NCT02446106

Brief Summary

The objective of this study is to compare energy intake following consumption 0.5% MSG versus a control with no added MSG and matched for sodium in healthy non-smoking premenopausal female adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 18, 2015

Completed
Last Updated

May 18, 2015

Status Verified

May 1, 2015

Enrollment Period

3 months

First QC Date

May 8, 2015

Last Update Submit

May 15, 2015

Conditions

Keywords

Monosodium L-Glutamate (MSG)SatietySoupsEnergy IntakeSnack Intake

Outcome Measures

Primary Outcomes (1)

  • The difference in total energy intake (lunch and snack) compared with a control, as determined by food amount that subject consumed using a food scale (weigh foods before and after).

    food will be measured before and after using a food scale (weight out and in)

    8 hours 30 min Postprandial Study

Secondary Outcomes (2)

  • The difference in energy intake only at lunch compared with a control, as determined by food amount that subject consumed using a food scale (weigh foods before and after).

    8 hours 30 min Postprandial Study

  • The difference in energy intake of snack only compared with a control

    8 hours 30 min Postprandial Study

Other Outcomes (2)

  • The difference in subjective feelings of appetite using visual analogue scales (VAS), compared with a negative control

    8 hours 30 min Postprandial Study

  • Taste meal evaluation, including soup liking

    8 hours 30 min Postprandial Study

Study Arms (2)

Soup with MSG

ACTIVE COMPARATOR

0.5% MSG incorporated into a soup preload

Dietary Supplement: Soup with MSG

Control Soup

PLACEBO COMPARATOR

Negative control match for sodium (no MSG + 0.635% salt)

Dietary Supplement: Control soup no MSG

Interventions

Soup with MSGDIETARY_SUPPLEMENT

0.5% MSG + 0.48% salt

Soup with MSG
Control soup no MSGDIETARY_SUPPLEMENT

Negative control match for sodium (no MSG + 0.635% salt)

Control Soup

Eligibility Criteria

Age19 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Premenopausal Female, 19 to 60 yrs old
  • Non-smoker
  • Non-heavy Drinker
  • BMI between 25 and 39.9 inclusive at the screening visit (with average BMI 30)
  • no reported current or previous metabolic diseases or chronic gastrointestinal disorders
  • no medically prescribed diet, no slimming diet, used to eating 3 meals a day and snacking
  • No blood donation during the study
  • Reported intense sporting activities ≤ 10h/w
  • Reported alcohol consumption ≤14 units/w
  • Informed consent signed
  • Recruitment form filled out

You may not qualify if:

  • Smoker
  • Vegetarian
  • Disliking the meals provided on the test day, have allergy or intolerance to test products or study meals
  • Use of medication which interferes with study measurements (as judged by the study physician).
  • Possible eating disorder (measured by SCOFF questionnaire score \>1)
  • Current depression measured by BDI \<10
  • Pregnant during the study period or in the six months prior to pre-study investigation
  • Reported lactating 6 weeks before pre-study investigation and during the study
  • Reported weight loss or gain ≥ 10 % of bodyweight during a period of six months before pre-study examination.
  • Eating disorder (measured by SCOFF questionnaire, ≥2 "yes" responses)
  • Reported participation in another biomedical trial 1 month before the start of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leatherhead Food Research

Leatherhead, Surrey, KT22 7RY, United Kingdom

Location

MeSH Terms

Interventions

Sodium Glutamate

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Sonia Pombo, PhD

    Nutrition & Health Enquires, Leatherhead Food Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2015

First Posted

May 18, 2015

Study Start

June 1, 2012

Primary Completion

September 1, 2012

Study Completion

October 1, 2012

Last Updated

May 18, 2015

Record last verified: 2015-05

Locations