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Strong Women Study

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ClinicalTrials.gov Identifier: NCT01476033
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : April 10, 2013
Sponsor:
Information provided by (Responsible Party):
Lamprecht Manfred PhD, PhD, Green Beat

Brief Summary:

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.

Condition or disease Intervention/treatment
Oxidative Stress Inflammation Dietary Supplement: nutraceutical group

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official 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.
Study Start Date : October 2011
Primary Completion Date : April 2012
Study Completion Date : December 2012

Arm Intervention/treatment
Active Comparator: fruit, berry and vegetable concentrate
20 ladies receive an encapsulated, powdered fruit, berry and vegetable concentrate for 8 weeks
Dietary Supplement: nutraceutical group
6 capsules of supplement or placebo for 8wk
Placebo Comparator: 20 women with placebo
placebo for 8 weeks
Dietary Supplement: nutraceutical group
6 capsules of supplement or placebo for 8wk



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01476033


Locations
Austria
Medical University of Graz
Graz, Austria, 8010
Sponsors and Collaborators
Green Beat
Investigators
Principal Investigator: Manfred Lamprecht, PhD PhD Medical University of Graz

Responsible Party: Lamprecht Manfred PhD, PhD, Principal investigator, Green Beat
ClinicalTrials.gov Identifier: NCT01476033     History of Changes
Other Study ID Numbers: 23-508 ex 10/11
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: April 10, 2013
Last Verified: April 2013

Keywords provided by Lamprecht Manfred PhD, PhD, Green Beat:
Oxidative stress
inflammation
blood flow

Additional relevant MeSH terms:
Inflammation
Pathologic Processes