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Oral Nutritional Supplement Effect on HDL Function

NCT04529174 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2024-03-15

No results posted yet for this study

Summary

Evaluate the effects of a proprietary supplement on total HDL, HDL functionality, HDL particle size and HDL particle number (HDL-P)

Conditions

  • HDL

Interventions

DIETARY_SUPPLEMENT

CardioLux™HDL

Enrollment will occur according to the inclusion/ exclusion criteria and after the review and signing of the Informed Consent form. Clinical testing will be performed at baseline and each visit (2, 3). Measurement of height, weight with body composition analysis, body mass index, waist circumference, and vital signs (blood pressure, heart rate) will be measured. Review of medical history and current medications by clinician; and collection of fasting blood for testing of the complete blood count (CBC), comprehensive metabolic profile (CMP), as well as a urine pregnancy test in females of child-bearing potential. Visits: Baseline (Visit 1), Week 6 (Visit 2) and Week 12 (Visit 3/End of Study)

DIETARY_SUPPLEMENT

Placebo

Enrollment will occur according to inclusion /exclusion criteria and after the review and signing of the Informed Consent form. Clinical testing will be performed at baseline and each visit (2, 3). Measurement of height, weight with body composition analysis, body mass index, waist circumference, and vital signs (blood pressure, heart rate) will be measured. Review of medical history and current medications by clinician; and collection of fasting blood for testing of the complete blood count (CBC), comprehensive metabolic profile (CMP), as well as a urine pregnancy test in females of child-bearing potential. Visits: Baseline (Visit 1), Week 6 (Visit 2) and Week 12 (Visit 3/End of Study)

Sponsors & Collaborators

  • Metagenics, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Houston, MD · Hypertension Institute

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-18
Primary Completion
2021-04-30
Completion
2023-12-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04529174 on ClinicalTrials.gov