Nutrition InterventionNCT02446106
Monosodium L-glutamate (MSG) on Satiety
A study testing Soup with MSG in people with Nutrition Intervention, run by Ajinomoto Co., Inc. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nutrition Intervention
- What is being tested?
- Soup with MSG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2012to Oct 2012
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leatherhead Food Research
Leatherhead, Surrey, KT22 7RY
About this study
Official title: The Effect of Monosodium L-glutamate (MSG) on Satiety and Energy Intake in Overweight and Obese Women
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.
Read the detailed description
The study is a randomized, 2-arm, double-blind, placebo-controlled, Latin square cross-over clinical trial to assess the impact of 0.5% MSG on total and meal/snack-specific energy intake and on subjective ratings of appetite compared to sodium. Subjects will partake in an adaptation visit to avoid first order effects and will not be included in the randomization.
A total of 75 healthy premenopausal women aged 19 to 60 y (inclusive) will be randomized to a sequence of test product administration. Participants will consume 1 of 2 test products, based on randomization sequence at each test period visit. Carrot and coriander soup (0.5% MSG + 0.48% salt) or negative control match for sodium (no MSG + 0.635% salt).
Participants will be required to meet several inclusion and exclusion criteria, which will be assessed at the screening visit, including a health questionnaire, medical/medication history, eating behavior questionnaires, depression questionnaire and anthropometric measurements. After assessment of the eligibility criteria (see Eligibility section) at the screening visit, qualified participants will be invited to participate in the study and will be familiarized with the completion of VAS for subjective ratings of hunger, fullness, satiety and desire to eat.
Over a 3-week period, participants will come to the test facility on three occasions to complete the study with a one week wash-out period between each visit. Participants will fast overnight before each visit and consume the same evening meal before each test day.
Participants arrive at the research center at approximately 8:15am. Right before serving the breakfast meal, participants will be asked to complete a satiety rating questionnaire (using visual analogue scale (VAS)). At 8:30am, participants will consume breakfast (cereal and milk). Immediately after eating breakfast participants will complete another VAS questionnaire as well as a taste/liking meal evaluation. Thereafter, VAS will be completed at 30 minute intervals.
Four hours after the breakfast meal (at 12:30pm), participants will be given one of the test products (carrot and coriander soup with or without MSG) based on their randomization schedule. Subjects will have 10 min to consume the soup in its entirety. Following test product/soup intake, subjects will complete a taste/liking meal evaluation and VAS questionnaire. Immediately after completion of the questionnaire (12:40pm), an ad lib lunch buffet will be provided and participants will be instructed to eat as much as or as little as they desire (within 30 min) until comfortably full, followed by completing a taste/liking meal evaluation and VAS questionnaire. Thereafter, VAS will be completed at 30 minute intervals.
At 3:30pm, participants will be provided with their second portion of the test product to consume within 10 min, followed by completing a taste/liking meal evaluation and VAS questionnaire. Immediately after test soup administration and completing questionnaires, an ad lib snack buffet will be provided and participants will be instructed to eat as much as or as little as they desire within 20 min, followed by completing a taste/liking meal evaluation and VAS questionnaire. VAS assessment will continue at 30 min intervals thereafter until 5:00pm ending the study day. Participants' next visit will be scheduled after 1 week wash-out period: all procedures are identical with the exception of the test treatment soup consumed by participants.
- Conditions
- Nutrition Intervention
- Being tested
- Soup with MSG, Control soup no MSG
- Keywords
- Monosodium L-Glutamate (MSG), Satiety, Soups, Energy Intake, Snack Intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soup with MSGDietary supplement
0.5% MSG + 0.48% salt
Control soup no MSGDietary supplement
Negative control match for sodium (no MSG + 0.635% salt)
| Study group | Role | What they receive |
|---|---|---|
| Soup with MSG | Active comparator | 0.5% MSG incorporated into a soup preload Receives: Dietary Supplement: Soup with MSG |
| Control Soup | Placebo comparator | Negative control match for sodium (no MSG + 0.635% salt) Receives: Dietary Supplement: Control soup no MSG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
food will be measured before and after using a food scale (weight out and in)
Measured: 8 hours 30 min Postprandial Study
The difference in energy intake of snack only compared with a control
food will be measured before and after using a food scale
Measured: 8 hours 30 min Postprandial Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startJun 2012
- Primary completionSep 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajinomoto Co., Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sonia Pombo, PhD, Principal investigator, Nutrition & Health Enquires, Leatherhead Food Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02446106
- Sponsor's protocol ID
- 12/NS/0068
- Status last verified
- May 2015
- First submitted
- 8 May 2015
- Last updated
- 18 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Monosodium L-glutamate (MSG) on Satiety and Energy Intake in Overweight and Obese Women
- ClinicalTrials.gov ID
- NCT02446106
- Acronym / sponsor ID
- 12/NS/0068
- Conditions
- Nutrition Intervention
- Keywords
- Monosodium L-Glutamate (MSG), Satiety, Soups, Energy Intake, Snack Intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ajinomoto Co., Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 18 May 2015 (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 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.
