Effect of Oats on Lipid Profile

Not Applicable

Completed

• Conditions: Mildly Hypercholesterolemic Subjects
• Interventions: Other: Oats

• Registration Number: NCT02376660
• Lead Sponsor: PepsiCo Global R&D

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2015-02
• Study First Submitted: 2015-02-25
• Study First Submitted QC: 2015-02-25
• Last Update Submitted: 2015-02-25
• Study First Posted: 2015-03-03
• Last Update Posted: 2015-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oats	Oats	70 grams oats

Primary Outcome Measures

Name	Time	Method
reduction of total cholesterol	4 weeks

Secondary Outcome Measures

Name	Time	Method
Blood pressure	4 weeks
LDL-c	4 weeks
Triglycerides	4 weeks