Oxidative StressNCT01984567
Vitamin E or Lipoic Acid on Serum Oxyphytosterol Concentrations
A study testing Vitamin E and Lipoic acid in people with Oxidative Stress, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- Vitamin E and Lipoic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, Limburg, 6229 ER
About this study
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
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
- Being tested
- Vitamin E, Lipoic acid, Control
- Keywords
- Oxyphytosterols, Oxidative stress, Vitamin E, Lipoic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin EDietary supplement
Daily consumption of vitamin E capsules, 3 capsules of 268 mg daily, in total daily consumption of 804 mg
Lipoic acidDietary supplement
Daily consumption of lipoic acid capsules, 3 capsules of 200 mg daily, in total daily consumption of 600 mg
ControlDietary supplement
Daily consumption of 3 placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Vitamin E | Experimental | Not described Receives: Dietary Supplement: Vitamin E |
| Lipoic acid | Experimental | Not described Receives: Dietary Supplement: Lipoic acid |
| Control | Placebo comparator | Not described Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma oxyphytosterol concentrations
Measured: Measured after 4 weeks intervention
Secondary outcomes (3)
Serum lipoprotein concentrations
Measured: Measured after 4 weeks intervention
Markers reflecting oxidative stress
Measured: Measured after 4 weeks intervention
Markers reflecting antioxidant capacity
Measured: Measured after 4 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Jogchem Plat, Maastricht University Medical Center
- Investigators
- Jogchum Plat, Prof., Principal investigator, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984567
- Sponsor's protocol ID
- NL40392.068.12 / METC 12-3-047
- Status last verified
- Nov 2013
- First submitted
- 8 Nov 2013
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01984567
- Acronym / sponsor ID
- NL40392.068.12 / METC 12-3-047
- Conditions
- Oxidative Stress
- Keywords
- Oxyphytosterols, Oxidative stress, Vitamin E, Lipoic acid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Apr 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 14 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vitamin E | Experimental | Dietary Supplement: Vitamin E |
| Lipoic acid | Experimental | Dietary Supplement: Lipoic acid |
| Control | Placebo comparator | Dietary Supplement: Control |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin EDaily consumption of vitamin E capsules, 3 capsules of 268 mg daily, in total daily consumption of 804 mg | Dietary supplement | Vitamin E |
| Lipoic acidDaily consumption of lipoic acid capsules, 3 capsules of 200 mg daily, in total daily consumption of 600 mg | Dietary supplement | Lipoic acid |
| ControlDaily consumption of 3 placebo capsules | Dietary supplement | Control |
Primary outcome
Plasma oxyphytosterol concentrations
Time frame: Measured after 4 weeks intervention
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jogchum Plat, Prof. principal investigator
Maastricht University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin E and Lipoic acid in people with Oxidative Stress, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma oxyphytosterol concentrations (time frame: Measured after 4 weeks intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2013.