Detailed description
The study is a randomized, 2-arm, double-blind, placebo-controlled, Latin square cross-over clinical trial to assess the impact of 0.5% MSG on total and meal/snack-specific energy intake and on subjective ratings of appetite compared to sodium. Subjects will partake in an adaptation visit to avoid first order effects and will not be included in the randomization.
A total of 75 healthy premenopausal women aged 19 to 60 y (inclusive) will be randomized to a sequence of test product administration. Participants will consume 1 of 2 test products, based on randomization sequence at each test period visit. Carrot and coriander soup (0.5% MSG + 0.48% salt) or negative control match for sodium (no MSG + 0.635% salt).
Participants will be required to meet several inclusion and exclusion criteria, which will be assessed at the screening visit, including a health questionnaire, medical/medication history, eating behavior questionnaires, depression questionnaire and anthropometric measurements. After assessment of the eligibility criteria (see Eligibility section) at the screening visit, qualified participants will be invited to participate in the study and will be familiarized with the completion of VAS for subjective ratings of hunger, fullness, satiety and desire to eat.
Over a 3-week period, participants will come to the test facility on three occasions to complete the study with a one week wash-out period between each visit. Participants will fast overnight before each visit and consume the same evening meal before each test day.
Participants arrive at the research center at approximately 8:15am. Right before serving the breakfast meal, participants will be asked to complete a satiety rating questionnaire (using visual analogue scale (VAS)). At 8:30am, participants will consume breakfast (cereal and milk). Immediately after eating breakfast participants will complete another VAS questionnaire as well as a taste/liking meal evaluation. Thereafter, VAS will be completed at 30 minute intervals.
Four hours after the breakfast meal (at 12:30pm), participants will be given one of the test products (carrot and coriander soup with or without MSG) based on their randomization schedule. Subjects will have 10 min to consume the soup in its entirety. Following test product/soup intake, subjects will complete a taste/liking meal evaluation and VAS questionnaire. Immediately after completion of the questionnaire (12:40pm), an ad lib lunch buffet will be provided and participants will be instructed to eat as much as or as little as they desire (within 30 min) until comfortably full, followed by completing a taste/liking meal evaluation and VAS questionnaire. Thereafter, VAS will be completed at 30 minute intervals.
At 3:30pm, participants will be provided with their second portion of the test product to consume within 10 min, followed by completing a taste/liking meal evaluation and VAS questionnaire. Immediately after test soup administration and completing questionnaires, an ad lib snack buffet will be provided and participants will be instructed to eat as much as or as little as they desire within 20 min, followed by completing a taste/liking meal evaluation and VAS questionnaire. VAS assessment will continue at 30 min intervals thereafter until 5:00pm ending the study day. Participants' next visit will be scheduled after 1 week wash-out period: all procedures are identical with the exception of the test treatment soup consumed by participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soup with MSG | Active comparator | Dietary Supplement: Soup with MSG0.5% MSG incorporated into a soup preload |
| Control Soup | Placebo comparator | Dietary Supplement: Control soup no MSGNegative control match for sodium (no MSG + 0.635% salt) |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
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 with MSG0.5% MSG + 0.48% salt | Dietary supplement | Soup with MSG |
| Control soup no MSGNegative control match for sodium (no MSG + 0.635% salt) | Dietary supplement | Control Soup |
Primary outcome
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).
Time frame: 8 hours 30 min Postprandial Study
food will be measured before and after using a food scale (weight out and in)
2 secondary outcomes
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).
Time frame: 8 hours 30 min Postprandial Study
The difference in energy intake of snack only compared with a control
Time frame: 8 hours 30 min Postprandial Study
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 18 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.
Sonia Pombo, PhD principal investigator
Nutrition & Health Enquires, Leatherhead Food Research
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 with MSG in people with Nutrition Intervention, run by Ajinomoto Co., Inc. at 1 site in United Kingdom.
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 11 inclusion and 11 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 18 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 Kingdom. 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?
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). (time frame: 8 hours 30 min Postprandial Study). 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 18 May 2015.