Health Condition 1: null- Dyslipidemia
Conditions
Interventions
Intervention1: Fenugreek and wheat powder: Sachet of 5gm/day for first 5 days and 10gm/day from day 6 to 60.
Control Intervention1: Nil: Nil
Sponsors
Spectrum Clinical Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.LDL levels (>= 130 mg/dL and 2.Baseline Triglycerides in the range of > 150mg/dL and 3.Subject is clinically stable as per P.I. discretion. 4.Type 2 diabetes (diagnosed with type 2 diabetes for at least six (6) months and currently controlling their blood glucose levels using stable oral hypoglycaemic agents) 5.Fasting blood glucose values up to 140 mg/dL and PP > 140 mg/dL. 6.Patient with body mass index of >18.5kg/m 2 and 7.Willing to take the dietary fibre as prescribed and sign an inform consent document for participation in the study.
Exclusion criteria
Exclusion criteria: 1.Subjects on lipid lowering drugs. 2.Diabetic (Type1). 3.HbA1c > 7.5 % 4.Patients in the last one month with A)any major illness requiring hospitalization B)acute exacerbation of any ongoing chronic medical illness e.g. Congestive cardiac failure, Hepatitis, Hypotensive episodes, etc. Medications requiring change of doses for treatment of the chronic illness 5.Patients suffering from severe cardiac, renal, liver or any other organ impairment. 6.History of seizures, epilepsy or any neurological disorders. 7.Use of any recreational drug or a history of drug addiction. 8.Patients taking laxatives more than twice a month & /or for last 3 months 9.Patients smoking more than 10 cigarettes/day 10.Patients consuming more than 20 gm alcohol per day 11.Pregnant and lactating women 12.Athletes or patients who do exercises every day 13.Patients who are on caloric reduction diet / change dietary constituents frequently. 14.Patients with auto-immune disorder like Celiac Sprue or Celiac Disease 15.Patients suffering from Mal-Absorption Syndrome 16.Patients who are unlikely to comply with Protocol requirements e.g. uncooperative attitude, patients who are frequent travellers, inability to return for the final visit 17.Patients having Tuberculosis (TB) 18.Patient participating in any other clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the effect of dietary fiber supplement in subjects with elevated LDL levels (â?¥ 130 mg/dL and less than 190mg/dL).Timepoint: 60 Days from Baseline visit | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the efficacy of dietary fiber supplement on following parameters: 1. Triglycerides. 2. Plasma glucose levels. 3. Blood pressure. 4. Quality of life improvementTimepoint: 60 Days from Baseline visit. | — |
Countries
India
Contacts
Public ContactMr Bharani Bhaskar
Spectrum Clinical Research
Outcome results
None listed