The Effect of an Acute Bout of Exercise on High-sugar Meal Induced Endothelial Dysfunction
1 other identifier
interventional
22
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2016
CompletedFirst Posted
Study publicly available on registry
September 29, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedApril 27, 2018
April 1, 2018
1.1 years
September 27, 2016
April 25, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change in brachial artery flow mediated dilation
0, 60, 120, and 180 minutes
Secondary Outcomes (7)
Change in blood nitric oxide concentration
0, 60, 120, and 180 minutes
Change in blood endothelin-1concentration
0, 60, 120, and 180 minutes
Change in blood angiotensin II concentration
0, 60, 120, and 180 minutes
Change in blood glucose concentration
0, 60, 120, and 180 minutes
Change in blood insulin concentration
0, 60, 120, and 180 minutes
- +2 more secondary outcomes
Study Arms (2)
Exercise Condition
EXPERIMENTALControl Condition
ACTIVE COMPARATORInterventions
A bout of exercise in the evening followed by high-sugar meal consumption the following morning
Rest in the evening followed by high-sugar meal consumption the following morning
Eligibility Criteria
You may qualify if:
- Post-menopausal women
- Must be 45-70 years
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Texas Christian University
Fort Worth, Texas, 76129, United States
Related Publications (7)
Deanfield J, Donald A, Ferri C, Giannattasio C, Halcox J, Halligan S, Lerman A, Mancia G, Oliver JJ, Pessina AC, Rizzoni D, Rossi GP, Salvetti A, Schiffrin EL, Taddei S, Webb DJ; Working Group on Endothelin and Endothelial Factors of the European Society of Hypertension. Endothelial function and dysfunction. Part I: Methodological issues for assessment in the different vascular beds: a statement by the Working Group on Endothelin and Endothelial Factors of the European Society of Hypertension. J Hypertens. 2005 Jan;23(1):7-17. doi: 10.1097/00004872-200501000-00004.
PMID: 15643116BACKGROUNDWidmer RJ, Lerman A. Endothelial dysfunction and cardiovascular disease. Glob Cardiol Sci Pract. 2014 Oct 16;2014(3):291-308. doi: 10.5339/gcsp.2014.43. eCollection 2014. No abstract available.
PMID: 25780786BACKGROUNDLoader J, Montero D, Lorenzen C, Watts R, Meziat C, Reboul C, Stewart S, Walther G. Acute Hyperglycemia Impairs Vascular Function in Healthy and Cardiometabolic Diseased Subjects: Systematic Review and Meta-Analysis. Arterioscler Thromb Vasc Biol. 2015 Sep;35(9):2060-72. doi: 10.1161/ATVBAHA.115.305530. Epub 2015 Jun 25.
PMID: 26112007BACKGROUNDZhu W, Zhong C, Yu Y, Li K. Acute effects of hyperglycaemia with and without exercise on endothelial function in healthy young men. Eur J Appl Physiol. 2007 Apr;99(6):585-91. doi: 10.1007/s00421-006-0378-3. Epub 2007 Jan 6.
PMID: 17206439BACKGROUNDWeiss EP, Arif H, Villareal DT, Marzetti E, Holloszy JO. Endothelial function after high-sugar-food ingestion improves with endurance exercise performed on the previous day. Am J Clin Nutr. 2008 Jul;88(1):51-7. doi: 10.1093/ajcn/88.1.51.
PMID: 18614723BACKGROUNDShah M, Gloeckner A, Bailey S, Adams-Huet B, Kreutzer A, Cheek D, Willis JL, Mitchell J. Effect of a late afternoon/early evening bout of aerobic exercise on postprandial lipid and lipoprotein particle responses to a high-sugar meal breakfast the following day in postmenopausal women: a randomized cross-over study. J Sports Sci. 2022 Jan;40(2):175-184. doi: 10.1080/02640414.2021.1982497. Epub 2021 Sep 27.
PMID: 34565292DERIVEDShah M, Bailey S, Gloeckner A, Kreutzer A, Adams-Huet B, Cheek D, Mitchell J. Effect of acute exercise on postprandial endothelial function in postmenopausal women: a randomized cross-over study. J Investig Med. 2019 Aug;67(6):964-970. doi: 10.1136/jim-2019-000992. Epub 2019 Mar 5.
PMID: 30842213DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Meena Shah, Ph.D.
Tzu Chi University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 27, 2016
First Posted
September 29, 2016
Study Start
November 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
April 27, 2018
Record last verified: 2018-04