Strong Women Study

Study Overview
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Brief Summary
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The investigators investigate the impact of an encapsulated fruit, berry and vegetable juice powder concentrate on oxidative stress, inflammation and blood flow before and post exercise in overweight, middle-aged, women. Main hypotheses (H1): The nutraceutical has an impact on oxidative stress reduction. The nutraceutical has an impact on inflammation. The nutraceutical has an impact on blood flow and microcirculation. Walking exercise for 30 minutes has an impact on oxidative stress- and inflammation markers. Walking exercise for 30 minutes has an impact on blood flow and microcirculation The combination of nutraceutical supplementation + walking exercise for 30 minutes has an impact on oxidative stress- and inflammation markers, and on blood flow/microcirculation.

Official Title
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Impact of Encapsulated Fruit, Berry and Vegetable Juice Powder Concentrate on Oxidative Stress, Inflammation and Blood Flow Before and Post Exercise in Overweight, Middle-aged, Women.

Conditions
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Oxidative Stress, Inflammation

Intervention / Treatment
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* Dietary Supplement: nutraceutical group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women BMI > 27 praemenopausal non smokers eligibility for exercise 4wk wash out Exclusion Criteria: male all people not matching this age group BMI > 40 and < 27 peri- or postmenopausal women smokers all women taking dietary supplements all women that fail in ergometric exercise eligibility testing, refering to the standards in sports medicine (e.g.: significant ST-decrease or increase, blood pressure > 240 mmHg, tachycardia, polymorphic extrasystolia, cyanosis, bradyarrhythmia..) Diabetics osteoporosis or osteopenia

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fruit, berry and vegetable concentrate<br>20 ladies receive an encapsulated, powdered fruit, berry and vegetable concentrate for 8 weeks | Dietary Supplement: nutraceutical group<br>* 6 capsules of supplement or placebo for 8wk<br>|
| Placebo Comparator: 20 women with placebo<br>placebo for 8 weeks | Dietary Supplement: nutraceutical group<br>* 6 capsules of supplement or placebo for 8wk<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carbonyl groups on protein, oxidized LDL, Malondialdehyde, TNF-alpha, IL-6, Trombelastometry and peripheral microcirculation | Carbonyl groups on protein as indicators of protein oxidation; oxidized LDL, Malondialdehyde as indicators of Lipidoxidation; TNF-alpha, IL-6 as indicators of inflammation; Trombelastometry: clotting time, thrombocyte ahesion, trombocyte aggregation from whole blood as indicators for blood flow and hemostasis; Peripheral microcirculation in subcutis as indicator for blood flow in peripheral subcutis. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxidative stress, inflammation, blood flow