Back to resultsStrong Women Study
Primary Purpose
Oxidative Stress, Inflammation
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
nutraceutical group
Sponsored by
About this trial
This is an interventional basic science trial for Oxidative Stress focused on measuring Oxidative stress, inflammation, blood flow
Eligibility 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
Sites / Locations
- Medical University of Graz
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
fruit, berry and vegetable concentrate
20 women with placebo
Arm Description
20 ladies receive an encapsulated, powdered fruit, berry and vegetable concentrate for 8 weeks
placebo for 8 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01476033
Brief Title
Strong Women Study
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Green Beat
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxidative Stress, Inflammation
Keywords
Oxidative stress, inflammation, blood flow
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fruit, berry and vegetable concentrate
Arm Type
Active Comparator
Arm Description
20 ladies receive an encapsulated, powdered fruit, berry and vegetable concentrate for 8 weeks
Arm Title
20 women with placebo
Arm Type
Placebo Comparator
Arm Description
placebo for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
nutraceutical group
Intervention Description
6 capsules of supplement or placebo for 8wk
Primary Outcome Measure Information:
Title
Carbonyl groups on protein, oxidized LDL, Malondialdehyde, TNF-alpha, IL-6, Trombelastometry and peripheral microcirculation
Description
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.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manfred Lamprecht, PhD PhD
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz
City
Graz
ZIP/Postal Code
8010
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
Strong Women Study
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