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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39350
Enrollment
20
Registered
2012-09-07
Start date
2012-10-08
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

increased phytosterol concentrations

Interventions

Subjects will be asked to consume three times daily control capsules, vitamin E capsules (total 804 mg) or lipoic acid capsules (total 600 mg) for three periods of four weeks. They will be asked to

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Aged between 18 and 75 years Body Mass Index (BMI) between 20-35 kg/m2 Mean serum total cholesterol 7.8 mmol/l and

Exclusion criteria

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 (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

Design outcomes

Primary

MeasureTime frame
Blood samples will be drawn at week 1, 3 and 4 of each test period. The samples will be analysed for serum / plasma concentrations of plant sterols and oxyphytosterols.

Secondary

MeasureTime frame
Samples will also be analysed for oxidative stress markers, antioxidant capacity, lipoproteins, and for markers reflecting low-grade systemic inflammation and endothelial dysfunction.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)