Strong Women Study

Not Applicable

Completed

• Conditions: Oxidative Stress; Inflammation
• Interventions: Dietary Supplement: nutraceutical group

• Registration Number: NCT01476033
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-11-16
• Study First Submitted QC: 2011-11-17
• Study First Posted: 2011-11-22
• Primary Completion: 2012-04
• Study Completion: 2012-12
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-09
• Last Update Posted: 2013-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fruit, berry and vegetable concentrate	nutraceutical group	20 ladies receive an encapsulated, powdered fruit, berry and vegetable concentrate for 8 weeks
20 women with placebo	nutraceutical group	placebo for 8 weeks

Primary Outcome Measures

Name	Time	Method
Carbonyl groups on protein, oxidized LDL, Malondialdehyde, TNF-alpha, IL-6, Trombelastometry and peripheral microcirculation	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.

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria