Nutrition InterventionNCT01761045
Effect of Monosodium L-Glutamate (MSG) and Nucleic Acid (IMP) on Satiety and Food Intake
A study testing Soup 1, Soup 2 and Soup 3 in people with Nutrition Intervention, run by Ajinomoto Co., Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nutrition Intervention
- What is being tested?
- Soup 1, Soup 2 and Soup 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Female, 30 to 45 yrs old
- Non-smoker
- Non-heavy Drinker
- BMI between 18.5 and 25.0 inclusive at the screening visit
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
IBERICA Clinical Research Center
Eatontown, New Jersey, 07724
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Nutrition Intervention
- Being tested
- Soup 1, Soup 2, Soup 3
- Keywords
- Monosodium L-Glutamate (MSG), Nucleic Acid (IMP), Satiety, Gastrointestinal Sensation, Consommé Soups, Snack Intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soup 1Dietary supplement
Consommé soup with Monosodium L-Glutamate (MSG)
Soup 2Dietary supplement
Consommé soup with Monosodium L-Glutamate (MSG) and Nucleic Acid (IMP)
Soup 3Dietary supplement
Placebo soup with no Monosodium L-Glutamate (MSG) or Nucleic Acid (IMP)
| Study group | Role | What they receive |
|---|---|---|
| Soup 1 | Active comparator | Consommé soup with Monosodium L-Glutamate (MSG) Receives: Dietary Supplement: Soup 1 |
| Soup 2 | Active comparator | Consommé soup with Monosodium L-Glutamate (MSG) and Nucleic Acid (IMP) Receives: Dietary Supplement: Soup 2 |
| Soup 3 | Placebo comparator | Placebo soup with no Monosodium L-Glutamate (MSG) or Nucleic Acid (IMP) Receives: Dietary Supplement: Soup 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in food intake and subjective satiety motivational responses to treatments
Measured: 4-hr postprandial study
Secondary outcomes (1)
Correlation between genetic makeup of the subject and the primary efficacy endpoints.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startJul 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutrition InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajinomoto Co., Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joel S Ross, MD, Principal investigator, The Memory Enhancement Center of America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761045
- Sponsor's protocol ID
- AJU-S002
- Status last verified
- Feb 2013
- First submitted
- 2 Jan 2013
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24768895
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01761045
- Acronym / sponsor ID
- AJU-S002
- Conditions
- Nutrition Intervention
- Keywords
- Monosodium L-Glutamate (MSG), Nucleic Acid (IMP), Satiety, Gastrointestinal Sensation, Consommé Soups, Snack Intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ajinomoto Co., Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 4 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Soup 1 | Active comparator | Dietary Supplement: Soup 1Consommé soup with Monosodium L-Glutamate (MSG) |
| Soup 2 | Active comparator | Dietary Supplement: Soup 2Consommé soup with Monosodium L-Glutamate (MSG) and Nucleic Acid (IMP) |
| Soup 3 | Placebo comparator | Dietary Supplement: Soup 3Placebo soup with no Monosodium L-Glutamate (MSG) or Nucleic Acid (IMP) |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Female, 30 to 45 yrs old
- Non-smoker
- Non-heavy Drinker
- BMI between 18.5 and 25.0 inclusive at the screening visit
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soup 1Consommé soup with Monosodium L-Glutamate (MSG) | Dietary supplement | Soup 1 |
| Soup 2Consommé soup with Monosodium L-Glutamate (MSG) and Nucleic Acid (IMP) | Dietary supplement | Soup 2 |
| Soup 3Placebo soup with no Monosodium L-Glutamate (MSG) or Nucleic Acid (IMP) | Dietary supplement | Soup 3 |
Primary outcome
Differences in food intake and subjective satiety motivational responses to treatments
Time frame: 4-hr postprandial study
1 secondary outcome
Correlation between genetic makeup of the subject and the primary efficacy endpoints.
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2013.
- Derived from this study: PubMed 24768895Imada 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.
Related trials for Nutrition Intervention
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
Active, not recruiting
Optimal Digital Weight Loss Treatment for Rural Individuals
Overweight and Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel S Ross, MD principal investigator
The Memory Enhancement Center of America, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soup 1, Soup 2 and Soup 3 in people with Nutrition Intervention, run by Ajinomoto Co., Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in food intake and subjective satiety motivational responses to treatments (time frame: 4-hr postprandial study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01761045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2013.