cholesterol <200 mg/dL and >240 mg/dL
• Subjects with serum creatinine levels > 1.3 mg/dL (female) or 1.4 mg/dL (male), nephropathy, evidence of hepatic disease or history of alcohol abuse
• Baseline Triglycerides: > 300 mg/dL
• Diabetes (Type 1 or Type 2) as diagnosed by a physician
• Uncontrolled hyperthyroidism (as per physician's discretion)
• Uncontrolled hypertension (as per physician's discretion)
• Acute infections or chronic debilitating diseases like tuberculosis, malignancy, HIV infection etc. Any life threatening serious disorder of the liver, kidneys, heart, lungs or other organs by history
• Irritable bowel syndrome by history
• Unwillingness to give written informed consent for participation in the study.
• Pregnancy & lactation (by history)
• Severe end organ damage
• Subjects with allergy to oats
• Heavy smokers (smoking more than 5 cigarettes per day)