Effect of Oats on Lipid Profile

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Mildly Hypercholesterolemic Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Oats

70 grams oats

Group Type EXPERIMENTAL

Oats

Intervention Type OTHER

usual diet and exercise

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Oats

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No