None listed
Conditions
Brief summary
In previous studies, we and others have observed that the levels of plasmalogens (a class of phospholipid (blood fat)) are lower in obese people and people with type 2 diabetes and cardiovascular (heart) disease. In one of our studies we have shown that dietary supplementation of alkylglycerol (fats found in the liver of most animals and fish) can increase levels of plasmalogens. This increase is associated with a reduction of athersosclerosis (artery blockage) in mice. In separate experiments, after treating mice on a high fat diet with alkylglycerols, we observed a reduction in the inflammation caused by obesity. In this project we will observe the effect of alkylglycerol (Alkyrol) supplementation (in the form of a capsule) on overweight/obese males. The study will involve a cross-over design, where participants will take a supplement of Alkyrol (shark liver oil capsule) or placebo (dummy capsule) for three weeks, a wash out (no supplementation) period of three weeks and cross over to Alkyrol or placebo for three weeks. Over this time blood will be collected at certain points and then analysed to observe the effect of alkylglycerol on plasmalogens and the effect of inflammation. We will recruit 10 overweight/obese men (Body Mass Index (BMI – a measure of body fat based in relation to your height) of 28-35kg/m2), not being treated for hypertension (high blood pressure), diabetes or cardiovascular (heart) disease or taking any fish oil supplements. This study represents the first proof of concept (demonstration) human trial that alkylglycerols can modify circulating plasmalogen levels and influence inflammation. If positive, this randomised clinical trial will support therapeutic approaches targeting plasmalogen modification for the prevention of type 2 diabetes and cardiovascular disease.
Interventions
In this project we will observe the effect of alkylglycerol (Alkyrol) supplementation (in the form of a capsule) on overweight/obese males. The study will involve a cross-over design, where participants will take a supplement of Alkyrol (shark liver oil capsule) or placebo (dummy capsule) for three weeks, a wash out (no supplementation) period of three weeks and cross over to Alkyrol or placebo for three weeks. Over this time blood will be collected at certain points and then analysed to observe
In this project we will observe the effect of alkylglycerol (Alkyrol) supplementation (in the form of a capsule) on overweight/obese males. The study will involve a cross-over design, where participants will take a supplement of Alkyrol (shark liver oil capsule) or placebo (dummy capsule) for three weeks, a wash out (no supplementation) period of three weeks and cross over to Alkyrol or placebo for three weeks. Over this time blood will be collected at certain points and then analysed to observe the effect of alkylglycerol on plasmalogens and the effect of inflammation. Alkyrol will be administered 2g twice daily, the maximum recommended dose (4g daily). Any unused capsules will be asked to be returned between treatments. Blood tests will be done before and after each treatment arm to monitor participants.
Sponsors
Baker IDI Heart and Diabetes Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
25 Years to 60 Years
Healthy volunteers
Yes
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.
Outcome results
None listed