Physiology - Regulation of Appetite and Food IntakeNIRAHNCT03522792
Neurotensin - an Important Regulator of Appetite in Humans?
A study testing Neurotensin, Saline and Ad libitum meal in people with Physiology - Regulation of Appetite and Food Intake, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Neurotensin (NT) is a gut peptide released postprandially from the small intestine. It is known to exert a range of enterogastrone effects and in animal models it reduces food intake when administered by parenteral routes. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Physiology - Regulation of Appetite and Food Intake
- What is being tested?
- Neurotensin, Saline and Ad libitum meal
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Jan 2018to 1 Dec 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age = or above 18 years
- normal haemoglobin levels
- male
- informed consent
Who cannot join
- Diabetes mellitus (fasting plasma glucose or HbA1c)
- Familiy history of diabetes mellitus
- Intestinal disease (incl e.g. inflammatory bowel disease and malabsorbtion)
- Family history of inflammatory bowel disease
- Previous intestinal resection
- Body mass index (BMI) over 25 kg/m2
Show all 9Show fewer
- Smoker
- Nephropathy (S-creatinine> 130 μM)
- Liver disease (ALAT and/or ASAT > 2 × upper normal limit)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Neurotensin on Appetite, Food Intake, Blood Glucose Regulation, Hormone Secretion, and the Degradation of Neurotensin in Vivo
Neurotensin (NT) is a gut peptide released postprandially from the small intestine. It is known to exert a range of enterogastrone effects and in animal models it reduces food intake when administered by parenteral routes.
This study investigates whether the anorexic effects of NT suggested by animal studies can be translated.
- Being tested
- Neurotensin, Saline, Ad libitum meal, Liquid meal
- Keywords
- food intake, appetite, obesity treatment, neurotensin, gastrointestinal, peptide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurotensinOther
Intravenous infusion of neurotensin
SalineOther
Intravenous infusion of saline
Ad libitum mealOther
Participants will be served a large meal serving. They will be instructed to eat until they do not feel hungry anymore.
Liquid mealOther
A standardized mixed liquid meal will be ingested to stimulate endogenous peptide hormone release
| Study group | Role | What they receive |
|---|---|---|
| Saline + ad libitum meal | Experimental | This will serve as the placebo / control day for the NT + ad libitum meal study day. Receives: Other: Saline; Other: Ad libitum meal |
| NT + ad libitum meal | Experimental | Neurotensin (NT) infusion followed by an ad libitum meal to study the effect of NT on ad libitum food intake. Receives: Other: Neurotensin; Other: Ad libitum meal |
| Saline + liquid meal + ad libitum meal | Experimental | Saline infusion followed a standardized liquid mixed meal followed by an ad libitum meal. This will serve as the placebo / control day for the NT + standardized liquid mixed meal + ad libitum meal study day. Investigating the effect of NT on the second meal effect. Receives: Other: Saline; Other: Ad libitum meal; Other: Liquid meal |
| NT + liquid meal + ad libitum meal | Experimental | NT infusion followed a standardized liquid mixed meal followed by an ad libitum meal. This study day aims to study the effect of NT on the second meal effect. Receives: Other: Neurotensin; Other: Ad libitum meal; Other: Liquid meal |
| Neurotensin | Experimental | Acclimatization day Receives: Other: Neurotensin; Other: Ad libitum meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad libitum food intake (ad libitum days)
Neurotensin (NT) and saline will be infused on two occasions in random order, double blinded. After 1h of infusion an ad libitum meal will be served. When the meal is completed food intake will be determined by weighing the leftovers.
Measured: 60 min
Ad libitum food intake (liquid meal + ad libitum days)
Neurotensin (NT) and saline will be infused on two occasions in random order, double blinded. 1h into the infusions a standardized liquid mixed meal will be ingested. After another 180 min an ad libitum meal will be served. When the meal is completed food intake will be determined by weighing the leftovers.
Measured: 240 min
Secondary outcomes (20)
Appetite and gastrointestinal sensations (ad libitum days)
Using visual analogue scales (VAS) the effect of infusions and meals will be documented.
Ad libitum meals will also be evaluated using VAS.
