Effect of Oats on Lipid Profile

Mildly Hypercholesterolemic Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02376660
• Other study ID #: PEP-1205
• Status: Completed
• Phase: N/A
• First received: February 25, 2015
• Last updated: February 25, 2015
• Start date: December 2012
• Est. completion date: August 2013

Study information

• Verified date: February 2015
• Source: PepsiCo Global R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Mildly Hypercholesterolemic Subjects

Intervention

Other:
• Oats

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
PepsiCo Global R&D

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction of total cholesterol		4 weeks	No
Secondary	LDL-c		4 weeks	No
Secondary	Triglycerides		4 weeks	No
Secondary	Blood pressure		4 weeks	No