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

Not Applicable

• Conditions: Chronic Smokers; Hyperlipidemia
• Interventions: Other: Placebo; Dietary Supplement: BioTurmin (Curcuma longa rhizomes extract); Dietary Supplement: BioTurmin-WD (Water dispersible curcuminoids); Dietary Supplement: MaQxan (Tagetes erecta flower extract)

• Registration Number: NCT02100202
• Lead Sponsor: Olive Lifesciences Pvt Ltd

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 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 30 days. The efficacy of the supplements will be measured by estimating cotinine and malondialdehyde level.

Study Timeline

• Status Verified: 2014-03
• Study First Submitted: 2014-03-22
• Study First Submitted QC: 2014-03-26
• Last Update Submitted: 2014-03-26
• Study First Posted: 2014-03-31
• Last Update Posted: 2014-03-31
• Study Start: 2014-04
• Primary Completion: 2014-07
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Capsules containing 250 mg of placebo, two times a day
BioTurmin	BioTurmin (Curcuma longa rhizomes extract)	Capsules containing 250 mg of BioTurmin (Curcuma longa rhizomes extract), two times a day
BioTurmin-WD	BioTurmin-WD (Water dispersible curcuminoids)	Capsules containing 250 mg of BioTurmin-WD (water dispersible curcuminoids), two times a day
MaQxan	MaQxan (Tagetes erecta flower extract)	Capsules containing 10 mg of MaQxan (Tagetes erecta flower extract), two times a day

Primary Outcome Measures

Name	Time	Method
Change in urine cotinine and serum oxidative stress marker levels	Baseline and on day 30	nicotine metabolite (cotinine) and serum oxidative stress marker (malondialdehyde) levels

Secondary Outcome Measures

Name	Time	Method
Change in serum lipid profile	Baseline and on day 30	Low density lipoprotein-cholesterol (LDL-C), very low density lipoprotein-cholesterol (VLDL-C), high density lipoprotein-cholesterol (HDL-C), total cholesterol (TC)

Trial Locations

Locations (1)

Sreenivasa Clinic Diabetic Research Center; 🇮🇳 Bangalore, Karnataka, India