Blood Cell Response to Exercise

NCT ID: NCT01872273

Last Updated: 2022-02-02

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2016-06-30

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.

Conditions

Metabolic Syndrome

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

USDA Grand Forks Human Nutrition Research Center

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Picklo, PhD

Role: PRINCIPAL_INVESTIGATOR

USDA Grand Forks Human Nutrition Research Center

Other Identifiers

GFHNRC026

Identifier Type: -

Identifier Source: org_study_id