Effect of omega-3 fatty acid on metabolic syndrome

Not Applicable

• Conditions: Health Condition 1: E889- Metabolic disorder, unspecifiedHealth Condition 2: null- Subjects with signs and symptoms of metabolic syndrome

• Registration Number: CTRI/2018/05/013548
• Lead Sponsor: izams Institute of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Male and female subjects between 30-65 years and willing to give informed consent and comply with protocol related study procedures.

2.Subjects having endothelial dysfunction defined as � 6% change in reflection index (RI) on post salbutamol challenge test.

3. Subjects who comply with ââ?¬Å?The International Diabetes Federationââ?¬? guidelines dated 2006

4. Subjects not on any investigational products in the past 6 months.

Exclusion Criteria

1.Subjects with abnormal hematological or biochemical parameters considered significant by investigator.

2.Uncontrolled hypertension ( SBP >180mmHg and DBP >100mmHg).

3.Serum Triglycerides >500mg/dl.

4.AST and ALT elevation >3 times upper limit of normal.

5.Serum creatinine more than 1.5 mg/dl.

6.On any other dietary or herbal supplements.

7.History of malignancy or stroke.

8.Smoking, chronic alcoholism.

9.Any medical condition where physician feels participation in the study could be detrimental to subjects well being.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in endothelial dysfunction as assessed by more than 6% change in reflection index in all the treatment groups.Timepoint: Change in endothelial dysfunction as assessed by more than 6% change in reflection index at 12 weeks in all the treatment groups.

Secondary Outcome Measures

Name	Time	Method
Subjects with abnormal hematological or biochemical parameters considered significant by investigator. <br/ ><br>Uncontrolled hypertension (SBP180mmHg and DBP100mmHg). <br/ ><br>Serum Triglycerides 500mg/dl. <br/ ><br>AST and ALT elevation 3 times upper limit of normal. <br/ ><br>Serum creatinine more than 1.5 mg/dl. <br/ ><br>On any other dietary or herbal supplements. <br/ ><br>History of malignancy or stroke. <br/ ><br>Smoking,chronic alcoholism. <br/ ><br>Timepoint: 0, 4, 8, 12 weeks