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Strong Women Study

G

Green Beat

Status

Completed

Conditions

Inflammation
Oxidative Stress

Treatments

Dietary Supplement: nutraceutical group

Study type

Interventional

Funder types

Other

Identifiers

NCT01476033
23-508 ex 10/11

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

Female

Ages

35 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

44 participants in 2 patient groups, including a placebo group

fruit, berry and vegetable concentrate
Active Comparator group
Description:
20 ladies receive an encapsulated, powdered fruit, berry and vegetable concentrate for 8 weeks
Treatment:
Dietary Supplement: nutraceutical group
20 women with placebo
Placebo Comparator group
Description:
placebo for 8 weeks
Treatment:
Dietary Supplement: nutraceutical group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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