Vitamin E or Lipoic Acid on Serum Oxyphytosterol Concentrations

NCT01984567 | Unknown

• 1 other identifier: NL40392.068.12 / METC 12-3-047
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oxidative Stress

Keywords

Oxyphytosterols; Oxidative stress; Vitamin E; Lipoic acid

Outcome Measures

Primary Outcomes (1)

• Plasma oxyphytosterol concentrations

  Measured after 4 weeks intervention

Secondary Outcomes (3)

• Serum lipoprotein concentrations

  Measured after 4 weeks intervention

• Markers reflecting oxidative stress

  Measured after 4 weeks intervention

• Markers reflecting antioxidant capacity

  Measured after 4 weeks intervention

Study Arms (3)

Vitamin E

EXPERIMENTAL

Dietary Supplement: Vitamin E

Lipoic acid

EXPERIMENTAL

Dietary Supplement: Lipoic acid

Control

PLACEBO COMPARATOR

Dietary Supplement: Control

Interventions

Vitamin E DIETARY_SUPPLEMENT

Daily consumption of vitamin E capsules, 3 capsules of 268 mg daily, in total daily consumption of 804 mg

Vitamin E

Lipoic acid DIETARY_SUPPLEMENT

Daily consumption of lipoic acid capsules, 3 capsules of 200 mg daily, in total daily consumption of 600 mg

Lipoic acid

Control DIETARY_SUPPLEMENT

Daily consumption of 3 placebo capsules

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Limburg, 6229 ER, Netherlands

Location

MeSH Terms

Interventions

Vitamin E; Thioctic Acid

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• Jogchum Plat, Prof.

  Maastricht University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 8, 2013
• First Posted: November 14, 2013
• Study Start: April 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: November 14, 2013

Record last verified: 2013-11

Locations

NL (1)