NCT02919488

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 27, 2018

Status Verified

April 1, 2018

Enrollment Period

1.1 years

First QC Date

September 27, 2016

Last Update Submit

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

EXPERIMENTAL
Other: Exercise Condition

Control Condition

ACTIVE COMPARATOR
Other: Control Condition

Interventions

A bout of exercise in the evening followed by high-sugar meal consumption the following morning

Exercise Condition

Rest in the evening followed by high-sugar meal consumption the following morning

Control Condition

Eligibility Criteria

Age45 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 15643116BACKGROUND
  • 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.

    PMID: 25780786BACKGROUND
  • 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.

    PMID: 26112007BACKGROUND
  • 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.

    PMID: 17206439BACKGROUND
  • 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.

    PMID: 18614723BACKGROUND
  • 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.

  • 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.

Study Officials

  • Meena Shah, Ph.D.

    Tzu Chi University

    PRINCIPAL INVESTIGATOR

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

Locations