Endocrine System DiseasesNCT02563847
Effect of Amino Acids and Sugar Alcohols on Gastric Emptying and Release of Satiation Peptides in Humans
A study testing 0.52 g L-Tryptophan, 1.56 g L-Tryptophan and 1.56 g L-Leucine 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 in two different concentrations, leucin) and sugar alcohols (xylitol, erythritol) on satiety mechanisms. 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?
- 0.52 g L-Tryptophan, 1.56 g L-Tryptophan and 1.56 g L-Leucine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2014to Mar 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
- Pregnancy, breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Amino Acids and Sugar Alcohols on Gastric Emptying and Release of Satiation Peptides in Normal Weight and Obese Subjects
With this study the investigators investigate the effects of amino acids (tryptophan in two different concentrations, leucin) and sugar alcohols (xylitol, erythritol) on satiety mechanisms.
- Conditions
- Endocrine System Diseases
- Being tested
- 0.52 g L-Tryptophan, 1.56 g L-Tryptophan, 1.56 g L-Leucine, 50 g Xylitol, 75 g Erythritol
- 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.
0.52 g L-TryptophanDietary supplement
1.56 g L-TryptophanDietary supplement
1.56 g L-LeucineDietary supplement
50 g XylitolDietary supplement
75 g ErythritolDietary supplement
75 g GlucoseDietary supplement
300 mL tap waterDietary supplement
50 mg 13C-sodium acetateOther
| Study group | Role | What they receive |
|---|---|---|
| 0.52 g L-Tryptophan | Active comparator | 0.52 g L-Tryptophan in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube Receives: Dietary Supplement: 0.52 g L-Tryptophan; Other: 50 mg 13C-sodium acetate |
| 1.56 g L-Tryptophan | Active comparator | 1.56 g L-Tryptophan in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube Receives: Dietary Supplement: 1.56 g L-Tryptophan; Other: 50 mg 13C-sodium acetate |
| 1.56 g L-Leucine | Active comparator | 1.56 g L-Leucine in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube Receives: Dietary Supplement: 1.56 g L-Leucine; Other: 50 mg 13C-sodium acetate |
| 50 g Xylitol | Active comparator | 50 g Xylitol in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube Receives: Dietary Supplement: 50 g Xylitol; Other: 50 mg 13C-sodium acetate |
| 75 g Erythritol | Active comparator | 75 g Erythritol in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube Receives: Dietary Supplement: 75 g Erythritol; Other: 50 mg 13C-sodium acetate |
| 75 g Glucose | Placebo comparator | 75 g Glucose in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube Receives: Dietary Supplement: 75 g Glucose; Other: 50 mg 13C-sodium acetate |
| Tap water | Placebo comparator | 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube Receives: Dietary Supplement: 300 mL tap water; Other: 50 mg 13C-sodium acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones
Plasma concentrations of glucose
Measured: changes from baseline to three hours after treatment
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones
Plasma concentrations of insulin are measured
Measured: changes from baseline to three hours after treatment
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones
Plasma concentrations of glucagon are measured
Measured: changes from baseline to three hours after treatment
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones
Plasma concentrations of glucagon-like Peptide (GLP-1) are measured
Measured: changes from baseline to three hours after treatment
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones
Plasma concentrations of PYY are measured
Measured: changes from baseline to three hours after treatment
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones
Plasma concentrations of cholecystokinin are measured
Measured: changes from baseline to three hours after treatment
Secondary outcomes (1)
Effect of different aminoacids and sugar alcohols on gastric emptying
measured by C13 breath test
Measured: changes from baseline to four 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 posted30 Sep 2015 (estimated)
- Study startMay 2014
- Primary completionMar 2015
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 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., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563847
- Sponsor's protocol ID
- EKBB 2014/072
- Status last verified
- Sep 2015
- First submitted
- 26 May 2015
- Last updated
- 30 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Meyer-Gerspach AC, Hafliger S, Meili J, Doody A, Rehfeld JF, Drewe J, Beglinger C, Wolnerhanssen B. Effect of L-Tryptophan and L-Leucine on Gut Hormone Secretion, Appetite Feelings and Gastric Emptying Rates in Lean and Non-Diabetic Obese Participants: A Randomized, Double-Blind, Parallel-Group Trial. PLoS One. 2016 Nov 22;11(11):e0166758. doi: 10.1371/journal.pone.0166758. eCollection 2016.
