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

Tracking Information

First Received Date ^ICMJE

November 16, 2011

Last Updated Date

April 9, 2013

Start Date ^ICMJE

October 2011

Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01476033 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Strong Women Study

Official Title ^ICMJE

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.

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science

Condition ^ICMJE

Oxidative Stress
Inflammation

Intervention ^ICMJE

Dietary Supplement: nutraceutical group

6 capsules of supplement or placebo for 8wk

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2012

Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

35 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria

Administrative Information

NCT Number ^ICMJE

NCT01476033

Other Study ID Numbers ^ICMJE

23-508 ex 10/11

Has Data Monitoring Committee

Yes

Responsible Party

Lamprecht Manfred PhD, PhD, Green Beat

Study Sponsor ^ICMJE

Green Beat

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Manfred Lamprecht, PhD PhD

Medical University of Graz

Information Provided By

Green Beat

Verification Date

April 2013

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

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