NCT04529174

Oral Nutritional Supplement Effect on HDL Function

Evaluation of an Oral Nutritional Supplement for Effect on Total High-Density Lipoprotein (HDL) Cholesterol, HDL Functionality, Particle Size and Number

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Metagenics, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2020-08-18
• Primary completion: 2021-04-30
• Completion: 2023-12-30
• First posted: 2020-08-27
• Last updated: 2024-03-15

Locations

1 site across 1 country: United States