Strong Women Study

NCT01476033 | Completed DMC

• 1 other identifier: 23-508 ex 10/11
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxidative Stress; Inflammation

Keywords

Oxidative stress; inflammation; blood flow

Outcome Measures

Primary Outcomes (1)

• Carbonyl groups on protein, oxidized LDL, Malondialdehyde, TNF-alpha, IL-6, Trombelastometry and peripheral microcirculation

  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

Study Arms (2)

fruit, berry and vegetable concentrate

ACTIVE COMPARATOR

20 ladies receive an encapsulated, powdered fruit, berry and vegetable concentrate for 8 weeks

Dietary Supplement: nutraceutical group

20 women with placebo

PLACEBO COMPARATOR

placebo for 8 weeks

Dietary Supplement: nutraceutical group

Interventions

nutraceutical group DIETARY_SUPPLEMENT

6 capsules of supplement or placebo for 8wk

20 women with placebo; fruit, berry and vegetable concentrate

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women
• BMI \> 27
• praemenopausal
• non smokers
• eligibility for exercise
• wk wash out

You may not qualify if:

• 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

Sponsors & Collaborators

• Green Beat: lead

Study Sites (1)

Medical University of Graz

Graz, 8010, Austria

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Manfred Lamprecht, PhD PhD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 16, 2011
• First Posted: November 22, 2011
• Study Start: October 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 10, 2013

Record last verified: 2013-04

Locations

AU (1)