CTRI/2015/04/005726
Recruiting
未知
A clinical study to determine the effect of a dietary fiber on lipid profile in patients with Dyslipidemia.
Mr Ajay Nilawar0 sites30 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Mr Ajay Nilawar
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Men and women 20 \- 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
- •History of cardiovascular disease or Diabetes mellitus
- •Intake of nutritional supplements containing fish oil, soy protein, garlic etc.
- •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).
- •Known case of sensitivity to Gluten or Coeliac disease.
- •Known food allergy or intolerance, abuse of drugs or alcohol
- •Pregnant or lactating females.
- •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.
- •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
Not specified
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