Measured: -60, -15, 15, 30, 60, 90, 120 min
Appetite and gastrointestinal sensations (liquid meal + ad libitum days)
Using visual analogue scales (VAS) the effect of infusions and meals will be documented.
Ad libitum meals will also be evaluated using VAS.
Measured: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Plasma glucose (ad libitum days)
Bed-side measurements of plasma glucose
Measured: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
Plasma glucose (liquid meal + ad libitum days)
Bed-side measurements of plasma glucose
Measured: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 180, 240 min
Neurotensin (ad libitum days)
Plasma analysis
Measured: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
Neurotensin (liquid meal + ad libitum days)
Plasma analysis
Measured: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 180, 240 min
Insulin (liquid meal + ad libitum days)
Serum analysis
Measured: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Bile acids (ad libitum days)
Plasma analysis
Measured: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
bile acids (liquid meal + ad libitum days)
Plasma analysis
Measured: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Ghrelin (ad libitum days)
Plasma analysis
Measured: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
Ghrelin (liquid meal + ad libitum days)
Plasma analysis
Measured: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Glucagon-like peptide-1 (GLP-1) (ad libitum days)
Plasma analysis
Measured: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
Glucagon-like peptide-1 (GLP-1) (liquid meal + ad libitum days)
Plasma analysis
Measured: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Glucose-dependent insulinotropic polypeptide (GIP) (liquid meal + ad libitum days)
Plasma analysis
Measured: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Peptide YY (PYY) (liquid meal + ad libitum days)
Plasma analysis
Measured: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Paracetamol (liquid meal + ad libitum days)
Serum analyses
Measured: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Pancreatic polypeptide (PP) (liquid meal + ad libitum days)
Plasma analysis
Measured: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Pancreatic polypeptide (PP) (ad libitum days)
Plasma analysis
Measured: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
Cholecystokinin (CCK) (ad libitum days)
Plasma analysis
Measured: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
Cholecystokinin (CCK) (liquid meal + ad libitum days)
Plasma analysis
Measured: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start5 Jan 2018
- Primary completion1 May 2019
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiology - Regulation of Appetite and Food IntakeStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- Model description
- Participants will be studied on multiple occasions (5 days) in a randomised and double blinded fashion. One day will serve as an acclimatization day.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre
- Responsible party
- Principal investigator, Simon Veedfald, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522792
- Sponsor's protocol ID
- Neurotensin BMI/HH 2017 UCPH
- Acronym
- NIRAH
- Status last verified
- Nov 2019
- First submitted
- 14 Dec 2017
- Last updated
- 12 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 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neurotensin on Appetite, Food Intake, Blood Glucose Regulation, Hormone Secretion, and the Degradation of Neurotensin in Vivo
- ClinicalTrials.gov ID
- NCT03522792
- Acronym / sponsor ID
- NIRAH / Neurotensin BMI/HH 2017 UCPH
- Keywords
- food intake, appetite, obesity treatment, neurotensin, gastrointestinal, peptide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 11 May 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.
Neurotensin (NT) is a gut peptide released postprandially from the small intestine. It is known to exert a range of enterogastrone effects and in animal models it reduces food intake when administered by parenteral routes.
This study investigates whether the anorexic effects of NT suggested by animal studies can be translated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Participants will be studied on multiple occasions (5 days) in a randomised and double blinded fashion. One day will serve as an acclimatization day.
