Blood Cell Response to Exercise

Sponsor

USDA Grand Forks Human Nutrition Research Center (U.S. Fed)

Overall Status

Withdrawn

CT.gov ID

NCT01872273

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Other: Moderate Physical Exercise

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Blood Cell Response to Exercise

Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Outcome Measures

Primary Outcome Measures

Platelet Reactivity [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)