Clinical trial NCT02919488: The Effect of an Acute Bout of Exercise on High-sugar Meal Induced Endothelial Dysfunction
Official title: The Effect of an Acute Bout of Exercise on High-sugar Meal Induced Endothelial Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Dysfunction
Lead sponsor: Texas Christian University
Sponsor class: OTHER
First posted: 2016-09-29
Enrollment: 22
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in brachial artery flow mediated dilation
timeFrame: 0, 60, 120, and 180 minutes
Secondary outcomes:
measure: Change in blood nitric oxide concentration
timeFrame: 0, 60, 120, and 180 minutes
measure: Change in blood endothelin-1concentration
timeFrame: 0, 60, 120, and 180 minutes
measure: Change in blood angiotensin II concentration
timeFrame: 0, 60, 120, and 180 minutes
measure: Change in blood glucose concentration
timeFrame: 0, 60, 120, and 180 minutes
measure: Change in blood insulin concentration
timeFrame: 0, 60, 120, and 180 minutes
measure: Change in blood lipoprotein particle numbers
timeFrame: 0, 60, 120, and 180 minutes
measure: Change in blood lipid concentration
timeFrame: 0, 60, 120, and 180 minutes
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Texas Christian University
state: Texas
Study officials:
affiliation: Tzu Chi University
name: Meena Shah, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Widmer 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.
citation: Loader 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.
citation: Zhu 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.
citation: Weiss 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.
citation: Shah 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.
citation: Shah 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.