Physiology - Regulation of Appetite and Food Intake
Conditions
Keywords
food intake, appetite, obesity treatment, neurotensin, gastrointestinal, peptide
Brief 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. This study investigates whether the anorexic effects of NT suggested by animal studies can be translated.
Interventions
OTHERNeurotensin
Intravenous infusion of neurotensin
OTHERSaline
Intravenous infusion of saline
OTHERAd libitum meal
Participants will be served a large meal serving. They will be instructed to eat until they do not feel hungry anymore.
OTHERLiquid meal
A standardized mixed liquid meal will be ingested to stimulate endogenous peptide hormone release
Sponsors
Copenhagen University Hospital, Hvidovre
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants will not be informed of the nature of the infusion they are administered on any of the study days. The investigator will be provided with an infusion (either isotonic saline with HSA or isotonic salin with HSA + neurotensin) prepared by a designated colleague
Intervention 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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* age = or above 18 years * normal haemoglobin levels * male * informed consent
Exclusion criteria
* 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 * Smoker * Nephropathy (S-creatinine\> 130 μM) * Liver disease (ALAT and/or ASAT \> 2 × upper normal limit)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ad libitum food intake (ad libitum days) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Appetite and gastrointestinal sensations (liquid meal + ad libitum days) | -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min | Using visual analogue scales (VAS) the effect of infusions and meals will be documented. Ad libitum meals will also be evaluated using VAS. |
| Plasma glucose (ad libitum days) | -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min | Bed-side measurements of plasma glucose |
| Plasma glucose (liquid meal + ad libitum days) | -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 180, 240 min | Bed-side measurements of plasma glucose |
| Neurotensin (ad libitum days) | -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min | Plasma analysis |
| Neurotensin (liquid meal + ad libitum days) | -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 180, 240 min | Plasma analysis |
| Insulin (liquid meal + ad libitum days) | -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min | Serum analysis |
| Bile acids (ad libitum days) | -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min | Plasma analysis |
| bile acids (liquid meal + ad libitum days) | -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min | Plasma analysis |
| Ghrelin (ad libitum days) | -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min | Plasma analysis |
| Glucagon-like peptide-1 (GLP-1) (ad libitum days) | -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min | Plasma analysis |
| Glucagon-like peptide-1 (GLP-1) (liquid meal + ad libitum days) | -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min | Plasma analysis |
| Glucose-dependent insulinotropic polypeptide (GIP) (liquid meal + ad libitum days) | -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min | Plasma analysis |
| Peptide YY (PYY) (liquid meal + ad libitum days) | -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min | Plasma analysis |
| Paracetamol (liquid meal + ad libitum days) | -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min | Serum analyses |
| Pancreatic polypeptide (PP) (liquid meal + ad libitum days) | -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min | Plasma analysis |
| Pancreatic polypeptide (PP) (ad libitum days) | -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min | Plasma analysis |
| Cholecystokinin (CCK) (ad libitum days) | -60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min | Plasma analysis |
| Cholecystokinin (CCK) (liquid meal + ad libitum days) | -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min | Plasma analysis |
| Ghrelin (liquid meal + ad libitum days) | -60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min | Plasma analysis |
| Appetite and gastrointestinal sensations (ad libitum days) | -60, -15, 15, 30, 60, 90, 120 min | Using visual analogue scales (VAS) the effect of infusions and meals will be documented. Ad libitum meals will also be evaluated using VAS. |
Countries
Denmark
Outcome results
None listed