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Effect of omega-3 fatty acid on metabolic syndrome

Evaluation of the effect of omega-3 fatty acid alone and in combination with Proprietary Chromium Complex (PCC) 200mcg and 400mcg on endothelial dysfunction in metabolic syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/05/013548
Enrollment
60
Registered
2018-05-01
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Two soft gelatin capsules of Product B once a day, each capsule containing 1000 mg of a refined fish oil concentrate containing 300 mg of eicosapentaenoic acid (EPA) (TG) and 200 mg of

Sponsors

Nizams Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

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 ââ?°Â¤ 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

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.

Design outcomes

Primary

MeasureTime frame
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

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

Countries

India

Contacts

Public ContactDr P Usharani

Nizams Institute of Medical Sciences

ushapingali@yahoo.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026