Metabolic SyndromeNCT01316081
A 4-month Intervention of Antioxidant Supplementation in Overweight Children
A study testing Vitamin C Vitamin E Selenvital all from Burgerstein Vitamine in people with Metabolic Syndrome, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
In obese children, low antioxidant vitamin intake and reduced antioxidant capacity are common. Weight reduction reduces subclinical inflammation in obese subjects, and, similarly, antioxidant vitamins have been shown to reduce the expression of proinflammatory cytokines. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Vitamin C Vitamin E Selenvital all from Burgerstein Vitamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2011to Jun 2012
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age between 10 to 18 years old
- BMI over the 85th percentile for age and sex
Who cannot join
- history of nephrolithiasis
- history of bleeding disorder
- smoking
- type 2 diabetes
- NAFLD
- Asthma
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Federal Institute of Technology , Laboratory of Human Nutrition
Zurich, 8092
About this study
Official title: A 4-month, Randomized, Placebo-controlled, Double-blind Intervention of Antioxidant Supplementation in Overweight Children Enrolled in an Outpatient Weight-loss Program: Effects on Oxidative and Inflammatory Markers, Hepcidin, Iron Status, and Components of the Metabolic Syndrome
In obese children, low antioxidant vitamin intake and reduced antioxidant capacity are common. Weight reduction reduces subclinical inflammation in obese subjects, and, similarly, antioxidant vitamins have been shown to reduce the expression of proinflammatory cytokines. Moreover, antioxidants reduce oxidative stress which influences endothelial function and might play a crucial role in the pathogenesis of obesity-related disorders. Furthermore, overweight children and adults have a markedly increased risk for iron deficiency. The mechanism linking obesity with iron deficiency is unclear. Growing evidence suggests that the elevated inflammatory status associated with obesity increases circulating hepcidin and this contributes to iron deficiency. Weight reduction has been shown to be associated with reduced inflammation and serum hepcidin concentrations, and an improved functional iron state. Thus, reducing inflammation in obese children may improve iron metabolism and reduce their risk of iron deficiency.
Therefore, positive effects on subclinical inflammation, hepcidin/iron status and metabolic risk factors in obese children during weight loss may be enhanced by supplementation with antioxidants.
Read more
The aim of the present study is to investigate the effect of 4-month antioxidant supplementation on subclinical inflammation, hepcidin, iron status and components of the metabolic syndrome in overweight children undergoing an outpatient weight-loss program.
Our hypotheses are: 1. During an outpatient weight loss program, antioxidant supplementation will reduce oxidative and inflammatory stress associated with obesity to a greater extent than weight loss alone. 2. This will have two effects, compared to weight loss alone: a.It will reduce circulating hepcidin concentrations, and improve iron status. b.It will improve metabolic and cardiovascular risk factors.
Subjects The investigators plan to enroll 50 children who are participants in outpatient weight-loss programs in the German part of Switzerland. Enrollment will be done with the agreement and assistance of the physician supervising the weight-loss program, and the timing of the study measurements will be incorporated within the existing program schedule. It is anticipated that the baseline blood sample for this study will be obtained from the regular baseline venipuncture for the weight-loss study. Criteria for participation include age between 10 to 18 years and a BMI over the 85th percentile for age and sex. Exclusion criteria include major medical illnesses, including gastrointestinal, inflammatory, bleeding and/or endocrine disorders, a history of nephrolithiasis, unusual dietary habits (e.g. vegetarianism), major food allergies or intolerances (lactose, gluten), smoking, and use of chronic medications or vitamin/mineral antioxidant supplements.
Study design The study will be a double-blind, randomized, placebo-controlled intervention trial. Children will be randomly assigned to one of two groups: antioxidant (AO) or placebo (P) supplement. If it is necessary to enroll children from different weight-loss programs, then randomization will be stratified by program. During the 4-month weight loss period, the AO group will consume oral supplements of ascorbic acid (500mg), alpha tocopherol (400 IU), and 50 µg selenium (all from Burgerstein Vitamins, Rapperswil-Jona, Switzerland) each evening with diner, whereas the P group will consume identical-appearing placebo supplements.
