Blood Cell Response to Exercise

This study is currently recruiting participants.
Verified January 2014 by USDA Grand Forks Human Nutrition Research Center
Sponsor:
Information provided by (Responsible Party):
Matthew Picklo, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01872273
First received: May 1, 2013
Last updated: January 2, 2014
Last verified: January 2014

May 1, 2013
January 2, 2014
February 2013
December 2014   (final data collection date for primary outcome measure)
Platelet Reactivity [ Time Frame: Baseline, post-intervention (24 hours), & time points during the exercise phase: prior to exercise (-25 min, -10 min, - 1 min), 10 minutes into the routine, at completion (25 minutes), and 20 & 60 minutes following completion ]
We hypothesize that moderate physical exercise will increase platelet reactivity in sedentary individuals with metabolic syndrome. Platelet reactivity will be measured by flow cytometry using anti-CD61 antibodies as a marker for platelets and anti-CD62 (P-selectin) as a marker of platelet activation. This will be measured at baseline, post-intervention and time points post-baseline in each subject.
Same as current
Complete list of historical versions of study NCT01872273 on ClinicalTrials.gov Archive Site
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Blood Cell Response to Exercise
Blood Cell Response to Exercise

Moderate exercise is recommended to improve cardiovascular health in obese and overweight people particularly with metabolic syndrome (MetS) that have hypertension, elevated fasting blood sugar, and elevated blood lipids. This study is being done to determine how platelets respond when a person performs an initial period of moderate exercise.

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Interventional
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Intervention Model: Single Group Assignment
Metabolic Syndrome
Other: Moderate Physical Exercise
This intervention is comprised of two separate visits at least one week apart. The purpose of visit 1 is to determine the cycle ergometer workload that produces a moderate exercise intensity of 60% heart rate reserve to be used on visit 2. The purpose of visit 2 is to determine changes in platelet reactivity in response to moderate exercise.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
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December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 30-60 years old
  • BMI >/=26 and <40 kg/m2
  • not planning to or currently attempting to gain or lose weight
  • low reported omega-3 fatty acid intake per Omega-3 Checklist
  • Metabolic Syndrome as define 3/5 of the following:Waist circumference: men > 102 cm women > 88 cm, triglycerides > 150 mg/dL, HDL cholesterol: men < 40 mg/dL women < 50 mg/dL,Blood pressure >130/>85 mmHg,Fasting glucose > 100 mg/dL (Hypertensive subjects are eligible if taking thiazide diuretics NOT ACE inhibitors beta blockers)

Exclusion Criteria:

  • smoke or use tobacco or nicotine in any form (including pills and patches)
  • take any medication that makes you unable to exercise
  • have established cardiovascular, pulmonary, and/or metabolic disease such as diabetes
  • have uncontrolled hypertension
  • have alcohol, anabolic steroid, or other substance abuse issues
  • consume more than 3 alcoholic drinks/week
  • have joint or muscle injuries that affects your ability to exercise
  • have cancer (other than skin cancer or carcinoma in situ of the cervix
  • pregnant or lactating
  • currently exercise regularly
  • taking non-steroidal anti-inflammatory medications (aspirin, Aleve, Advil, ibuprofen, naproxen
  • take lipid modifying medications such as statins (Lipitor, Zocor)
  • take medications for blood glucose such as insulin or metformin
  • take medications that affect platelet functions (Plavix)
  • taking omega-3 supplements (fish or flax oil)
Both
30 Years to 60 Years
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Contact: Julie Dahlman, RN, BSN 701-795-8300 julie.dahlman@ars.usda.gov
United States
 
NCT01872273
GFHNRC026
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Matthew Picklo, USDA Grand Forks Human Nutrition Research Center
USDA Grand Forks Human Nutrition Research Center
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Principal Investigator: Matthew Picklo, PhD USDA Grand Forks Human Nutiriton Center
USDA Grand Forks Human Nutrition Research Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP