Study of dietary fiber to improve lipid profile in patients having dyslipidemia.

Recruiting

• Conditions: Dyslipidemia

• Registration Number: CTRI/2015/04/005726
• Lead Sponsor: Mr Ajay Nilawar

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-30
• Last Update Posted: 2015-05-21

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•To determine the effect on total cholesterol	At screening, week 4 and week 8
•To determine the effect on Triglycerides	At screening, week 4 and week 8

Secondary Outcome Measures

Name	Time	Method
•To determine the effect on HDL cholesterol	•To determine the effect on LDL cholesterol

Trial Locations

Locations (1)

Jehangir Clinical Development Centre Pvt Ltd; 🇮🇳 Pune, MAHARASHTRA, India

Jehangir Clinical Development Centre Pvt Ltd

🇮🇳Pune, MAHARASHTRA, India

Dr Almas Pathan

Principal investigator

91-9763002830

almas.jikare@rediffmail.com