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OpenTrials
Completed

NCT Number: NCT01476033

Strong Women Study

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.

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Key information

Age range

35 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Graz

Graz, 8010, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nutraceutical group

Dietary Supplement

6 capsules of supplement or placebo for 8wk

Primary outcomes

  1. Carbonyl groups on protein, oxidized LDL, Malondialdehyde, TNF-alpha, IL-6, Trombelastometry and peripheral microcirculation

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Green Beat

Other

Registry information

Official study title

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.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 22, 2011
Registry last updated
Apr 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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