ObesityNCT01410838
Effects of Monosodium Glutamate on Energy Balance and Eating Behavior
A study testing Broth in people with Obesity and Weight Gain, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
Trial summary
This study will test whether regular consumption of Monosodium Glutamate (MSG) immediately prior to each of the three major meals (breakfast, lunch, dinner) inhibits body weight and fat regain following a period of moderate, yet clinically significant weight loss. Read more about this study
- Who is it for?
- Ages 19 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Gain, Food Preferences
- What is being tested?
- Broth
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Aug 2014
- 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 19 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women
- Age 19-45
- BMI 27-35
- Blood pressure <140/90
- Non-smoking
Who cannot join
- Anemic: hgb < 11.5 mg/dL
- Sensitivity to MSG (self reported)
- Pregnant or planning to get pregnant
- Taking medication for hypertension, depression, or weight loss
- Diabetic
- Vegetarian
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- MRI Contraindications: internal metal, braces on teeth, history of metal in the eye, claustrophobia
- blindness or heavily corrected vision
- not fluent in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Human Nutrition Center, University of California Davis
Davis, California, 95616
About this study
Official title: Effects of Ingesting Monosodium Glutamate (MSG) on Energy Balance and Eating Behavior Following Moderate Energy Restriction and Weight Loss in Overweight Women
This study will test whether regular consumption of Monosodium Glutamate (MSG) immediately prior to each of the three major meals (breakfast, lunch, dinner) inhibits body weight and fat regain following a period of moderate, yet clinically significant weight loss.
Read the detailed description
The proposed study enables us to assess the long term effects of consuming MSG on body weight regain following weight loss.
- Conditions
- Obesity, Weight Gain, Food Preferences
- Being tested
- Broth
- Keywords
- Obesity, Food preferences, Eating Behavior
- Medical subject headings
- Obesity, Weight Gain, Food Preferences, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrothOther
200 mL of sodium chloride containing broth, consumed three times per day
BrothOther
200 mL of MSG containing broth consumed three times per day
| Study group | Role | What they receive |
|---|---|---|
| Broth- NaCl | Placebo comparator | Sodium chloride containing broth matched for sodium content to the MSG broth Receives: Other: Broth |
| Broth- MSG | Active comparator | MSG containing broth with the same sodium content as the placebo comparator. Receives: Other: Broth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Subjects will have their body weight measured to determine the effect of MSG on body weight regain following weight loss.
Measured: weeks 11, 12, and 25
Secondary outcomes (3)
Change in body fat
Volunteers will have their body fat measured by DEXA (Dual X-ray Absorptiometry) to determine the effect of MSG on body fat regain following weight loss.
Measured: weeks 11 and 25
Change in eating behavior
The effect of MSG on eating behavior will be measured using questionnaires, sensory evaluation testing, stress responsivity, and liking and wanting tests, and appetite assessments.
Measured: weeks 11, 12 and 25
Change in resting energy expenditure
The effect of MSG on resting energy expenditure will be measured using respiratory gas exchange using a metabolic cart system.
Measured: weeks 11, 12, and 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- Ajinomoto USA, INC.
- Responsible party
- Sponsor
- Investigators
- Kevin Laugero, PhD, Principal investigator, WHNRC, ARS, University of California Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410838
- Sponsor's protocol ID
- WHNRC 222718-2
- Status last verified
- Aug 2014
- First submitted
- 3 Aug 2011
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ingesting Monosodium Glutamate (MSG) on Energy Balance and Eating Behavior Following Moderate Energy Restriction and Weight Loss in Overweight Women
- ClinicalTrials.gov ID
- NCT01410838
- Acronym / sponsor ID
- WHNRC 222718-2
- Conditions
- Obesity, Weight Gain, Food Preferences
- Keywords
- Obesity, Food preferences, Eating Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Collaborators
- Ajinomoto USA, INC.
- Study start
- Aug 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 5 Aug 2011 (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.
This study will test whether regular consumption of Monosodium Glutamate (MSG) immediately prior to each of the three major meals (breakfast, lunch, dinner) inhibits body weight and fat regain following a period of moderate, yet clinically significant weight loss.
Detailed description
The proposed study enables us to assess the long term effects of consuming MSG on body weight regain following weight loss.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Broth- NaCl | Placebo comparator | Other: BrothSodium chloride containing broth matched for sodium content to the MSG broth |
| Broth- MSG | Active comparator | Other: BrothMSG containing broth with the same sodium content as the placebo comparator. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women
- Age 19-45
- BMI 27-35
- Blood pressure <140/90
- Non-smoking
Key exclusion criteria (9 listed)
- Anemic: hgb < 11.5 mg/dL
- Sensitivity to MSG (self reported)
- Pregnant or planning to get pregnant
- Taking medication for hypertension, depression, or weight loss
- Diabetic
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 |
|---|---|---|
| Broth200 mL of sodium chloride containing broth, consumed three times per day | Other | Broth- NaCl |
| Broth200 mL of MSG containing broth consumed three times per day | Other | Broth- MSG |
Primary outcome
Change in body weight
Time frame: weeks 11, 12, and 25
Subjects will have their body weight measured to determine the effect of MSG on body weight regain following weight loss.
3 secondary outcomes
Change in body fat
Time frame: weeks 11 and 25
Change in eating behavior
Time frame: weeks 11, 12 and 25
Change in resting energy expenditure
Time frame: weeks 11, 12, and 25
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 21 May 2015.
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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.
Kevin Laugero, PhD principal investigator
WHNRC, ARS, University of California Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Broth in people with Obesity and Weight Gain, run by USDA, Western Human Nutrition Research Center 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 5 inclusion and 9 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 21 May 2015. 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?
Change in body weight (time frame: weeks 11, 12, and 25). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2015.