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ClinicalTrials.gov Identifier: NCT01872273
Recruitment Status :
(Project never funded. No subjects were recruited.)
First Posted : June 7, 2013
Last Update Posted : July 1, 2016
USDA Grand Forks Human Nutrition Research Center
Information provided by (Responsible Party):
Matthew Picklo, USDA Grand Forks Human Nutrition Research Center
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.
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.
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.
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Ages Eligible for Study:
30 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Obese adults with Metabolic Syndrome
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)
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