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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02376660

Enrollment

Registered

2015-03-03

Start date

2012-12-31

Completion date

2013-08-31

Last updated

2015-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mildly Hypercholesterolemic Subjects

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.

Interventions

OTHEROats

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

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)

Design outcomes

Primary

Measure	Time frame
reduction of total cholesterol	4 weeks

Secondary

Measure	Time frame
LDL-c	4 weeks
Triglycerides	4 weeks
Blood pressure	4 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026