Effect of Oats on Lipid Profile

PepsiCo

Status

Completed

Conditions

Mildly Hypercholesterolemic Subjects

Treatments

Other: Oats

Study type

Interventional

Funder types

Industry

Identifiers

NCT02376660

PEP-1205

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

20 to 50 years old

Volunteers

No Healthy Volunteers

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)