Strong Women Study

Inflammation Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01476033
• Other study ID #: 23-508 ex 10/11
• Status: Completed
• Phase: N/A
• First received: November 16, 2011
• Last updated: April 9, 2013
• Start date: October 2011
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: Green Beat
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical 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.

• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Inflammation
• Oxidative Stress

Intervention

Dietary Supplement:
• nutraceutical group
6 capsules of supplement or placebo for 8wk

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Green Beat

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No