Strong Women Study

Sponsor

Green Beat (Other)

Overall Status

Completed

CT.gov ID

NCT01476033

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Oxidative Stress Inflammation	Dietary Supplement: nutraceutical group	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

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 Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Graz	Graz		Austria	8010

Sponsors and Collaborators

Green Beat

Investigators

Principal Investigator: Manfred Lamprecht, PhD PhD, Medical University of Graz

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lamprecht Manfred PhD, PhD, Principal investigator, Green Beat

ClinicalTrials.gov Identifier:

NCT01476033

Other Study ID Numbers:

23-508 ex 10/11

First Posted:

Nov 22, 2011

Last Update Posted:

Apr 10, 2013

Last Verified:

Apr 1, 2013

Keywords provided by Lamprecht Manfred PhD, PhD, Principal investigator, Green Beat

Oxidative stress

inflammation

blood flow

Additional relevant MeSH terms:

Inflammation

Study Results

No Results Posted as of Apr 10, 2013