To determine the safety and efficacy of Lycopene powder in healthy adult subjects

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Lycopene 20% powder (a standardized Solanum lycopersicum extract) in Healthy Adult Subjects. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079658

Enrollment

Registered

2025-01-28

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

None listed

Interventions

Intervention1: Lycopene 20% powder: 250 mg capsule containing 125 mg of Lycopene 20% powder Control Intervention1: Placebo: placebo capsule-250 mg

Eligibility

Inclusion criteria

Inclusion criteria: 1) Male and female subjects aged 40-70 years. 2) Participants at risk for cardiovascular disease, as indicated by one or more of the following: • Elevated LDL cholesterol levels (= 120 mg/dL to =160 mg/dL). 3) Participants must be on a stable medication regimen for at least 3 months prior to the study, if applicable. 4) Participants with BMI 18.5-24.9kg/m2. 5) Individuals must be able and willing to provide informed consent. 6) Individuals must be able to comply with the study protocol and procedures.

Exclusion criteria

Exclusion criteria: 1) Subjects with a history of hypersensitivity to lycopene. 2) Subjects with a BMI =25 kg/m2 3) Subjects with a family history of hypercholesterolemia 4) Current use of any supplement, herbal products or drugs for the management of hyperlipidaemia. 5) Presence of significant liver or renal disease. 6) History of major cardiovascular events (e.g., myocardial infarction, stroke) within the last 6 months. 7) Active malignancy or history of cancer within the last 5 years. 8) Pregnant or lactating women, and women of childbearing potential not using adequate contraceptive measures or found positive for a urine pregnancy test. 9) Participation in another clinical trial within 30 days prior to study entry.

Design outcomes

Primary

Measure	Time frame
Mean change in serum levels of LDL.Timepoint: Baseline, Day 42, Day 84	—

Secondary

Measure	Time frame
1) Change in serum levels of total cholesterol, HDL cholesterol and triglyceridesTimepoint: Baseline, Day 42, Day 84;2) Change in the vital signs .Timepoint: Baseline, Day 42, Day 84;3) Change in the safety parameters including Complete Blood Count (CBC), blood Chemistry, thyroid profile, liver function tests (ALT, AST, and bilirubin) and renal function tests (creatinine and BUN)Timepoint: Baseline, Day 84;4) Assessment of tolerability, incidence and severity of adverse events.Timepoint: Day 42 and Day 84	—

Measure

Time frame

1) Change in serum levels of total cholesterol, HDL cholesterol and triglyceridesTimepoint: Baseline, Day 42, Day 84;2) Change in the vital signs .Timepoint: Baseline, Day 42, Day 84;3) Change in the safety parameters including Complete Blood Count (CBC), blood Chemistry, thyroid profile, liver function tests (ALT, AST, and bilirubin) and renal function tests (creatinine and BUN)Timepoint: Baseline, Day 84;4) Assessment of tolerability, incidence and severity of adverse events.Timepoint: Day 42 and Day 84

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Countries

India

Contacts

Public ContactDr Sudeep

Vidya Herbs Pvt Ltd

research@vidyaherbs.com09620384780

Outcome results