Strong Women Study

NCT ID: NCT01476033

Last Updated: 2013-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oxidative Stress Inflammation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

fruit, berry and vegetable concentrate

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

Group Type ACTIVE_COMPARATOR

nutraceutical group

Intervention Type DIETARY_SUPPLEMENT

6 capsules of supplement or placebo for 8wk

20 women with placebo

placebo for 8 weeks

Group Type PLACEBO_COMPARATOR

nutraceutical group

Intervention Type DIETARY_SUPPLEMENT

6 capsules of supplement or placebo for 8wk

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

nutraceutical group

6 capsules of supplement or placebo for 8wk

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

35 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Green Beat

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lamprecht Manfred PhD, PhD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Manfred Lamprecht, PhD PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical University of Graz

Graz, , Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

23-508 ex 10/11

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Probiotic Sport Study
NCT01474629 COMPLETED NA