Endocrine System DiseasesNCT02823249
Effect of Amino Acids and Sugar Alcohols on Satiation Peptides and Activation of Specific Brain Regions
A study testing 1.56 g L-Tryptophan, 1.56 g L-Leucine and 50 g Xylitol in people with Endocrine System Diseases, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
With this study the investigators investigate the effects of amino acids (tryptophan, leucin) and sugar alcohols (xylitol, erythritol) on satiety mechanisms and brain activation. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Endocrine System Diseases
- What is being tested?
- 1.56 g L-Tryptophan, 1.56 g L-Leucine and 50 g Xylitol
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2014to Apr 2015
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy normal weight subjects with a body-mass index of 19.0-24.9
- Healthy obese subjects with a body-mass index of > 30
- Normal eating habits (no diets; no dietary changes; no special dietary habits such as vegetarian/vegan)
- Age 18-40 years
- Stable body weight for at least three months
Who cannot join
- Smoking
- Substance abuse
- Regular intake of medications (except for oral contraceptives)
- Medical or psychiatric illness
- History of gastrointestinal disorders
- Food allergies
Show all 10Show fewer
- Pregnancy, breast feeding
- Body piercings that cannot be removed
- History of claustrophobia
- Left-hander
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Effect of Amino Acids and Sugar Alcohols on Release of Satiation Peptides and Activation of Specific Brain Regions in Normal Weight and Obese Subjects
With this study the investigators investigate the effects of amino acids (tryptophan, leucin) and sugar alcohols (xylitol, erythritol) on satiety mechanisms and brain activation.
- Conditions
- Endocrine System Diseases
- Being tested
- 1.56 g L-Tryptophan, 1.56 g L-Leucine, 50 g Xylitol, 75 g Erythritol, 75 g Glucose
- Medical subject headings
- Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.56 g L-TryptophanDietary supplement
1.56 g L-LeucineDietary supplement
50 g XylitolDietary supplement
75 g ErythritolDietary supplement
75 g GlucoseDietary supplement
Tap waterDietary supplement
Mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate)Dietary supplement
Nasogastric TubeDevice
| Study group | Role | What they receive |
|---|---|---|
| 1.56 g L-Tryptophan | Active comparator | 1.56 g L-Tryptophan in 300 mL tap water given via nasogastric tube
+ after 60 min: 500ml of a mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate) given via nasogastric tube Receives: Dietary Supplement: 1.56 g L-Tryptophan; Dietary Supplement: Tap water; Dietary Supplement: Mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate); Device: Nasogastric Tube |
| 1.56 g L-Leucine | Active comparator | 1.56 g L-Leucine in 300 mL tap water given via nasogastric tube
+ after 60 min: 500ml of a mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate) given via nasogastric tube Receives: Dietary Supplement: 1.56 g L-Leucine; Dietary Supplement: Tap water; Dietary Supplement: Mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate); Device: Nasogastric Tube |
| 50 g Xylitol | Active comparator | 50 g Xylitol in 300 mL tap water given via nasogastric tube Receives: Dietary Supplement: 50 g Xylitol; Dietary Supplement: Tap water; Device: Nasogastric Tube |
| 75 g Erythritol | Active comparator | 75 g Erythritol in 300 mL tap water given via nasogastric tube Receives: Dietary Supplement: 75 g Erythritol; Dietary Supplement: Tap water; Device: Nasogastric Tube |
| 75 g Glucose and mixed liquid meal | Placebo comparator | 75 g Glucose in 300 mL tap water given via nasogastric tube
+ after 60 min: 500ml of a mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate) given via nasogastric tube Receives: Dietary Supplement: 75 g Glucose; Dietary Supplement: Tap water; Dietary Supplement: Mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate); Device: Nasogastric Tube |
| Tap water and mixed liquid meal | Placebo comparator | 300 mL tap water given via nasogastric tube
+ after 60 min: 500ml of a mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate) given via nasogastric tube Receives: Dietary Supplement: Tap water; Dietary Supplement: Mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate); Device: Nasogastric Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of aminoacids on cerebral blood flow measured by functional brain MRI
Measured: changes from baseline to one hour after treatment
Effect of sugar alcohols on cerebral blood flow measured by functional brain MRI
Measured: changes from baseline to one hour after treatment
Secondary outcomes (6)
Measurement of Plasma Glucose concentrations
Measured: changes from baseline to three hours after treatment
Measurement of Plasma Insulin concentrations
Measured: changes from baseline to three hours after treatment
Measurement of Plasma cholecystokinin concentrations
Measured: changes from baseline to three hours after treatment
Measurement of Plasma Glucagon-like Peptide (GLP-1) concentrations
Measured: changes from baseline to three hours after treatment
Measurement of Plasma PYY concentrations
Measured: changes from baseline to three hours after treatment
Measurement of Plasma ghrelin concentrations
Measured: changes from baseline to three hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startMay 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocrine System DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Beglinger, Prof., Study chair, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823249
- Sponsor's protocol ID
- fMRI Aminoacids
- Status last verified
- Feb 2017
- First submitted
- 27 Jun 2016
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Amino Acids and Sugar Alcohols on Release of Satiation Peptides and Activation of Specific Brain Regions in Normal Weight and Obese Subjects
- ClinicalTrials.gov ID
- NCT02823249
- Acronym / sponsor ID
- fMRI Aminoacids
- Conditions
- Endocrine System Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 6 Jul 2016 (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.
