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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
History of Changes
  Purpose

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 Intervention
Oxidative Stress
Inflammation
 Dietary Supplement: nutraceutical group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Green Beat:

Primary Outcome Measures:
  • 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.


Enrollment: 44
Study Start Date: October 2011
Study Completion Date: December 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 50 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: November 16, 2011
Last Updated: April 9, 2013
Health Authority: Austria: Ethikkommission

Keywords provided by Green Beat:
Oxidative stress
inflammation
blood flow

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013