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
1 other identifier
interventional
80
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2012
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 25, 2015
CompletedFirst Posted
Study publicly available on registry
March 3, 2015
CompletedMarch 3, 2015
February 1, 2015
8 months
February 25, 2015
February 25, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
reduction of total cholesterol
4 weeks
Secondary Outcomes (3)
LDL-c
4 weeks
Triglycerides
4 weeks
Blood pressure
4 weeks
Study Arms (2)
Oats
EXPERIMENTAL70 grams oats
usual diet and exercise
PLACEBO COMPARATORusual diet and exercise
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 28376899DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Anoop Misra, MD, MBBS
Fortis Clinical Research Limited
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2015
First Posted
March 3, 2015
Study Start
December 1, 2012
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
March 3, 2015
Record last verified: 2015-02