Oxidative StressNCT01476033
Strong Women Study
A study testing nutraceutical group in people with Oxidative Stress and Inflammation, run by Green Beat at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Inflammation
- What is being tested?
- nutraceutical group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women
- BMI > 27
- praemenopausal
- non smokers
- eligibility for exercise
- 4wk wash out
Who cannot join
- male
- all people not matching this age group
- BMI > 40 and < 27
- peri- or postmenopausal women
- smokers
- all women taking dietary supplements
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
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
- Being tested
- nutraceutical group
- Keywords
- Oxidative stress, inflammation, blood flow
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutraceutical groupDietary supplement
6 capsules of supplement or placebo for 8wk
| Study group | Role | What they receive |
|---|---|---|
| fruit, berry and vegetable concentrate | Active comparator | 20 ladies receive an encapsulated, powdered fruit, berry and vegetable concentrate for 8 weeks Receives: Dietary Supplement: nutraceutical group |
| 20 women with placebo | Placebo comparator | placebo for 8 weeks Receives: Dietary Supplement: nutraceutical group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Beat
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamprecht Manfred PhD, PhD, Green Beat
- Investigators
- Manfred Lamprecht, PhD PhD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476033
- Sponsor's protocol ID
- 23-508 ex 10/11
- Status last verified
- Apr 2013
- First submitted
- 16 Nov 2011
- Last updated
- 10 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01476033
- Acronym / sponsor ID
- 23-508 ex 10/11
- Conditions
- Oxidative Stress, Inflammation
- Keywords
- Oxidative stress, inflammation, blood flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Green BeatUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fruit, berry and vegetable concentrate | Active comparator | Dietary Supplement: nutraceutical group20 ladies receive an encapsulated, powdered fruit, berry and vegetable concentrate for 8 weeks |
| 20 women with placebo | Placebo comparator | Dietary Supplement: nutraceutical groupplacebo for 8 weeks |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- women
- BMI > 27
- praemenopausal
- non smokers
- eligibility for exercise
Key exclusion criteria (9 listed)
- male
- all people not matching this age group
- BMI > 40 and < 27
- peri- or postmenopausal women
- smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutraceutical group6 capsules of supplement or placebo for 8wk | Dietary supplement | 20 women with placebo, fruit, berry and vegetable concentrate |
Primary outcome
Carbonyl groups on protein, oxidized LDL, Malondialdehyde, TNF-alpha, IL-6, Trombelastometry and peripheral microcirculation
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manfred Lamprecht, PhD PhD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutraceutical group in people with Oxidative Stress and Inflammation, run by Green Beat at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carbonyl groups on protein, oxidized LDL, Malondialdehyde, TNF-alpha, IL-6, Trombelastometry and peripheral microcirculation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2013.