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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

Tracking Information
First Submitted Date  ICMJE February 25, 2015
First Posted Date  ICMJE March 3, 2015
Last Update Posted Date March 3, 2015
Study Start Date  ICMJE December 2012
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2015)
reduction of total cholesterol [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2015)
  • LDL-c [ Time Frame: 4 weeks ]
  • Triglycerides [ Time Frame: 4 weeks ]
  • Blood pressure [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Oats on Lipid Profile
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Mildly Hypercholesterolemic Subjects
Intervention  ICMJE Other: Oats
Study Arms  ICMJE
  • Experimental: Oats
    70 grams oats
    Intervention: Other: Oats
  • Placebo Comparator: usual diet and exercise
    usual diet and exercise
Publications * Gulati S, Misra A, Pandey RM. Effects of 3 g of soluble fiber from oats on lipid levels of Asian Indians - a randomized controlled, parallel arm study. Lipids Health Dis. 2017 Apr 4;16(1):71. doi: 10.1186/s12944-017-0460-3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2015)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02376660
Other Study ID Numbers  ICMJE PEP-1205
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PepsiCo Global R&D
Study Sponsor  ICMJE PepsiCo Global R&D
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anoop Misra, MD, MBBS Fortis Clinical Research Limited
PRS Account PepsiCo Global R&D
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP