NCT03425578

Brief Summary

Amino acids play an important role in human metabolism. In aging individuals and in some diseases, certain amino acids, such as glutamate, are at lower than normal levels. Glutamate appears to be involved in providing energy and maintaining normal blood sugar (glucose) levels, processes which both depend heavily on skeletal muscle. The maintenance of healthy blood sugar levels, in particular, is tightly related to overall muscle mass and quality. To better understand the link between glutamate and glucose metabolism in skeletal muscle, the investigators will be using a nutritional approach to raise the body's glutamate levels with monosodium glutamate (MSG) supplementation, and raise blood glucose levels with a sugary drink. By altering the normal levels of glutamate and glucose in the blood and muscle tissue, the investigators can gather more information about the role of glutamate in energy metabolism. This will help the design of future studies investigating the function of glutamate in aging and disease. During this study the investigators will increase the levels of glutamate and glucose in the bloodstream by asking participants to ingest MSG along with a sugary drink. The goal is to subsequently determine: A) the amount of glutamate and glucose that ends up in the muscle; and B) whether normal skeletal muscle glucose metabolism, and the behaviour of additional amino acids (other than glutamate) is altered. The hypothesis is that when MSG and sugar drink are ingested together glucose uptake and metabolism within the skeletal muscle will be elevated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Mar 2018

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

January 17, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

March 19, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2018

Completed
Last Updated

June 12, 2019

Status Verified

June 1, 2019

Enrollment Period

7 months

First QC Date

January 17, 2018

Last Update Submit

June 11, 2019

Conditions

Keywords

Monosodium glutamateAmino acidsGlucose tolerance

Outcome Measures

Primary Outcomes (1)

  • Glutamate

    Circulating and intramuscular concentrations by HPLC

    ~ 2 hours post-ingestion

Secondary Outcomes (5)

  • Glucose

    ~ 2 hours post-ingestion

  • Skeletal muscle glucose uptake

    ~ 2 hours post-ingestion

  • Insulin

    ~ 2 hours post-ingestion

  • C-peptide

    ~ 2 hours post-ingestion

  • Aspartate

    ~ 2 hours post-ingestion

Study Arms (3)

MSG + CHO

EXPERIMENTAL

Participants will ingest 150 mg/kg body mass monosodium glutamate followed by 75 g dextrose.

Dietary Supplement: MSGDietary Supplement: CHO

MSG + placebo B

ACTIVE COMPARATOR

Participants will ingest 150 mg/kg body mass monosodium glutamate followed by a non-caloric, flavoured placebo.

Dietary Supplement: MSGDietary Supplement: Placebo B

Placebo A + CHO

ACTIVE COMPARATOR

Participants will ingest placebo capsules followed by 75 g dextrose.

Dietary Supplement: CHODietary Supplement: Placebo A

Interventions

MSGDIETARY_SUPPLEMENT

150 mg/kg body mass monosodium glutamate (MSG).

MSG + CHOMSG + placebo B
CHODIETARY_SUPPLEMENT

75g CHO (i.e. dextrose)

MSG + CHOPlacebo A + CHO
Placebo ADIETARY_SUPPLEMENT

A non-caloric placebo composed of table salt (NaCl) and sucralose (Splenda).

Placebo A + CHO
Placebo BDIETARY_SUPPLEMENT

A non-caloric placebo composed of flavoured water.

MSG + placebo B

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI in the normal or overweight range (18.5-30.0 kg/m2)
  • Weight stable for the past 6 months
  • Participate in aerobic and/or resistance-type exercise 3-5 times per week (no more then 2 hours per session and/or 5 sessions per week)
  • Fasting blood glucose \< 6.0 mM
  • Resting blood pressure \< 140/90 mmHg
  • Answer "no" to all questions on the Get Active Questionnaire (GAQ)

You may not qualify if:

  • Smoking
  • Known allergy or intolerance to MSG
  • Diabetes, cancer, or other metabolic disorders
  • Cardiac or gastrointestinal problems
  • Infectious disease
  • Injuries that prevent safe participation and exercise or instructions from healthcare provider to refrain from exercise
  • Barium swallow or nuclear medicine scan in the previous 3 weeks
  • If receiving a DXA scan will cause the participant to exceed the maximum trivial dose of radiation per year
  • Prescription anti-coagulant or anti-platelet medication (e.g. warfarin, heparin, clopiodogrel)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

Related Publications (12)

  • Gibala MJ, MacLean DA, Graham TE, Saltin B. Anaplerotic processes in human skeletal muscle during brief dynamic exercise. J Physiol. 1997 Aug 1;502 ( Pt 3)(Pt 3):703-13. doi: 10.1111/j.1469-7793.1997.703bj.x.