- Conditions
- Metabolic Syndrome
- Being tested
- Vitamin C Vitamin E Selenvital all from Burgerstein Vitamine
- Keywords
- antioxidant supplementation, childhood obesity, hepcidin, iron status, oxidative stress, inflammation
- Medical subject headings
- Metabolic Syndrome, Pediatric Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin C Vitamin E Selenvital all from Burgerstein VitamineDietary supplement
Also called Burgerstein Vitamin C retard 500mg SWISSMEDIC Nr. 44259028, Burgerstein Vitamin E 400 I.E. SWISSMEDIC Nr. 44562014, Burgerstein Selenvital 50µg
Vitamin C: 500mg Vitamin E: 400 I.U. Selenium: 50mcg
Placebo Supplements: identical appearing tablets
| Study group | Role | What they receive |
|---|---|---|
| Antioxidant Group | Experimental | 500mg Vitamin C 400 I.E. Vitamin E 50 mcg Selenium Receives: Dietary Supplement: Vitamin C Vitamin E Selenvital all from Burgerstein Vitamine |
| Placebo Group | Placebo comparator | identical appearing placebo supplements Receives: Dietary Supplement: Vitamin C Vitamin E Selenvital all from Burgerstein Vitamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxidative markers (isoprostanes)
Measured: blood sample after 4 months
inflammatory parameters
Measured: blood sample after 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
- Investigators
- Michael B Zimmermann, Prof, Principal investigator, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316081
- Sponsor's protocol ID
- Aox_obesity_SM
- Status last verified
- Jun 2012
- First submitted
- 15 Mar 2011
- Last updated
- 19 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Murer SB, Aeberli I, Braegger CP, Gittermann M, Hersberger M, Leonard SW, Taylor AW, Traber MG, Zimmermann MB. Antioxidant supplements reduced oxidative stress and stabilized liver function tests but did not reduce inflammation in a randomized controlled trial in obese children and adolescents. J Nutr. 2014 Feb;144(2):193-201. doi: 10.3945/jn.113.185561. Epub 2013 Dec 18.
PubMed 24353344
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-month, Randomized, Placebo-controlled, Double-blind Intervention of Antioxidant Supplementation in Overweight Children Enrolled in an Outpatient Weight-loss Program: Effects on Oxidative and Inflammatory Markers, Hepcidin, Iron Status, and Components of the Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01316081
- Acronym / sponsor ID
- Aox_obesity_SM
- Conditions
- Metabolic Syndrome
- Keywords
- antioxidant supplementation, childhood obesity, hepcidin, iron status, oxidative stress, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 16 Mar 2011 (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.
In obese children, low antioxidant vitamin intake and reduced antioxidant capacity are common. Weight reduction reduces subclinical inflammation in obese subjects, and, similarly, antioxidant vitamins have been shown to reduce the expression of proinflammatory cytokines. Moreover, antioxidants reduce oxidative stress which influences endothelial function and might play a crucial role in the pathogenesis of obesity-related disorders. Furthermore, overweight children and adults have a markedly increased risk for iron deficiency. The mechanism linking obesity with iron deficiency is unclear. Growing evidence suggests that the elevated inflammatory status associated with obesity increases circulating hepcidin and this contributes to iron deficiency. Weight reduction has been shown to be associated with reduced inflammation and serum hepcidin concentrations, and an improved functional iron state. Thus, reducing inflammation in obese children may improve iron metabolism and reduce their risk of iron deficiency.
Therefore, positive effects on subclinical inflammation, hepcidin/iron status and metabolic risk factors in obese children during weight loss may be enhanced by supplementation with antioxidants.
