CTRI/2015/04/005726RecruitingNot Applicable
A clinical study to determine the effect of a dietary fiber on lipid profile in patients with Dyslipidemia.
Mr Ajay Nilawar1 site in 1 country30 target enrollmentStarted: April 30, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- •To determine the effect on total cholesterol
Study Overview
Brief Summary
This is a study in subjects with hypercholesterolemia. The main purpose of this study is to determine the effect of dietary fiber in patients with hyperchloesterolemia. Subjects who have met the eligibility criteria will be enrolled into the study. At the screening visit, retrospective data of subject’s lipid profile (Total cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides) of past 8 weeks will be collected.In addition, Lipid profile will be assessed at screening, week 4/ day 29 and week 8/ day 57.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 20.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Men and women
- •65 years of age (both inclusive). 2.Patients with borderline total cholesterol in the range of 195 to 239 mg/dl at screening. 3.Patients with LDL levels in the range of 100 to 130 mg/dl at screening. 4.Must be willing to or likely to comply with all study requirements. 5.Must be able and willing to provide written informed consent. 6.Females of childbearing potential should have a negative pregnancy test at the time of screening and agree to use contraception during the study.
Exclusion Criteria
- •â€¢History of cardiovascular disease or Diabetes mellitus •Intake of nutritional supplements containing fish oil, soy protein, garlic etc.
- •â€¢Suffering from gastrointestinal diseases that may interfere with nutrient absorption,distribution,metabolism and excretion.eg:Subcaute obstruction •Current use of medication that may interfere with the digestion and nutrient absorption (for examples steroids, protease inhibitors or antipsychotics medications).
- •â€¢Known case of sensitivity to Gluten or Coeliac disease.
- •â€¢Known food allergy or intolerance, abuse of drugs or alcohol •Pregnant or lactating females.
- •â€¢Presence of any clinically significant medical conditions or medications which in the opinion of the investigator would make the subject unsuitable for participation in the study.
- •â€¢Currently participating or had participated in other interventional study in last 1 month prior to screening •Patients who are unlikely to comply with protocol requirements (e.g. non-cooperative behavior, inability to attend study visits required by the protocol).
Outcomes
Primary Outcomes
•To determine the effect on total cholesterol
Time Frame: At screening, week 4 and week 8
•To determine the effect on Triglycerides
Time Frame: At screening, week 4 and week 8
Secondary Outcomes
- •To determine the effect on HDL cholesterol(•To determine the effect on LDL cholesterol)
Investigators
Study Sites (1)
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