Vitamin E or Lipoic Acid on Serum Oxyphytosterol Concentrations

Oxidative Stress Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01984567
• Other study ID #: NL40392.068.12 / METC 12-3-047
• Status: Active, not recruiting
• Phase: N/A
• First received: November 8, 2013
• Last updated: November 8, 2013
• Start date: April 2013
• Est. completion date: January 2014

Study information

• Verified date: November 2013
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Oxidative Stress

Intervention

Dietary Supplement:
• Vitamin E
Daily consumption of vitamin E capsules, 3 capsules of 268 mg daily, in total daily consumption of 804 mg
• Lipoic acid
Daily consumption of lipoic acid capsules, 3 capsules of 200 mg daily, in total daily consumption of 600 mg
• Control
Daily consumption of 3 placebo capsules

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma oxyphytosterol concentrations		Measured after 4 weeks intervention	No
Secondary	Serum lipoprotein concentrations		Measured after 4 weeks intervention	No
Secondary	Markers reflecting oxidative stress		Measured after 4 weeks intervention	No
Secondary	Markers reflecting antioxidant capacity		Measured after 4 weeks intervention	No