The aim of the present study is to investigate the effect of 4-month antioxidant supplementation on subclinical inflammation, hepcidin, iron status and components of the metabolic syndrome in overweight children undergoing an outpatient weight-loss program.
Our hypotheses are: 1. During an outpatient weight loss program, antioxidant supplementation will reduce oxidative and inflammatory stress associated with obesity to a greater extent than weight loss alone. 2. This will have two effects, compared to weight loss alone: a.It will reduce circulating hepcidin concentrations, and improve iron status. b.It will improve metabolic and cardiovascular risk factors.
Subjects The investigators plan to enroll 50 children who are participants in outpatient weight-loss programs in the German part of Switzerland. Enrollment will be done with the agreement and assistance of the physician supervising the weight-loss program, and the timing of the study measurements will be incorporated within the existing program schedule. It is anticipated that the baseline blood sample for this study will be obtained from the regular baseline venipuncture for the weight-loss study. Criteria for participation include age between 10 to 18 years and a BMI over the 85th percentile for age and sex. Exclusion criteria include major medical illnesses, including gastrointestinal, inflammatory, bleeding and/or endocrine disorders, a history of nephrolithiasis, unusual dietary habits (e.g. vegetarianism), major food allergies or intolerances (lactose, gluten), smoking, and use of chronic medications or vitamin/mineral antioxidant supplements.
Study design The study will be a double-blind, randomized, placebo-controlled intervention trial. Children will be randomly assigned to one of two groups: antioxidant (AO) or placebo (P) supplement. If it is necessary to enroll children from different weight-loss programs, then randomization will be stratified by program. During the 4-month weight loss period, the AO group will consume oral supplements of ascorbic acid (500mg), alpha tocopherol (400 IU), and 50 µg selenium (all from Burgerstein Vitamins, Rapperswil-Jona, Switzerland) each evening with diner, whereas the P group will consume identical-appearing placebo supplements.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antioxidant Group | Experimental | Dietary Supplement: Vitamin C Vitamin E Selenvital all from Burgerstein Vitamine500mg Vitamin C 400 I.E. Vitamin E 50 mcg Selenium |
| Placebo Group | Placebo comparator | Dietary Supplement: Vitamin C Vitamin E Selenvital all from Burgerstein Vitamineidentical appearing placebo supplements |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- age between 10 to 18 years old
- BMI over the 85th percentile for age and sex
Key exclusion criteria (6 listed)
- history of nephrolithiasis
- history of bleeding disorder
- smoking
- type 2 diabetes
- NAFLD
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 C Vitamin E Selenvital all from Burgerstein VitamineAlso: Burgerstein Vitamin C retard 500mg SWISSMEDIC Nr. 44259028, Burgerstein Vitamin E 400 I.E. SWISSMEDIC Nr. 44562014, Burgerstein Selenvital 50µgVitamin C: 500mg Vitamin E: 400 I.U. Selenium: 50mcg Placebo Supplements: identical appearing tablets | Dietary supplement | Antioxidant Group, Placebo Group |
Primary outcome
oxidative markers (isoprostanes)
Time frame: blood sample after 4 months
inflammatory parameters
Time frame: blood sample after 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2012.
- Derived from this study: PubMed 24353344Murer SB, Aeberli I, Braegger CP, Gittermann M, Hersberger M, Leonard SW, Taylor AW, Traber MG, Zimmermann MB. Antioxidant supplements reduced oxidative stress and stabilized liver function tests but did not reduce inflammation in a randomized controlled trial in obese children and adolescents. J Nutr. 2014 Feb;144(2):193-201. doi: 10.3945/jn.113.185561. Epub 2013 Dec 18.
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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.
Michael B Zimmermann, Prof principal investigator
ETH Zurich
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 C Vitamin E Selenvital all from Burgerstein Vitamine in people with Metabolic Syndrome, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 19 Jun 2012. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
oxidative markers (isoprostanes) (time frame: blood sample after 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01316081, which also lists 1 linked publication.
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 19 Jun 2012.