Modulation of Plasmalogens in Human Males using Alkylglycerol

Not Applicable

Completed

• Conditions: Atherosclerosis; Diabetes; Obesity; Cardiovascular - Other cardiovascular diseases; Metabolic and Endocrine - Diabetes; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12615001188527
• Lead Sponsor: Baker IDI Heart and Diabetes Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-04
• Study Completion: 2016-08-08
• Last Update Posted: 16 February 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

Males aged 25-60 years; BMI between 28 and 40 (kg/m2); no evidence of established diabetes or cardiovascular disease. Not on any lipid lowering or antihypertensive medication, not taking any fish oil supplementation; normal liver function; have given signed informed consent to participate in the study.

Exclusion Criteria

Established diabetes or cardiovascular disease, on any prescription medication, fish oil supplements, evidence of liver disease (i.e. cirrhosis or hepatitis) or abnormal liver function defined as aspartate aminotransferase, alanine aminotransferase or total bilirubin >1.5x the upper limit of normal.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Circulating plasmalogens as determined by mass spectrometric analysis of plasma[The study is a cross over, double blind placebo controlled study design. Circulating plasmalogens will be measured one day before and one day after each treatment period (placebo and alkylglycerol) as well as at recruitment. In total five measurements of circulating plasmalogens will be made. <br> ]

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes of the effect of alkylglycerol are; plasma lipids (total cholesterol, HDL-C, LDL-C, triglycerides.[Secondary outcome variables will be measured one day before and one day after each treatment period (placebo and alkylglycerol) as well as at recruitment. In total five measurements of secondary outcome variables will be made. ];fasting plasma glucose[one day before and one day after each treatment period];Plasma oxidiative markers (TBARS, thiobarbituric acid reactive substances)[One day before and one day after each treatment period];Plasma inflammatory markers (hsCRP, MCP-1, VCAM-1 and TNF-alpha) [One day before and one day after each treatment period];Full lipidomic profile of plasma. Performed by mass spectrometric analysis of over 400 plasma lipids using only 10 uL plasma.[One day before and one day after each treatment period]