Overview

This trial is active, not recruiting.

Condition oxidative stress
Treatments vitamin e, lipoic acid, control
Sponsor Maastricht University Medical Center
Collaborator ZonMw: The Netherlands Organisation for Health Research and Development
Start date April 2013
End date January 2014
Trial size 20 participants
Trial identifier NCT01984567, NL40392.068.12 / METC 12-3-047

Summary

Background of the study:

We now know that plant sterols can oxidize, which results in the formation of oxyphytosterols. Animal studies have suggested that oxyphytosterols are atherogenic components, however this relation has not yet been studied in humans. In our previous study (METC 09-3-088) we have shown in healthy volunteers that serum oxyphytosterol concentrations are linked to oxidative stress status (i.e. we were able to identify high and low sterol oxidizers). From the literature is known that especially type II diabetics and IGT subjects are characterized by increased oxidative stress markers and reduced antioxidant capacity. For this reason we also want to evaluate the oxyphytosterol concentrations in this population. Moreover, we know propose to evaluate the effect of antioxidant supplementation, i.e. vitamin E or lipoic acid, on serum oxyphytosterol concentrations in type II diabetic patients. If possible to lower oxyphytosterol concentrations in these populations this is obviously beneficial in case oxyphytosterols turn out to be atherogenic. The major objective of the present study is to examine the effect of consuming vitamin E (804 mg) or lipoic acid (600 mg) for 4 weeks on fasting oxyphytosterol concentrations in subjects with impaired glucose tolerance or type 2 diabetes.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
vitamin e
Daily consumption of vitamin E capsules, 3 capsules of 268 mg daily, in total daily consumption of 804 mg
(Experimental)
lipoic acid
Daily consumption of lipoic acid capsules, 3 capsules of 200 mg daily, in total daily consumption of 600 mg
(Placebo Comparator)
control
Daily consumption of 3 placebo capsules

Primary Outcomes

Measure
Plasma oxyphytosterol concentrations
time frame: Measured after 4 weeks intervention

Secondary Outcomes

Measure
Serum lipoprotein concentrations
time frame: Measured after 4 weeks intervention
Markers reflecting oxidative stress
time frame: Measured after 4 weeks intervention
Markers reflecting antioxidant capacity
time frame: Measured after 4 weeks intervention

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title The Effects of Consumption of Vitamin E or Lipoic Acid on Serum Oxyphytosterol Concentrations in Subjects With Impaired Glucose Tolerance or Type II Diabetes
Principal investigator Jogchum Plat, Prof.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Maastricht University Medical Center.