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Effect of Monosodium L-Glutamate (MSG) and Nucleic Acid (IMP) on Satiety and Food Intake

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ClinicalTrials.gov Identifier: NCT01761045
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : February 11, 2013
Sponsor:
Information provided by (Responsible Party):
Ajinomoto Co., Inc.

Tracking Information
First Submitted Date  ICMJE January 2, 2013
First Posted Date  ICMJE January 4, 2013
Last Update Posted Date February 11, 2013
Study Start Date  ICMJE July 2010
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2013)
Differences in food intake and subjective satiety motivational responses to treatments [ Time Frame: 4-hr postprandial study ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 2, 2013)
Difference between changes in the subjective satiety motivational responses to soup treatments [ Time Frame: 4-hr postprandial study ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2013)
Correlation between genetic makeup of the subject and the primary efficacy endpoints. [ Time Frame: 3 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2013)
  • Differences in soup rating responses [ Time Frame: 3 weeks ]
  • Differences in snack intake (Kcal) by test snack type among soup treatments [ Time Frame: 3 weeks ]
  • Difference in total snack intake (Kcal) among soup treatments [ Time Frame: 3 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Monosodium L-Glutamate (MSG) and Nucleic Acid (IMP) on Satiety and Food Intake
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Crossover Clinical Study of Monosodium L-Glutamate (MSG) and Nucleic Acid (IMP) to Evaluate the Effects on Satiety and Food Intakes at the Next Meal in Healthy Adults
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.
Detailed Description

The study is a randomized, double-blind, placebo-controlled, cross-over clinical trial. A total of 80 women aged 30 to 45 y will be randomized to a sequence of test product administration.

Subjects will be required to meet several inclusion and exclusion criteria, which will be assessed at the screening visit, including a general screening questionnaire, medical/medication history, eating disorder questionnaire, eating inventory questionnaire, dietary inventory questionnaire, and anthropometric and vital sign measurements. At the screening visit, a urine sample will be collected for drug and alcohol screening, cotinine level, and pregnancy. Alcohol breath test will be performed as well.

After assessment of the eligibility criteria, qualified subjects will be invited to participate in the study. This study will take approximately 3 weeks to complete.

Subjects will return to the study site within 28 days after the screening visit for testing period 1, followed by 2 additional visits (testing period 2 and 3).

Subjects will consume 1 of 3 treatments, based on randomization sequence at each test period visit: Consommé soup with Monosodium L-Glutamate (MSG), Consommé soup with MSG and Nucleic Acid (IMP), and Placebo soup with no MSG or IMP.

When subjects arrive at the research center at approximately 11:30am, admission procedures will be conducted: an alcohol breath test, food and activity diary review, and vital signs and weight will be measured. If vital sign measurements are elevated, subjects will be rescheduled within 2-3 days. Right before serving the standard lunch meal, subjects will be asked to complete a satiety motivational questionnaire. Subjects will consume the entire standard lunch meal and water within 30 min. Immediately after eating the standard lunch meal, subjects will complete the satiety motivational questionnaire.

Two hours after the standard lunch meal, subjects will be given one of the test soups (based on their randomization) to consume in its entirety, followed by completion of the satiety motivational questionnaire and the soup rating questionnaire. Fifteen minutes from test soup administration, snacks and water (ad lib) will be provided and subjects will be instructed to eat as much as or as little as they desire, followed by completing the satiety motivational questionnaire. At 3 h 15 min and at 4 h, subjects will complete the satiety motivational questionnaire.

Test periods 2 and 3 will be scheduled between 3-14 days after completing test period visit 1: all procedures are identical on each test period visit with the exception of the test treatment soup consumed by subjects.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Nutrition Intervention
Intervention  ICMJE
  • Dietary Supplement: Soup 1
    Consommé soup with Monosodium L-Glutamate (MSG)
  • Dietary Supplement: Soup 2
    Consommé soup with Monosodium L-Glutamate (MSG) and Nucleic Acid (IMP)
  • Dietary Supplement: Soup 3
    Placebo soup with no Monosodium L-Glutamate (MSG) or Nucleic Acid (IMP)
Study Arms  ICMJE
  • Active Comparator: Soup 1
    Consommé soup with Monosodium L-Glutamate (MSG)
    Intervention: Dietary Supplement: Soup 1
  • Active Comparator: Soup 2
    Consommé soup with Monosodium L-Glutamate (MSG) and Nucleic Acid (IMP)
    Intervention: Dietary Supplement: Soup 2
  • Placebo Comparator: Soup 3
    Placebo soup with no Monosodium L-Glutamate (MSG) or Nucleic Acid (IMP)
    Intervention: Dietary Supplement: Soup 3
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 2, 2013)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01761045
Other Study ID Numbers  ICMJE AJU-S002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ajinomoto Co., Inc.
Study Sponsor  ICMJE Ajinomoto Co., Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joel S Ross, MD The Memory Enhancement Center of America, Inc.
PRS Account Ajinomoto Co., Inc.
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP