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.

Study Overview

• Status: Completed
• Conditions: Mildly Hypercholesterolemic Subjects
• Intervention / Treatment: Other: Oats

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oats; 70 grams oats	Other: Oats
Placebo Comparator: usual diet and exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
reduction of total cholesterol	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Blood pressure	4 weeks
Triglycerides	4 weeks
LDL-c	4 weeks

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Investigators: Principal Investigator: Anoop Misra, MD, MBBS, Fortis Clinical Research Limited

Publications and helpful links

General Publications

• Gulati S, Misra A, Pandey RM. Effects of 3 g of soluble fiber from oats on lipid levels of Asian Indians - a randomized controlled, parallel arm study. Lipids Health Dis. 2017 Apr 4;16(1):71. doi: 10.1186/s12944-017-0460-3.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: February 25, 2015
• First Submitted That Met QC Criteria: February 25, 2015
• First Posted (Estimate): March 3, 2015

Study Record Updates

• Last Update Posted (Estimate): March 3, 2015
• Last Update Submitted That Met QC Criteria: February 25, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: PEP-1205