Clinical study of nutritional product in the participant in managing high cholesterol.

Phase 2

• Conditions: Health Condition 1: E785- Hyperlipidemia, unspecified

• Registration Number: CTRI/2024/07/069846
• Lead Sponsor: ife Synergy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Male and females aged 30 to 60 years both inclusive; 2.Clinically diagnosed with dyslipidemia, must exhibit specific fasting lipid profiles, meeting the following thresholds: 1.Fasting total cholesterol concentration 200 to 300 mg per dL 2.Fasting triglyceride concentration 150 to 250 mg per dL 3.Fasting LDL cholesterol concentration greater than 100 mg per dL 4.Fasting VLDL cholesterol concentration greater than 30 mg per dL 3.Participants with or without concomitant statin therapy; 4.Willing and able to follow dietary and lifestyle recommendations; 5.Participants with BMI 26 to 30 kg/m2 at screening; 6.Participants providing voluntary, written informed consent to participate in the study.

Exclusion Criteria

1.Pregnancy or lactation,

2.Presence of any significant comorbid condition like hypertension, diabetes,

3.Unstable angina, myocardial infarction or stroke within 3 months,

4.Body mass index (BMI) greater than 30 kg per meter square,

5.Severe liver disease (Child Pugh Class C) or ALT AST more than 3 times upper limit of normal (ULN),

6.Severe renal impairment (GFR less than 30 ml per min),

7.History of cancer within 5 years (except non melanoma skin cancer),

8.K C O uncontrolled hypothyroidism (TSH greater than 1.5 times ULN),

9.Demyelinating disorders,

10.Use of fibrates, niacin, fish oils or other lipid altering drugs,

11.Known hypersensitivity to study drug components,

12.Any other clinical condition in the investigators judgment finds the study participation unsuitable for the participant.

Study & Design

• Study Type: Interventional
• Study Design: Not specified