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Completed

NCT Number: NCT02376660

Effect of Oats on Lipid Profile

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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Key information

Conditions

Mildly Hypercholesterolemic Subjects

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Oats

Other

Primary outcomes

  1. reduction of total cholesterol

    Time frame: 4 weeks

Secondary outcomes

  1. LDL-c

    Time frame: 4 weeks

  2. Triglycerides

    Time frame: 4 weeks

  3. Blood pressure

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 3, 2015
Registry last updated
Mar 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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