ObesityNCT01956838
The Effect of Bitter, Umami and Sweet Tastants on Food Intake
A study testing umami, bitter and sweet in people with Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: The appearance of tastants in the small intestine can result in the activation of a negative feedback mechanism from different parts of the intestine to the stomach, the small intestine and to the central nervous system. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- umami, bitter and sweet
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2013to 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Based on medical history and previous examination, no gastrointestinal complaints can be defined.
- Age between 18 and 65 years. This study will include healthy adult subjects (male and female). Women must be taking contraceptives.
- BMI between 18 and 25 kg/m2)
- Weight stable over at least the last 6 months
Who cannot join
- History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.
- Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
- Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)
- Dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological dynamic)
- Pregnancy, lactation
Show all 13Show fewer
- Excessive alcohol consumption (>20 alcoholic consumptions per week)
- Smoking
- Blood donation within 3 months before the study period
- Self-admitted HIV-positive state
- Weight <60kg
- Non-tasters of sweet, bitter or umami
- Evidence of MSG-hypersensitivity or Chinese restaurant syndrome
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Maastricht
About this study
Rationale: The appearance of tastants in the small intestine can result in the activation of a negative feedback mechanism from different parts of the intestine to the stomach, the small intestine and to the central nervous system. These processes inhibit food processing, appetite sensations and food intake, and furthermore they increase feelings of satiety and satiation. We will investigate the effects of intraduodenal infusion of quinine 75mg (bitter), rebaudioside A 540mg (sweet), monosodium glutamate 2g (umami), a combination of these tastants (quinine, rebaudioside A, monosodium glutamate) and placebo (5 test days in total) on ad libitum food intake, satiation and in vivo release of the gut satiety peptides CCK and GLP-1.
Study design: To assess the effect of intraduodenal infusion of single ingredients and a combination of tastants (bitter, umami and sweet) on ad libitum food intake.
Read more
Secondary Objective(s):
- To investigate the effect of intraduodenal delivery of a combination of tastants on satiation.
- To assess the effect of intraduodenal delivery of a combination of tastants on gastrointestinal hormone release.
- To assess the effects of the tastants quinine, rebaudioside A and monosodium glutamate on the parameters as mentioned under the primary objective, and under secondary objectives 1 and 2.
- To compare the effects, as mentioned under the primary objective, and under secondary objectives 1 and 2, of the combination of tastants to those of the three single tastants quinine, rebaudioside A and monosodium glutamate.
- Conditions
- Obesity
- Being tested
- umami, bitter, sweet
- Keywords
- food intake, tastants, obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umamiDietary supplement
intraduodenal infusion of umami tastant
bitterDietary supplement
intraduodenal infusion of bitter tastant
sweetDietary supplement
intraduodenal infusion of sweet tastant
| Study group | Role | What they receive |
|---|---|---|
| Umami | Experimental | intraduodenal infusion of umami Receives: Dietary Supplement: umami |
| sweet | Experimental | intraduodenal infusion of sweet tastant Receives: Dietary Supplement: sweet |
| bitter | Experimental | intraduodenal infusion of bitter tastant Receives: Dietary Supplement: bitter |
| combination | Experimental | intraduodenal infusion of a combination of tastants (umami, bitter and sweet) Receives: Dietary Supplement: umami; Dietary Supplement: bitter; Dietary Supplement: sweet |
| placebo | Placebo comparator | intraduodenal infusion of placebo (tap water) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad libitum meal intake
Difference in ad libitum meal intake (as measured during ad libitum pasta meal). At end of the testday
Measured: 5 weeks
Secondary outcomes (2)
Satiation
Difference in satiation (as measured by VAS) per time point
Measured: 5 weeks
Gut hormones
Measurements in plasma levels of the gut hormones CCK, GLP-1, insulin and glucose
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2014
- Study completionAug 2014
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 ObesityStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof Masclee, MD,PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956838
- Sponsor's protocol ID
- NL44428.068.13/METC 13-2-025
- Status last verified
- Oct 2014
- First submitted
- 17 Sep 2013
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
van Avesaat M, Troost FJ, Ripken D, Peters J, Hendriks HF, Masclee AA. Intraduodenal infusion of a combination of tastants decreases food intake in humans. Am J Clin Nutr. 2015 Oct;102(4):729-35. doi: 10.3945/ajcn.115.113266. Epub 2015 Aug 19.
