ObesityNCT03565133
Quinine and Food Intake
A study testing Gastric quinine 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 following food ingestion results in the onset of digestion and absorption but can also 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?
- Gastric quinine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Aug 2018to 15 Aug 2019
- 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 and/or gastrointestinal disorders can be defined.
- Age ≥18 and ≤65 years. This study will include healthy adult subjects (male and female).
- BMI ≥18 and ≤25 kg/m2
- Body weight stable over at least the last 6 months (≤ 5% weight change allowed)
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 that can influence study end-points (to be discussed by medical doctor and principal investigator), including vitamin supplementation, 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 and hysterectomy allowed, and other surgery upon judgement of medical doctor and principle investigator)
- Dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological dynamic)
- Unwillingness to eat lasagna Bolognese meal
Show all 10Show fewer
- Pregnancy, lactation
- Excessive alcohol consumption (>20 alcoholic consumptions per week)
- Smoking
- Non-tasters of bitter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Quinine on Food Intake: Oral Sham Feeding Versus Intragastric Delivery
Rationale: The appearance of tastants in the small intestine following food ingestion results in the onset of digestion and absorption but can also 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. In this study, we aim to investigate the effects of oral sham feeding and intragastric delivery of a bitter tastant (quinine) on ad libitum food intake, satiation, gastrointestinal symptoms, and heart rate variability.
Objective: To investigate the effect of oral sham feeding and intragastric delivery of a bitter tastant on food intake.
Read more
Secondary Objective(s):
- To compare the effect of oral sham feeding and intragastric delivery of a bitter tastant on satiation.
- To assess the effect of oral sham feeding and intragastric delivery of a bitter tastant on gastrointestinal symptoms/complaints.
- To assess the effect of oral sham feeding and intragastric delivery of a bitter tastant on heart rate variability.
- Conditions
- Obesity
- Being tested
- Quinine sham feeding quinine, Gastric quinine, Oral sham feeding placebo, Gastric placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quinine sham feeding quinineDietary supplement
Oral sham feeding with quinine
Gastric quinineDietary supplement
A gastric capsule containing quinine
Oral sham feeding placeboDietary supplement
Oral sham feeding with placebo (tap water)
Gastric placeboDietary supplement
A gastric capsule containing placebo (cellulose)
| Study group | Role | What they receive |
|---|---|---|
| Oral quinine, gastric placebo | Experimental | Oral sham feeding of quinine and a gastric capsule containing placebo (cellulose) Receives: Dietary Supplement: Quinine sham feeding quinine; Dietary Supplement: Gastric placebo |
| Oral placebo, gastric quinine | Experimental | Oral sham feeding of placebo (tap water) and a gastric capsule containing quinine Receives: Dietary Supplement: Gastric quinine; Dietary Supplement: Oral sham feeding placebo |
| Oral quinine, gastric quinine | Experimental | Oral sham feeding of quinine and a gastric capsule containing quinine Receives: Dietary Supplement: Quinine sham feeding quinine; Dietary Supplement: Gastric quinine |
| Oral placebo, gastric placebo | Placebo comparator | Oral sham feeding of placebo (tap water) and a gastric capsule containing placebo (cellulose) Receives: Dietary Supplement: Oral sham feeding placebo; Dietary Supplement: Gastric placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad libitum food intake
Difference in ad libitum meal intake (as measured during ad libitum pasta meal)
Measured: on each test day at T= 50, 50 minutes after ingestion of the capsule and sham-feeding
Secondary outcomes (3)
Satiation/satiety
Difference in satiation/satiety (as measured by VAS 0-100mm). VAS scores for satiety feelings (e.g., satiety, fullness, hunger, prospective feeding, desire to eat, desire to snack) will be measured using Visual Analogue Scales (VAS, 0 to 100 mm) anchored at the low end with the most negative or lowest intensity feelings (e.g., extremely unpleasant, not at all), and with opposing terms at the high end (e.g., extremely pleasant, very high, extreme). Volunteers will be asked to indicate on a line which place on the scale best reflects their feeling at that moment. The scoring forms will be collected immediately so that they cannot be used as a reference for later scorings.
Measured: At T= -20 mins, T= -10 mins, T=0 mins, T= 10 mins, T= 20 mins, T= 30 mins, T= 40 mins, T=50 and T= end, where T= 0 is ingestion of capsule and sham-feeding and T= end is whenever the participant finishes the test meal given at T= 50 mins.
GI-symptoms
Difference in gastro-intestinal symptoms (as measured by VAS 0-100mm). VAS scores for gastrointestinal symptoms (burning, bloating, belching, cramps, colics, warm sensation, sensation of abdominal fullness, nausea, pain and relaxation/tensness) will be measured using Visual Analogue Scales (VAS, 0 to 100 mm) anchored at the low end with the most negative or lowest intensity feelings (e.g., extremely unpleasant, not at all), and with opposing terms at the high end (e.g., extremely pleasant, very high, extreme). Volunteers will be asked to indicate on a line which place on the scale best reflects their feeling at that moment. The scoring forms will be collected immediately so that they cannot be used as a reference for later scorings.
