A 4-month Intervention of Antioxidant Supplementation in Overweight Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT01316081
First received: March 15, 2011
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Dietary Supplement: Vitamin C Vitamin E Selenvital all from Burgerstein Vitamine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Swiss Federal Institute of Technology:

Primary Outcome Measures:
  • oxidative markers (isoprostanes) [ Time Frame: blood sample after 4 months ] [ Designated as safety issue: No ]
  • inflammatory parameters [ Time Frame: blood sample after 4 months ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: March 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antioxidant Group
500mg Vitamin C 400 I.E. Vitamin E 50 mcg Selenium
Dietary Supplement: Vitamin C Vitamin E Selenvital all from Burgerstein Vitamine

Vitamin C: 500mg Vitamin E: 400 I.U. Selenium: 50mcg

Placebo Supplements: identical appearing tablets

Other Names:
  • Burgerstein Vitamin C retard 500mg SWISSMEDIC Nr. 44259028
  • Burgerstein Vitamin E 400 I.E. SWISSMEDIC Nr. 44562014
  • Burgerstein Selenvital 50µg
Placebo Comparator: Placebo Group
identical appearing placebo supplements
Dietary Supplement: Vitamin C Vitamin E Selenvital all from Burgerstein Vitamine

Vitamin C: 500mg Vitamin E: 400 I.U. Selenium: 50mcg

Placebo Supplements: identical appearing tablets

Other Names:
  • Burgerstein Vitamin C retard 500mg SWISSMEDIC Nr. 44259028
  • Burgerstein Vitamin E 400 I.E. SWISSMEDIC Nr. 44562014
  • Burgerstein Selenvital 50µg

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 10 to 18 years old
  • BMI over the 85th percentile for age and sex

Exclusion Criteria:

  • history of nephrolithiasis
  • history of bleeding disorder
  • smoking
  • type 2 diabetes
  • NAFLD
  • Asthma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316081

Locations
Switzerland
Swiss Federal Institute of Technology , Laboratory of Human Nutrition
Zürich, Switzerland, 8092
Sponsors and Collaborators
Swiss Federal Institute of Technology
Investigators
Principal Investigator: Michael B Zimmermann, Prof ETH Zurich
  More Information

No publications provided by Swiss Federal Institute of Technology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Michael B. Zimmermann, The Principal Investigator, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT01316081     History of Changes
Other Study ID Numbers: Aox_obesity_SM
Study First Received: March 15, 2011
Last Updated: June 18, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by Swiss Federal Institute of Technology:
antioxidant supplementation
childhood obesity
hepcidin
iron status
oxidative stress
inflammation

Additional relevant MeSH terms:
Overweight
Metabolic Syndrome X
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Antioxidants
Ascorbic Acid
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 23, 2014