The Effect of an Acute Bout of Exercise on High-sugar Meal Induced Endothelial Dysfunction

April 25, 2018 updated by: Meena Shah, Texas Christian University
The purpose of this study is to determine if postprandial (after a meal) endothelial (inner lining of blood vessels) dysfunction induced by a high sugar meal improves with a bout of exercise

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Endothelial dysfunction is due to an imbalance between vasodilating and vasoconstricting substances produced by the endothelium. An imbalance in these substances limits the ability of the blood vessel to relax in response to a shear stress stimulus. Endothelial dysfunction is a major risk factor for cardiovascular disease.

High-sugar intakes result in postprandial hyperglycemia and endothelial dysfunction. Exercise may attenuate the endothelial dysfunction induced by a high-sugar meal. There are only two studies that have examined the effect of exercise on endothelial dysfunction induced by high-sugar intake. Both studies found that a bout of aerobic exercise attenuated the impaired flow mediated dilation induced by high-sugar ingestion. Neither study measured important markers of endothelial dysfunction such as blood nitric oxide, endothelin I, and angiotensin II concentrations, however. In addition, whether the same results apply to older post-menopausal women is unknown. Understanding how acute exercise affects meal-induced endothelial dysfunction in older women is important given that age is related to endothelial dysfunction and cardiovascular disease.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76129
        • Texas Christian University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Post-menopausal women
  • Must be 45-70 years

Exclusion Criteria:

  • Use of medications or supplements to lose weight
  • Following a weight loss diet
  • Smoking
  • Heavy alcohol consumption
  • Diabetes
  • Heart disease
  • Stroke
  • Liver disease
  • Kidney disease
  • Untreated thyroid disease
  • Anemia
  • Uncontrolled hypertension
  • Pulmonary disease that prevents exercise
  • Orthopedic problems that prevents exercise
  • Arthritis problems that prevent exercise
  • Musculoskeletal problems that prevent exercise.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Condition
Other: Control Condition
Rest in the evening followed by high-sugar meal consumption the following morning
Experimental: Exercise Condition
Other: Exercise Condition
A bout of exercise in the evening followed by high-sugar meal consumption the following morning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in brachial artery flow mediated dilation
Time Frame: 0, 60, 120, and 180 minutes
0, 60, 120, and 180 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in blood nitric oxide concentration
Time Frame: 0, 60, 120, and 180 minutes
0, 60, 120, and 180 minutes
Change in blood endothelin-1concentration
Time Frame: 0, 60, 120, and 180 minutes
0, 60, 120, and 180 minutes
Change in blood angiotensin II concentration
Time Frame: 0, 60, 120, and 180 minutes
0, 60, 120, and 180 minutes
Change in blood glucose concentration
Time Frame: 0, 60, 120, and 180 minutes
0, 60, 120, and 180 minutes
Change in blood insulin concentration
Time Frame: 0, 60, 120, and 180 minutes
0, 60, 120, and 180 minutes
Change in blood lipoprotein particle numbers
Time Frame: 0, 60, 120, and 180 minutes
0, 60, 120, and 180 minutes
Change in blood lipid concentration
Time Frame: 0, 60, 120, and 180 minutes
0, 60, 120, and 180 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Christian University

Investigators

  • Principal Investigator: Meena Shah, Ph.D., Tzu Chi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

September 27, 2016

First Submitted That Met QC Criteria

September 28, 2016

First Posted (Estimate)

September 29, 2016

Study Record Updates

Last Update Posted (Actual)

April 27, 2018

Last Update Submitted That Met QC Criteria

April 25, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • CT2016MS2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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