| Arm | Type | Receives |
|---|---|---|
| Saline + ad libitum meal | Experimental | Other: Saline, Other: Ad libitum mealThis will serve as the placebo / control day for the NT + ad libitum meal study day. |
| NT + ad libitum meal | Experimental | Other: Neurotensin, Other: Ad libitum mealNeurotensin (NT) infusion followed by an ad libitum meal to study the effect of NT on ad libitum food intake. |
| Saline + liquid meal + ad libitum meal | Experimental | Other: Saline, Other: Ad libitum meal, Other: Liquid mealSaline infusion followed a standardized liquid mixed meal followed by an ad libitum meal. This will serve as the placebo / control day for the NT + standardized liquid mixed meal + ad libitum meal study day. Investigating the effect of NT on the second meal effect. |
| NT + liquid meal + ad libitum meal | Experimental | Other: Neurotensin, Other: Ad libitum meal, Other: Liquid mealNT infusion followed a standardized liquid mixed meal followed by an ad libitum meal. This study day aims to study the effect of NT on the second meal effect. |
| Neurotensin | Experimental | Other: Neurotensin, Other: Ad libitum mealAcclimatization day |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age = or above 18 years
- normal haemoglobin levels
- male
- informed consent
Key exclusion criteria (9 listed)
- Diabetes mellitus (fasting plasma glucose or HbA1c)
- Familiy history of diabetes mellitus
- Intestinal disease (incl e.g. inflammatory bowel disease and malabsorbtion)
- Family history of inflammatory bowel disease
- Previous intestinal resection
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 |
|---|---|---|
| NeurotensinIntravenous infusion of neurotensin | Other | NT + ad libitum meal, NT + liquid meal + ad libitum meal, Neurotensin |
| SalineIntravenous infusion of saline | Other | Saline + ad libitum meal, Saline + liquid meal + ad libitum meal |
| Ad libitum mealParticipants will be served a large meal serving. They will be instructed to eat until they do not feel hungry anymore. | Other | NT + ad libitum meal, NT + liquid meal + ad libitum meal, Neurotensin, Saline + ad libitum meal, Saline + liquid meal + ad libitum meal |
| Liquid mealA standardized mixed liquid meal will be ingested to stimulate endogenous peptide hormone release | Other | NT + liquid meal + ad libitum meal, Saline + liquid meal + ad libitum meal |
Primary outcome
Ad libitum food intake (ad libitum days)
Time frame: 60 min
Neurotensin (NT) and saline will be infused on two occasions in random order, double blinded. After 1h of infusion an ad libitum meal will be served. When the meal is completed food intake will be determined by weighing the leftovers.
Ad libitum food intake (liquid meal + ad libitum days)
Time frame: 240 min
Neurotensin (NT) and saline will be infused on two occasions in random order, double blinded. 1h into the infusions a standardized liquid mixed meal will be ingested. After another 180 min an ad libitum meal will be served. When the meal is completed food intake will be determined by weighing the leftovers.
20 secondary outcomes
Appetite and gastrointestinal sensations (ad libitum days)
Time frame: -60, -15, 15, 30, 60, 90, 120 min
Appetite and gastrointestinal sensations (liquid meal + ad libitum days)
Time frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Plasma glucose (ad libitum days)
Time frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
Plasma glucose (liquid meal + ad libitum days)
Time frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 180, 240 min
Neurotensin (ad libitum days)
Time frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
Neurotensin (liquid meal + ad libitum days)
Time frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 180, 240 min
Insulin (liquid meal + ad libitum days)
Time frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Bile acids (ad libitum days)
Time frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
bile acids (liquid meal + ad libitum days)
Time frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Ghrelin (ad libitum days)
Time frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
Ghrelin (liquid meal + ad libitum days)
Time frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Glucagon-like peptide-1 (GLP-1) (ad libitum days)
Time frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
Glucagon-like peptide-1 (GLP-1) (liquid meal + ad libitum days)
Time frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Glucose-dependent insulinotropic polypeptide (GIP) (liquid meal + ad libitum days)
Time frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Peptide YY (PYY) (liquid meal + ad libitum days)
Time frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Paracetamol (liquid meal + ad libitum days)
Time frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Pancreatic polypeptide (PP) (liquid meal + ad libitum days)
Time frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Pancreatic polypeptide (PP) (ad libitum days)
Time frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
Cholecystokinin (CCK) (ad libitum days)
Time frame: -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min
Cholecystokinin (CCK) (liquid meal + ad libitum days)
Time frame: -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 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 Neurotensin, Saline and Ad libitum meal in people with Physiology - Regulation of Appetite and Food Intake, run by University of Copenhagen at 1 site in Denmark.
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 9 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: status not confirmed, as of the sponsor's last update on 12 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 Denmark. 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. 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?
Results are not available in the source record.
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 (ad libitum days) (time frame: 60 min). 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 12 Nov 2019.