PubMed 27875537
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Amino Acids and Sugar Alcohols on Gastric Emptying and Release of Satiation Peptides in Normal Weight and Obese Subjects
- ClinicalTrials.gov ID
- NCT02563847
- Acronym / sponsor ID
- EKBB 2014/072
- 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
- Mar 2015 (actual)
- First posted
- 30 Sep 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.
With this study the investigators investigate the effects of amino acids (tryptophan in two different concentrations, leucin) and sugar alcohols (xylitol, erythritol) on satiety mechanisms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 0.52 g L-Tryptophan | Active comparator | Dietary Supplement: 0.52 g L-Tryptophan, Other: 50 mg 13C-sodium acetate0.52 g L-Tryptophan in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube |
| 1.56 g L-Tryptophan | Active comparator | Dietary Supplement: 1.56 g L-Tryptophan, Other: 50 mg 13C-sodium acetate1.56 g L-Tryptophan in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube |
| 1.56 g L-Leucine | Active comparator | Dietary Supplement: 1.56 g L-Leucine, Other: 50 mg 13C-sodium acetate1.56 g L-Leucine in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube |
| 50 g Xylitol | Active comparator | Dietary Supplement: 50 g Xylitol, Other: 50 mg 13C-sodium acetate50 g Xylitol in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube |
| 75 g Erythritol | Active comparator | Dietary Supplement: 75 g Erythritol, Other: 50 mg 13C-sodium acetate75 g Erythritol in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube |
| 75 g Glucose | Placebo comparator | Dietary Supplement: 75 g Glucose, Other: 50 mg 13C-sodium acetate75 g Glucose in 300 mL tap water (plus 50 mg 13C-sodium acetate) given via nasogastric tube |
| Tap water | Placebo comparator | Dietary Supplement: 300 mL tap water, Other: 50 mg 13C-sodium acetate300 mL tap water (plus 50 mg 13C-sodium acetate) 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 (7 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 |
|---|---|---|
| 0.52 g L-Tryptophan | Dietary supplement | 0.52 g L-Tryptophan |
| 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 |
| 300 mL tap water | Dietary supplement | Tap water |
| 50 mg 13C-sodium acetate | Other | 0.52 g L-Tryptophan, 1.56 g L-Leucine, 1.56 g L-Tryptophan, 50 g Xylitol, 75 g Erythritol, 75 g Glucose, Tap water |
Primary outcome
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones
Time frame: changes from baseline to three hours after treatment
Plasma concentrations of glucose
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones
Time frame: changes from baseline to three hours after treatment
Plasma concentrations of insulin are measured
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones
Time frame: changes from baseline to three hours after treatment
Plasma concentrations of glucagon are measured
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones
Time frame: changes from baseline to three hours after treatment
Plasma concentrations of glucagon-like Peptide (GLP-1) are measured
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones
Time frame: changes from baseline to three hours after treatment
Plasma concentrations of PYY are measured
Effect of different aminoacids and sugar alcohols on secretion of satiation hormones
Time frame: changes from baseline to three hours after treatment
Plasma concentrations of cholecystokinin are measured
1 secondary outcome
Effect of different aminoacids and sugar alcohols on gastric emptying
Time frame: changes from baseline to four 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 30 Sep 2015.
- Derived from this study: PubMed 27875537Meyer-Gerspach AC, Hafliger S, Meili J, Doody A, Rehfeld JF, Drewe J, Beglinger C, Wolnerhanssen B. Effect of L-Tryptophan and L-Leucine on Gut Hormone Secretion, Appetite Feelings and Gastric Emptying Rates in Lean and Non-Diabetic Obese Participants: A Randomized, Double-Blind, Parallel-Group Trial. PLoS One. 2016 Nov 22;11(11):e0166758. doi: 10.1371/journal.pone.0166758. eCollection 2016.
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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. principal investigator
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 0.52 g L-Tryptophan, 1.56 g L-Tryptophan and 1.56 g L-Leucine 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 7 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 30 Sep 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 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 different aminoacids and sugar alcohols on secretion of satiation hormones (time frame: changes from baseline to three hours after treatment). The study lists 6 primary outcomes in all. 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 NCT02563847, 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 30 Sep 2015; AzTrials last refreshed its copy on 8 Nov 2026.