Randomised, double-blind, placebo controlled phase II study of the efficacy of Phospha-E biomarkers of inflammation, in patients with metabolic syndrome and mild to moderate hyperlipidemia.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000343404

Enrollment

160

Registered

2007-06-26

Start date

2007-10-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study is for subjects who have a condition called metabolic syndrome. Metabolic syndrome is a condition in which people may have a number of clinically determined symptoms such as abdominal obesity, high cholesterol (lipid) and glucose levels in the blood and high blood pressure, as well as others. Some people may have only some of these clinical symptoms while others may have more. These clinical observations, and the severity of them, are recognised in a number of well known disease states such as cardiovascular disease and diabetes. Vitamin E has been around for decades and is widely used by people for its known antioxidant properties. D-alpha Tocopheryl Phosphate (Phospha-E™) has recently been discovered to be naturally occurring in the body (like vitamin E) and has shown promising effects in laboratory studies on inflammatory markers which are implicated in a number of disease states associated with a condition known as Metabolic Syndrome. The purpose of this study is to see if D-alpha Tocopheryl Phosphate (Phospha-E™) has any effect on your metabolic syndrome. The study would like to determine if D-alpha Tocopheryl Phosphate (Phospha-E™) is able to lower biomarkers such as cholesterol and various inflammatory markers, compared with placebo, a capsule that looks the same as D-alpha Tocopheryl Phosphate (Phospha-E™) but has no active ingredient. These biomarkers are important factors that contribute to the development of metabolic syndrome It is not known whether D-alpha Tocopheryl Phosphate (Phospha-E™) is better than receiving no drug or receiving classical vitamin E, and this is what is to be determined. The study will compare two different doses of the study drug, D-alpha Tocopheryl Phosphate (Phospha-E™) to placebo (an inactive look alike capsule). It will also compare classical vitamin E to placebo.

Interventions

1. Phospha-E - d-tocopheryl phosphate (2 doses 200 and 400IU) 2. Tocopherol Acetate (Cognis product Covitol-700; 1 dose at 200IU) All are admistered orally as 1 capsule daily for 12 weeks.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

35 Years to 60 Years

Healthy volunteers

Inclusion criteria

Caucasians with a waist circumference of >102cm (40 inches) for men and >89cm (35 inches) for women.- plus 2 of the following: - type 2 diabetes (but not on medication) - fasting blood glucose between 6.1-7.0mmol/L. - impaired glucose tolerance, as determined in the preceeding months by a glucose tolerance test. - systolic blood pressure >135mmHg or diastolic blood pressure of >90mmHg. - fasted total cholesterol >5.2mmol/L - fasted triglycerides >1.7mmol/L - fasted LDL >3.4mmol/L - fasted HDL <1.036mmol/L for men and <1.295mmol/L for women. - hsCRP levels >3.0mg/L

Exclusion criteria

Subjects with significant impairment in renal and/or hepatic function as determined through pre-history-driven physical.- Subject has a creatine clearance of <60ml/min determined by Cockcroft-Gault's method.- Subject has had any gastric/bowel surgery.- Subject has known history of allergic responses to vitamin E.- Subject has taken hyperlipidemic, diabetic or hypertensive medication within the last 2 months.- Subject is pregnant or breast-feeding.- Subject has a high white blood cell count (WBC; greater than 15/high power field (hpf).

Outcome results