NCT02349555

Nutritional Supplement Impact on Metabolic Parameters

An Open-Label Single-Center Study to Determine Safety and Effects of Novel Nutritional Blend on Inflammatory Balance Markers and Metabolic Parameters

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Pharmanex · Industry
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This open label study seeks to study the effects of a nutritional supplement on inflammatory markers, metabolic parameters, and safety in subjects compared to baseline after taking supplement for 2 and 4 months.

Detailed description

Primary endpoint will be to determine if nutritional supplement decreases the metabolic parameter of triglycerides. Numerous studies have demonstrated the efficacy of fish oil on reducing triglycerides in subjects taking fish oil at similar doses provided in our product (see references). Additional metabolic parameters will be measured as secondary endpoints, including abdominal obesity, HDL cholesterol, blood pressure, fasting glucose, haemoglobin A1c, skin glycation (AGEs), pulse wave velocity, skin carotenoids, serum 25(OH)D concentrations, weight, and LDL density, particle size and number. The novel nutritional supplement contains many nutrients that have been shown to improve metabolic parameters.

Conditions

• Other Endocrine/Nutritional/Metabolic Disorder

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutritional Supplement Blend	It is to be taken orally at a dose of 4 capsules per day, 2 capsules with breakfast and 2 capsules with dinner.

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2015-01-29
• Last updated: 2016-09-27

Locations

2 sites across 1 country: United States