NCT03176212

Brief Summary

This study was designed to determine if an ingredient in milk fat can prevent gut leakiness induced by running at 80% maximum oxygen consumption (VO2max). In mouse studies, the milk fat ingredient, and individual components thereof, have been shown to reduce gut leakiness induced by intra peritoneal lipopolysaccharide (LPS) injections. The investigators hypothesis is as follows: Compared to a sports drink with identical macro nutrient composition, a sports drink with milk fat globule membrane (MFGM) will reduce the change in gut leakiness induced by running at 90% VO2max for 30 minutes. The decrease in gut permeability change will be associated with a decreased area under the curve of plasma endotoxin for 5 hours following the exercise. In addition, decreased gut permeability will be associated with lower area under the curve values for inflammatory cytokines.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

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

Study Start

First participant enrolled

January 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 5, 2017

Completed
Last Updated

June 5, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

May 10, 2017

Last Update Submit

May 31, 2017

Conditions

Inflammation

Keywords

Gut permeabilityCytokineEndotoxin

Outcome Measures

Primary Outcomes (1)

  • Change in gut permeability via differential sugar test

    In this outcome, the barrier properties of the gut are assessed indirectly. Subjects consume a mixture of lactulose and mannitol. Mannitol is a monosaccharide and is passively absorbed from the gut and eliminated via the urine. Lactulose, on the other hand, is an indigestible disaccharide. If it appears in the urine, it is thought to pass into the body through loose tight junctions between the mouth and large intestine. If it reaches the large intestine, lactulose will be fermented by the microbiome. Subjects consume the sugar mixture and urine is collected for 6 hours. In this study, gut permeability was measured at baseline, and after after the running tests.

    Gut permeability was measured three times in this study. Once at baseline, and twice after the exercise challenges. The total time to complete the assessment was approximately 3 weeks.

Secondary Outcomes (5)

  • Core temperature increase

    This outcome was measured twice in a time frame of less than three weeks.

  • Change in plasma lactate

    This outcome was measured twice in a time frame of less than three weeks.

  • Change in plasma cytokines

    This outcome was measured twice in a time frame of less than three weeks.

  • Change in plasma endotoxin

    This outcome was measured twice in a time frame of less than three weeks.

  • Change in plasma creatine kinase

    This outcome was measured twice in a time frame of less than three weeks.

Study Arms (2)

Beverage with milk fat globule membrane

ACTIVE COMPARATOR

In this arm, subjects consumed a beverage

Dietary Supplement: Milk fat globule membrane

Control

PLACEBO COMPARATOR

In this arm, subjects consumed a beverage with identical macronutrients

Dietary Supplement: Milk fat globule membrane

Interventions

Milk fat globule membraneDIETARY_SUPPLEMENT
Beverage with milk fat globule membraneControl

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ability to run at 80%V02max for 30m, availability to complete the study.

You may not qualify if:

  • Heart disease, uncontrolled hypertension, diabetes, Crohn's Disease, irritable bowel syndrome, colitis, celiac disease, inflammatory or autoimmune diseases, and lactose intolerance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Dial EJ, Zayat M, Lopez-Storey M, Tran D, Lichtenberger L. Oral phosphatidylcholine preserves the gastrointestinal mucosal barrier during LPS-induced inflammation. Shock. 2008 Dec;30(6):729-33. doi: 10.1097/SHK.0b013e318173e8d4.

    PMID: 18496240BACKGROUND

  • Pals KL, Chang RT, Ryan AJ, Gisolfi CV. Effect of running intensity on intestinal permeability. J Appl Physiol (1985). 1997 Feb;82(2):571-6. doi: 10.1152/jappl.1997.82.2.571.

    PMID: 9049739BACKGROUND

  • Davis MS, Willard MD, Williamson KK, Steiner JM, Williams DA. Sustained strenuous exercise increases intestinal permeability in racing Alaskan sled dogs. J Vet Intern Med. 2005 Jan-Feb;19(1):34-9. doi: 10.1892/0891-6640(2005)192.0.co;2.

    PMID: 15715045BACKGROUND

  • Lambert GP. Intestinal barrier dysfunction, endotoxemia, and gastrointestinal symptoms: the 'canary in the coal mine' during exercise-heat stress? Med Sport Sci. 2008;53:61-73. doi: 10.1159/000151550.

    PMID: 19208999BACKGROUND

  • Smetanka RD, Lambert GP, Murray R, Eddy D, Horn M, Gisolfi CV. Intestinal permeability in runners in the 1996 Chicago marathon. Int J Sport Nutr. 1999 Dec;9(4):426-33. doi: 10.1123/ijsn.9.4.426.

    PMID: 10660873BACKGROUND

  • Nieman DC, Henson DA, Dumke CL, Oley K, McAnulty SR, Davis JM, Murphy EA, Utter AC, Lind RH, McAnulty LS, Morrow JD. Ibuprofen use, endotoxemia, inflammation, and plasma cytokines during ultramarathon competition. Brain Behav Immun. 2006 Nov;20(6):578-84. doi: 10.1016/j.bbi.2006.02.001. Epub 2006 Mar 22.

    PMID: 16554145BACKGROUND

  • Lambert GP, Lang J, Bull A, Pfeifer PC, Eckerson J, Moore G, Lanspa S, O'Brien J. Fluid restriction during running increases GI permeability. Int J Sports Med. 2008 Mar;29(3):194-8. doi: 10.1055/s-2007-965163. Epub 2007 Jul 5.

    PMID: 17614027BACKGROUND

  • Ng QY, Lee KW, Byrne C, Ho TF, Lim CL. Plasma endotoxin and immune responses during a 21-km road race under a warm and humid environment. Ann Acad Med Singap. 2008 Apr;37(4):307-14.

    PMID: 18461215BACKGROUND

  • Pritchett K, Bishop P, Pritchett R, Green M, Katica C. Acute effects of chocolate milk and a commercial recovery beverage on postexercise recovery indices and endurance cycling performance. Appl Physiol Nutr Metab. 2009 Dec;34(6):1017-22. doi: 10.1139/H09-104.

    PMID: 20029509BACKGROUND

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 10, 2017

First Posted

June 5, 2017

Study Start

January 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

June 5, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share