NCT01761045

Brief Summary

The objective of this study is to confirm that Monosodium L-Glutamate (MSG) supplementation, both alone or in combination with Nucleic Acid (IMP), enhances satiety and decreases food intakes at the next meal in healthy female adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2010

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
Last Updated

February 11, 2013

Status Verified

February 1, 2013

Enrollment Period

6 months

First QC Date

January 2, 2013

Last Update Submit

February 7, 2013

Conditions

Nutrition Intervention

Keywords

Monosodium L-Glutamate (MSG)Nucleic Acid (IMP)SatietyGastrointestinal SensationConsommé SoupsSnack Intake

Outcome Measures

Primary Outcomes (1)

  • Differences in food intake and subjective satiety motivational responses to treatments

    4-hr postprandial study

Secondary Outcomes (1)

  • Correlation between genetic makeup of the subject and the primary efficacy endpoints.

    3 weeks

Study Arms (3)

Soup 1

ACTIVE COMPARATOR

Consommé soup with Monosodium L-Glutamate (MSG)

Dietary Supplement: Soup 1

Soup 2

ACTIVE COMPARATOR

Consommé soup with Monosodium L-Glutamate (MSG) and Nucleic Acid (IMP)

Dietary Supplement: Soup 2

Soup 3

PLACEBO COMPARATOR

Placebo soup with no Monosodium L-Glutamate (MSG) or Nucleic Acid (IMP)

Dietary Supplement: Soup 3

Interventions

Soup 1DIETARY_SUPPLEMENT

Consommé soup with Monosodium L-Glutamate (MSG)

Soup 1
Soup 2DIETARY_SUPPLEMENT

Consommé soup with Monosodium L-Glutamate (MSG) and Nucleic Acid (IMP)

Soup 2
Soup 3DIETARY_SUPPLEMENT

Placebo soup with no Monosodium L-Glutamate (MSG) or Nucleic Acid (IMP)

Soup 3

Eligibility Criteria

Age30 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Female, 30 to 45 yrs old
  • Non-smoker
  • Non-heavy Drinker
  • BMI between 18.5 and 25.0 inclusive at the screening visit

You may not qualify if:

  • History or presence of any serious and/or chronic medical or clinical disease, including renal disease, hepatic (biliary) disease, uncontrolled hypertension or uncontrolled thyroid disease, surgical conditions, cardiovascular disease other than mild hypertension or dyslipidemias, myocardial infarction, or other conditions that in the opinion of the investigator may increase the risk of participation or compromise/confound the study results
  • History or diagnosis of type 1 or 2 diabetes mellitus or other uncontrolled endocrine disease
  • Dysgeusia
  • Any history of gastrointestinal disease or currently on treatment for a digestive disease
  • Eating disorder or abnormal eating habits
  • Undergone a recent significant weight change (gain or loss)
  • Participating on a weight-loss program within the past 6 months prior to entry into the study
  • Taking any medications for the alimentary system
  • Allergy or sensitivity to foods or food additives
  • History of using habitual drugs and/or alcohol abuse within the past year
  • Psychosis and/or suffering from any other condition(s) which might render the individual unable to comply with the protocol or place subjects at increased risk at the discretion of the PI
  • Used any investigational drug or product within the 1 month prior to the screening visit
  • On special diet such as vegetarian
  • Dislike the preloading soup and/or the provided lunch and/or study snacks
  • Currently breast feeding and/or pregnant in the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IBERICA Clinical Research Center

Eatontown, New Jersey, 07724, United States

Location

Related Publications (1)

  • Imada T, Hao SS, Torii K, Kimura E. Supplementing chicken broth with monosodium glutamate reduces energy intake from high fat and sweet snacks in middle-aged healthy women. Appetite. 2014 Aug;79:158-65. doi: 10.1016/j.appet.2014.04.011. Epub 2014 Apr 23.

    PMID: 24768895DERIVED

Study Officials

  • Joel S Ross, MD

    The Memory Enhancement Center of America, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2013

First Posted

January 4, 2013

Study Start

July 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

February 11, 2013

Record last verified: 2013-02

Locations

US(1)