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Search / Trial NCT03425630

LDL-cholesterol Lowering Effect of a New Dietary Supplement

Launched by ISPHARM SRL · Feb 1, 2018

Trial Information

Current as of October 29, 2025

Completed

Keywords

ClinConnect Summary

Between July 2016 and April 2017 eligible patients were recruited among the outpatients attending the Obesity Center of the Endocrinology Unit 1, Cisanello Hospital, Pisa, Italy. Patients aged 18-75 years with serum LDL-C between130-180 mg/dL, not significantly modified by an appropriate dietetic regimen were considered eligible for the study. Thirty patients, all Caucasian, were screened. Ten were excluded during the screening process because they did not fulfill all the inclusion criteria (screening failure). Twenty patients were thus randomized, 10 to the A\>N sequence and 10 to the N\>A...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • serum LDL-C between130-180 mg/dL, not significantly modified by an appropriate dietetic regimen
  • Exclusion Criteria:
  • pregnancy or breast-feeding
  • known liver, renal or muscle diseases
  • serum triglycerides (TG) greater than 350 mg/dL
  • previous cardiovascular events
  • concomitant neoplastic or immunodepressive disease
  • use of lipid-lowering drugs or dietary supplements within the last 3 weeks
  • concurrent use of thiazide diuretics, oral contraceptives containing estrogen or progestogen, systemic corticosteroids
  • use of psycho-active substances, drug or alcohol abuse
  • neurological or psychiatric diseases that could affect consent validity or impair the patient's adherence to the study protocol

About Ispharm Srl

ispharm srl is a leading clinical trial sponsor dedicated to advancing pharmaceutical research and development. With a focus on innovative therapies and personalized medicine, ispharm srl partners with academic institutions, healthcare providers, and regulatory bodies to conduct rigorous clinical trials that adhere to the highest ethical and scientific standards. The company leverages its extensive expertise in clinical operations, data management, and regulatory compliance to facilitate the efficient and timely progression of drug development, ultimately aiming to improve patient outcomes and enhance public health.

Locations

Patients applied

0 patients applied

Trial Officials

Ferruccio Santini, Prof.

Principal Investigator

Endrinology Unit 1; Cisanello Hospital, Pisa (Italy)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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