With this study the investigators investigate the effects of amino acids (tryptophan, leucin) and sugar alcohols (xylitol, erythritol) on satiety mechanisms and brain activation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1.56 g L-Tryptophan | Active comparator | Dietary Supplement: 1.56 g L-Tryptophan, Dietary Supplement: Tap water, Dietary Supplement: Mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate), Device: Nasogastric Tube1.56 g L-Tryptophan in 300 mL tap water given via nasogastric tube + after 60 min: 500ml of a mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate) given via nasogastric tube |
| 1.56 g L-Leucine | Active comparator | Dietary Supplement: 1.56 g L-Leucine, Dietary Supplement: Tap water, Dietary Supplement: Mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate), Device: Nasogastric Tube1.56 g L-Leucine in 300 mL tap water given via nasogastric tube + after 60 min: 500ml of a mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate) given via nasogastric tube |
| 50 g Xylitol | Active comparator | Dietary Supplement: 50 g Xylitol, Dietary Supplement: Tap water, Device: Nasogastric Tube50 g Xylitol in 300 mL tap water given via nasogastric tube |
| 75 g Erythritol | Active comparator | Dietary Supplement: 75 g Erythritol, Dietary Supplement: Tap water, Device: Nasogastric Tube75 g Erythritol in 300 mL tap water given via nasogastric tube |
| 75 g Glucose and mixed liquid meal | Placebo comparator | Dietary Supplement: 75 g Glucose, Dietary Supplement: Tap water, Dietary Supplement: Mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate), Device: Nasogastric Tube75 g Glucose in 300 mL tap water given via nasogastric tube + after 60 min: 500ml of a mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate) given via nasogastric tube |
| Tap water and mixed liquid meal | Placebo comparator | Dietary Supplement: Tap water, Dietary Supplement: Mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate), Device: Nasogastric Tube300 mL tap water given via nasogastric tube + after 60 min: 500ml of a mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate) given via nasogastric tube |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy normal weight subjects with a body-mass index of 19.0-24.9
- Healthy obese subjects with a body-mass index of > 30
- Normal eating habits (no diets; no dietary changes; no special dietary habits such as vegetarian/vegan)
- Age 18-40 years
- Stable body weight for at least three months
Key exclusion criteria (10 listed)
- Smoking
- Substance abuse
- Regular intake of medications (except for oral contraceptives)
- Medical or psychiatric illness
- History of gastrointestinal disorders
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 |
|---|---|---|
| 1.56 g L-Tryptophan | Dietary supplement | 1.56 g L-Tryptophan |
| 1.56 g L-Leucine | Dietary supplement | 1.56 g L-Leucine |
| 50 g Xylitol | Dietary supplement | 50 g Xylitol |
| 75 g Erythritol | Dietary supplement | 75 g Erythritol |
| 75 g Glucose | Dietary supplement | 75 g Glucose and mixed liquid meal |
| Tap water | Dietary supplement | 1.56 g L-Leucine, 1.56 g L-Tryptophan, 50 g Xylitol, 75 g Erythritol, 75 g Glucose and mixed liquid meal, Tap water and mixed liquid meal |
| Mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate) | Dietary supplement | 1.56 g L-Leucine, 1.56 g L-Tryptophan, 75 g Glucose and mixed liquid meal, Tap water and mixed liquid meal |
| Nasogastric Tube | Device | 1.56 g L-Leucine, 1.56 g L-Tryptophan, 50 g Xylitol, 75 g Erythritol, 75 g Glucose and mixed liquid meal, Tap water and mixed liquid meal |
Primary outcome
Effect of aminoacids on cerebral blood flow measured by functional brain MRI
Time frame: changes from baseline to one hour after treatment
Effect of sugar alcohols on cerebral blood flow measured by functional brain MRI
Time frame: changes from baseline to one hour after treatment
6 secondary outcomes
Measurement of Plasma Glucose concentrations
Time frame: changes from baseline to three hours after treatment
Measurement of Plasma Insulin concentrations
Time frame: changes from baseline to three hours after treatment
Measurement of Plasma cholecystokinin concentrations
Time frame: changes from baseline to three hours after treatment
Measurement of Plasma Glucagon-like Peptide (GLP-1) concentrations
Time frame: changes from baseline to three hours after treatment
Measurement of Plasma PYY concentrations
Time frame: changes from baseline to three hours after treatment
Measurement of Plasma ghrelin concentrations
Time frame: changes from baseline to three hours after treatment
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 28 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
Christoph Beglinger, Prof. study chair
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1.56 g L-Tryptophan, 1.56 g L-Leucine and 50 g Xylitol in people with Endocrine System Diseases, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 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 28 Feb 2017. 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 Switzerland. 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?
Effect of aminoacids on cerebral blood flow measured by functional brain MRI (time frame: changes from baseline to one hour after treatment). The study lists 2 primary outcomes in all. 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 28 Feb 2017.