    PMID: 9279819BACKGROUND
  • Di Sebastiano KM, Bell KE, Barnes T, Weeraratne A, Premji T, Mourtzakis M. Glutamate supplementation is associated with improved glucose metabolism following carbohydrate ingestion in healthy males. Br J Nutr. 2013 Dec;110(12):2165-72. doi: 10.1017/S0007114513001633. Epub 2013 Jun 11.

    PMID: 23750536BACKGROUND
  • Chevassus H, Renard E, Bertrand G, Mourand I, Puech R, Molinier N, Bockaert J, Petit P, Bringer J. Effects of oral monosodium (L)-glutamate on insulin secretion and glucose tolerance in healthy volunteers. Br J Clin Pharmacol. 2002 Jun;53(6):641-3. doi: 10.1046/j.1365-2125.2002.01596.x.

    PMID: 12047489BACKGROUND
  • Hosaka H, Kusano M, Zai H, Kawada A, Kuribayashi S, Shimoyama Y, Nagoshi A, Maeda M, Kawamura O, Mori M. Monosodium glutamate stimulates secretion of glucagon-like peptide-1 and reduces postprandial glucose after a lipid-containing meal. Aliment Pharmacol Ther. 2012 Nov;36(9):895-903. doi: 10.1111/apt.12050.

    PMID: 22978669BACKGROUND
  • Bertrand G, Gross R, Puech R, Loubatieres-Mariani MM, Bockaert J. Evidence for a glutamate receptor of the AMPA subtype which mediates insulin release from rat perfused pancreas. Br J Pharmacol. 1992 Jun;106(2):354-9. doi: 10.1111/j.1476-5381.1992.tb14340.x.

    PMID: 1382779BACKGROUND
  • Bertrand G, Puech R, Loubatieres-Mariani MM, Bockaert J. Glutamate stimulates insulin secretion and improves glucose tolerance in rats. Am J Physiol. 1995 Sep;269(3 Pt 1):E551-6. doi: 10.1152/ajpendo.1995.269.3.E551.

    PMID: 7573433BACKGROUND
  • Mourtzakis M, Graham TE. Glutamate ingestion and its effects at rest and during exercise in humans. J Appl Physiol (1985). 2002 Oct;93(4):1251-9. doi: 10.1152/japplphysiol.00111.2002.

    PMID: 12235022BACKGROUND
  • Graham TE, MacLean DA. Ammonia and amino acid metabolism in skeletal muscle: human, rodent and canine models. Med Sci Sports Exerc. 1998 Jan;30(1):34-46. doi: 10.1097/00005768-199801000-00006.

    PMID: 9475642BACKGROUND
  • Graham TE, Turcotte LP, Kiens B, Richter EA. Effect of endurance training on ammonia and amino acid metabolism in humans. Med Sci Sports Exerc. 1997 May;29(5):646-53. doi: 10.1097/00005768-199705000-00010.

    PMID: 9140902BACKGROUND
  • Wagenmakers AJ. Muscle amino acid metabolism at rest and during exercise: role in human physiology and metabolism. Exerc Sport Sci Rev. 1998;26:287-314.

    PMID: 9696993BACKGROUND
  • Graham TE, Sgro V, Friars D, Gibala MJ. Glutamate ingestion: the plasma and muscle free amino acid pools of resting humans. Am J Physiol Endocrinol Metab. 2000 Jan;278(1):E83-9. doi: 10.1152/ajpendo.2000.278.1.E83.

    PMID: 10644540BACKGROUND
  • DeFronzo RA. Glucose intolerance and aging. Diabetes Care. 1981 Jul-Aug;4(4):493-501. doi: 10.2337/diacare.4.4.493.

    PMID: 7049632BACKGROUND

MeSH Terms

Interventions

Sodium Glutamate

Intervention Hierarchy (Ancestors)

Glutamic AcidGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Study Officials

  • Marina Mourtzakis, PhD

    University of Waterloo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2018

First Posted

February 7, 2018

Study Start

March 19, 2018

Primary Completion

October 2, 2018

Study Completion

October 2, 2018

Last Updated

June 12, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations