The effects of consumption of vitamin E or lipoic acid on serum oxyphytosterol concentrations in subjects with impaired glucose tolerance or type II diabetes

Completed

Conditions: increased phytosterol concentrations
10013317

Registration Number: NL-OMON39350

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Aged between 18 and 75 years
Body Mass Index (BMI) between 20-35 kg/m2
Mean serum total cholesterol <8.0 mmol/L
Mean serum triacylglycerol <3.0 mmol/L
Diagnosed with diabetes mellitus type 2 on a clinical basis or impaired glucose tolerance (defined as blood glucose >7.8 mmol/l and <11.0 mmol/L, two hours after ingesting 75 gram glucose in 150 ml water)

Exclusion Criteria

Unstable body weight (weight gain or loss > 3 kg in the past two months)
Active cardiovascular diseases like congestive heart failure or recent (<6 months) event (acute myocardial infarction, cerebral vascular incident)
Severe medical conditions that might interfere with the study such as epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel disease and rheumatoid arthritis
Use of medication such as corticosteroids, diuretics or lipid lowering therapy
Use of insulin therapy
Abuse of drugs or alcohol (>21 units per week)
Not willing to stop the consumption of vitamin supplements, containing lipoic acid and/or vitamin E, 1 month before the start of the study (wash-in period)
Use of an investigational product within another biomedical study within the previous month
Pregnant or breast-feeding women
Current smoker

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Blood samples will be drawn at week 1, 3 and 4 of each test period. The samples<br /><br>will be analysed for serum / plasma concentrations of plant sterols and<br /><br>oxyphytosterols. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Samples will also be analysed for oxidative stress markers, antioxidant<br /><br>capacity, lipoproteins, and for markers reflecting low-grade systemic<br /><br>inflammation and endothelial dysfunction.</p><br>