PubMed 26289437
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bitter, Umami and Sweet Tastants on Food Intake
- ClinicalTrials.gov ID
- NCT01956838
- Acronym / sponsor ID
- NL44428.068.13/METC 13-2-025
- Conditions
- Obesity
- Keywords
- food intake, tastants, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 8 Oct 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.
Rationale: The appearance of tastants in the small intestine can result in the activation of a negative feedback mechanism from different parts of the intestine to the stomach, the small intestine and to the central nervous system. These processes inhibit food processing, appetite sensations and food intake, and furthermore they increase feelings of satiety and satiation. We will investigate the effects of intraduodenal infusion of quinine 75mg (bitter), rebaudioside A 540mg (sweet), monosodium glutamate 2g (umami), a combination of these tastants (quinine, rebaudioside A, monosodium glutamate) and placebo (5 test days in total) on ad libitum food intake, satiation and in vivo release of the gut satiety peptides CCK and GLP-1.
Study design: To assess the effect of intraduodenal infusion of single ingredients and a combination of tastants (bitter, umami and sweet) on ad libitum food intake.
Secondary Objective(s):
- To investigate the effect of intraduodenal delivery of a combination of tastants on satiation.
- To assess the effect of intraduodenal delivery of a combination of tastants on gastrointestinal hormone release.
- To assess the effects of the tastants quinine, rebaudioside A and monosodium glutamate on the parameters as mentioned under the primary objective, and under secondary objectives 1 and 2.
- To compare the effects, as mentioned under the primary objective, and under secondary objectives 1 and 2, of the combination of tastants to those of the three single tastants quinine, rebaudioside A and monosodium glutamate.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Umami | Experimental | Dietary Supplement: umamiintraduodenal infusion of umami |
| sweet | Experimental | Dietary Supplement: sweetintraduodenal infusion of sweet tastant |
| bitter | Experimental | Dietary Supplement: bitterintraduodenal infusion of bitter tastant |
| combination | Experimental | Dietary Supplement: umami, Dietary Supplement: bitter, Dietary Supplement: sweetintraduodenal infusion of a combination of tastants (umami, bitter and sweet) |
| placebo | Placebo comparator | –intraduodenal infusion of placebo (tap water) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Based on medical history and previous examination, no gastrointestinal complaints can be defined.
- Age between 18 and 65 years. This study will include healthy adult subjects (male and female). Women must be taking contraceptives.
- BMI between 18 and 25 kg/m2)
- Weight stable over at least the last 6 months
Key exclusion criteria (13 listed)
- History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.
- Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
- Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)
- Dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological dynamic)
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 |
|---|---|---|
| umamiintraduodenal infusion of umami tastant | Dietary supplement | Umami, combination |
| bitterintraduodenal infusion of bitter tastant | Dietary supplement | bitter, combination |
| sweetintraduodenal infusion of sweet tastant | Dietary supplement | combination, sweet |
Primary outcome
Ad libitum meal intake
Time frame: 5 weeks
Difference in ad libitum meal intake (as measured during ad libitum pasta meal). At end of the testday
2 secondary outcomes
Satiation
Time frame: 5 weeks
Gut hormones
Time frame: 5 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 15 Oct 2014.
- Derived from this study: PubMed 26289437van Avesaat M, Troost FJ, Ripken D, Peters J, Hendriks HF, Masclee AA. Intraduodenal infusion of a combination of tastants decreases food intake in humans. Am J Clin Nutr. 2015 Oct;102(4):729-35. doi: 10.3945/ajcn.115.113266. Epub 2015 Aug 19.
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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.
Prof Masclee, MD,PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing umami, bitter and sweet in people with Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
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 13 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 15 Oct 2014. 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 Netherlands. 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?
Ad libitum meal intake (time frame: 5 weeks). 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 NCT01956838, 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 15 Oct 2014.