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Effect of Oats on Lipid Profile

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ClinicalTrials.gov Identifier: NCT02376660
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
PepsiCo Global R&D

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.

Condition or disease Intervention/treatment Phase
Mildly Hypercholesterolemic Subjects Other: Oats Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Study Start Date : December 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Arm Intervention/treatment
Experimental: Oats
70 grams oats
Other: Oats
Placebo Comparator: usual diet and exercise
usual diet and exercise



Primary Outcome Measures :
  1. reduction of total cholesterol [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. LDL-c [ Time Frame: 4 weeks ]
  2. Triglycerides [ Time Frame: 4 weeks ]
  3. Blood pressure [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376660


Sponsors and Collaborators
PepsiCo Global R&D
Investigators
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Principal Investigator: Anoop Misra, MD, MBBS Fortis Clinical Research Limited

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: PepsiCo Global R&D
ClinicalTrials.gov Identifier: NCT02376660     History of Changes
Other Study ID Numbers: PEP-1205
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: February 2015