Strong Women Study

April 9, 2013 updated by: Lamprecht Manfred PhD, PhD, Green Beat

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8010
        • Medical University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Green Beat

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

November 16, 2011

First Submitted That Met QC Criteria

November 17, 2011

First Posted (ESTIMATE)

November 22, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 10, 2013

Last Update Submitted That Met QC Criteria

April 9, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-508 ex 10/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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