A 4-month Intervention of Antioxidant Supplementation in Overweight Children
Condition: Metabolic Syndrome
MeSH terms: Overweight; Metabolic Syndrome; Syndrome
Study type: Interventional

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.
      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.
    


Intervention name(s): Vitamin C Vitamin E Selenvital all from Burgerstein Vitamine
Intervention type(s): Dietary Supplement
Intervention description(s): Vitamin C: 500mg Vitamin E: 400 I.U. Selenium: 50mcg
Placebo Supplements: identical appearing tablets
Other intervention name(s): Burgerstein Vitamin C retard 500mg SWISSMEDIC Nr. 44259028; Burgerstein Vitamin E 400 I.E. SWISSMEDIC Nr. 44562014; Burgerstein Selenvital 50µg
Intervention MeSH terms: Vitamins; Ascorbic Acid; Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: antioxidant supplementation; childhood obesity; hepcidin; iron status; oxidative stress; inflammation