Measured: At T= -20 mins, T= -10 mins, T=0 mins, T= 10 mins, T= 20 mins, T= 30 mins, T= 40 mins, T=50 and T= end, where T= 0 is ingestion of capsule and sham-feeding and T= end is whenever the participant finishes the test meal given at T= 50 mins.
Heart rate variability
Difference in heartrate variability
Measured: At T= -150 mins, T= -15 mins, T= 5 mins, and T= 35 mins, where T= -150 is 150 minutes before ingestion of standardized breakfast meal, T= 0 mins is ingestion of capsule and sham-feeding.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start17 Aug 2018
- Primary completion15 Aug 2019
- Study completion15 Aug 2019
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565133
- Sponsor's protocol ID
- METC183012
- Status last verified
- Nov 2019
- First submitted
- 1 May 2018
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Quinine on Food Intake: Oral Sham Feeding Versus Intragastric Delivery
- ClinicalTrials.gov ID
- NCT03565133
- Acronym / sponsor ID
- METC183012
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 17 Aug 2018 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 21 Jun 2018 (actual)
- 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 following food ingestion results in the onset of digestion and absorption but can also 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. In this study, we aim to investigate the effects of oral sham feeding and intragastric delivery of a bitter tastant (quinine) on ad libitum food intake, satiation, gastrointestinal symptoms, and heart rate variability.
Objective: To investigate the effect of oral sham feeding and intragastric delivery of a bitter tastant on food intake.
Secondary Objective(s):
- To compare the effect of oral sham feeding and intragastric delivery of a bitter tastant on satiation.
- To assess the effect of oral sham feeding and intragastric delivery of a bitter tastant on gastrointestinal symptoms/complaints.
- To assess the effect of oral sham feeding and intragastric delivery of a bitter tastant on heart rate variability.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oral quinine, gastric placebo | Experimental | Dietary Supplement: Quinine sham feeding quinine, Dietary Supplement: Gastric placeboOral sham feeding of quinine and a gastric capsule containing placebo (cellulose) |
| Oral placebo, gastric quinine | Experimental | Dietary Supplement: Gastric quinine, Dietary Supplement: Oral sham feeding placeboOral sham feeding of placebo (tap water) and a gastric capsule containing quinine |
| Oral quinine, gastric quinine | Experimental | Dietary Supplement: Quinine sham feeding quinine, Dietary Supplement: Gastric quinineOral sham feeding of quinine and a gastric capsule containing quinine |
| Oral placebo, gastric placebo | Placebo comparator | Dietary Supplement: Oral sham feeding placebo, Dietary Supplement: Gastric placeboOral sham feeding of placebo (tap water) and a gastric capsule containing placebo (cellulose) |
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 and/or gastrointestinal disorders can be defined.
- Age ≥18 and ≤65 years. This study will include healthy adult subjects (male and female).
- BMI ≥18 and ≤25 kg/m2
- Body weight stable over at least the last 6 months (≤ 5% weight change allowed)
Key exclusion criteria (10 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 that can influence study end-points (to be discussed by medical doctor and principal investigator), including vitamin supplementation, 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 and hysterectomy allowed, and other surgery upon judgement of medical doctor and 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 |
|---|---|---|
| Quinine sham feeding quinineOral sham feeding with quinine | Dietary supplement | Oral quinine, gastric placebo, Oral quinine, gastric quinine |
| Gastric quinineA gastric capsule containing quinine | Dietary supplement | Oral placebo, gastric quinine, Oral quinine, gastric quinine |
| Oral sham feeding placeboOral sham feeding with placebo (tap water) | Dietary supplement | Oral placebo, gastric placebo, Oral placebo, gastric quinine |
| Gastric placeboA gastric capsule containing placebo (cellulose) | Dietary supplement | Oral placebo, gastric placebo, Oral quinine, gastric placebo |
Primary outcome
Ad libitum food intake
Time frame: on each test day at T= 50, 50 minutes after ingestion of the capsule and sham-feeding
Difference in ad libitum meal intake (as measured during ad libitum pasta meal)
3 secondary outcomes
Satiation/satiety
Time frame: At T= -20 mins, T= -10 mins, T=0 mins, T= 10 mins, T= 20 mins, T= 30 mins, T= 40 mins, T=50 and T= end, where T= 0 is ingestion of capsule and sham-feeding and T= end is whenever the participant finishes the test meal given at T= 50 mins.
GI-symptoms
Time frame: At T= -20 mins, T= -10 mins, T=0 mins, T= 10 mins, T= 20 mins, T= 30 mins, T= 40 mins, T=50 and T= end, where T= 0 is ingestion of capsule and sham-feeding and T= end is whenever the participant finishes the test meal given at T= 50 mins.
Heart rate variability
Time frame: At T= -150 mins, T= -15 mins, T= 5 mins, and T= 35 mins, where T= -150 is 150 minutes before ingestion of standardized breakfast meal, T= 0 mins is ingestion of capsule and sham-feeding.
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 Nov 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric quinine 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 10 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 Nov 2019. 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 food intake (time frame: on each test day at T= 50, 50 minutes after ingestion of the capsule and sham-feeding). 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 Nov 2019.