Efficacy and Safety Study of Dietary Supplements in Chronic Smokers Having Mild to Moderate Hyperlipidemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the efficacy and safety of dietary supplements (BioTurmin, BioTurmin-WD and MaQxan) on cotinine level and oxidative stress marker in chronic smokers having mild to moderate hyperlipidemia after 30 and 60 days of intervention.

Detailed Description
-----------------
In a randomized, double-blind, placebo control trial, the efficacy and safety of dietary supplements (BioTurmin, BioTurmin-WD and MaQxan) will be investigated in chronic smokers having mild to moderate hyperlipidemia. Sixty subjects will be randomly assigned to receive the dietary supplements and placebo for 60 days. The efficacy of the supplements will be measured by estimating cotinine and malondialdehyde level.

Official Title
-----------------
Efficacy and Safety Study of Dietary Supplements (BioTurmin, BioTurmin-WD and MaQxan) on Cotinine Level and Oxidative Stress Marker in Chronic Smokers Having Mild to Moderate Hyperlipidemia

Conditions
-----------------
Chronic Smokers, Hyperlipidemia

Intervention / Treatment
-----------------
* Dietary Supplement: Placebo
* Dietary Supplement: BioTurmin (Curcuma longa rhizomes extract)
* Dietary Supplement: BioTurmin-WD (Water dispersible curcuminoids)
* Dietary Supplement: MaQxan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men > 20 years Chronic cigarette/ beedi smoker (2-3 packets/day since last 3 years or more) with mild to moderate hyperlipidemia (LDL ranging 160-189 mg/dL, TC >200 mg/dL and/or HDL-C <40 mg/dL) Being mentally competent and able to understand all study requirements and sign the informed consent form. Exclusion Criteria: Patients with Chronic obstructive pulmonary disease (COPD) Women Patients with severe liver, renal, cardiac or brain diseases. Unable to complete follow up. Subjects on any medication like diuretics. Allergic to any medication. With a history of alcohol and/or drug abuse.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Capsule containing 250 mg of placebo, two times a day | Dietary Supplement: Placebo<br> <br> |
| Experimental: BioTurmin<br>Capsule containing 250 mg of BioTurmin (Curcuma longa rhizomes extract), two times a day | Dietary Supplement: BioTurmin (Curcuma longa rhizomes extract)<br> <br> |
| Experimental: BioTurmin-WD<br>Capsule containing 250 mg of BioTurmin-WD (water dispersible curcuminoids), two times a day | Dietary Supplement: BioTurmin-WD (Water dispersible curcuminoids)<br> <br> |
| Experimental: MaQxan<br>Capsule containing 10 mg of MaQxan (Tagetes erecta flower extract), two times a day | Dietary Supplement: MaQxan<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in urine cotinine and serum oxidative stress marker (malondialdehyde) level |  | Baseline, on day 30 and on day 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum lipid profile | Low density lipoprotein-cholesterol (LDL-C), very low density lipoprotein-cholesterol (VLDL-C), high density lipoprotein-cholesterol (HDL-C), total cholesterol (TC) | Baseline, on day 30 and on day 60 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dietary supplements, Cotinine level, Malondialdehyde, Chronic smokers, Hyperlipidemia