Strong Women Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lamprecht Manfred PhD, PhD, Green Beat
ClinicalTrials.gov Identifier:
NCT01476033
First received: November 16, 2011
Last updated: April 9, 2013
Last verified: April 2013

November 16, 2011
April 9, 2013
October 2011
April 2012   (final data collection date for primary outcome measure)
Carbonyl groups on protein, oxidized LDL, Malondialdehyde, TNF-alpha, IL-6, Trombelastometry and peripheral microcirculation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01476033 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
Strong Women Study
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.

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
  • Oxidative Stress
  • Inflammation
Dietary Supplement: nutraceutical group
6 capsules of supplement or placebo for 8wk
  • Active Comparator: fruit, berry and vegetable concentrate
    20 ladies receive an encapsulated, powdered fruit, berry and vegetable concentrate for 8 weeks
    Intervention: Dietary Supplement: nutraceutical group
  • Placebo Comparator: 20 women with placebo
    placebo for 8 weeks
    Intervention: Dietary Supplement: nutraceutical group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
December 2012
April 2012   (final data collection date for primary outcome measure)

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
Female
35 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01476033
23-508 ex 10/11
Yes
Lamprecht Manfred PhD, PhD, Green Beat
Green Beat
Not Provided
Principal Investigator: Manfred Lamprecht, PhD PhD Medical University of Graz
Green Beat
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP