Health Condition 1: null- Dyslipidemia
Conditions
Interventions
Intervention1: Dietary Fiber: It is a sachet of 5gms. It is to be dissolved in a glass of water and to be taken with meals.
Dose: 5 grams twice daily for duration of 8 weeks.(Subject will be instructe
Sponsors
Mr Ajay Nilawar
Eligibility
Inclusion 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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢To determine the effect on total cholesterol â?¢To determine the effect on Triglycerides Timepoint: At screening, week 4 and week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ To determine the effect on HDL cholesterol â?¢ To determine the effect on LDL cholesterol Timepoint: At screening, week 4 and week 8 | — |
Countries
India
Contacts
Public ContactDr Almas Pathan
Jehangir Clinical Development Centre Pvt Ltd
Outcome results
None listed