Healthy
Conditions
Keywords
Appetite regulation, Food intake, Ad libitum, Hormone secretion
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. In this study, after a 1h baseline period, three doses (2.5, 5.0 and 7.5pmol/kg/min) of NT will be administered in sequence each infusion lasting 1h. On a placebo day saline will be infused similarly 1h infusions. During the final infusion (7.5pmol/kg/min) an ad libitum meal will be ingested. During the experiments blood samples will be collected and subjective perceptions recorded using validated visual analogue scales.
Interventions
OTHERNeurotensin
Neurotensin is an endogenous peptide released from the distal small intestine. It will be administered at three doses (2.5, 5.0 and 7.5pmol/kg/min), each for 1h, in sequence.
OTHERSaline
Isotonic saline will serve as a placebo.
Sponsors
Hvidovre University Hospital
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Double blinded. Neither the investigators performing the experiments or the participants know the nature of the intervention on the two study days.
Intervention model description
Acute physiological experiments conducted in healthy individuals in a University Hospital setting.
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 |
|---|---|---|
| Food intake | From time point t=190-220 minutes | The amount of food ingested over 30 minutes will be determined. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satiation | -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes | Visual analogue scale (100mm) |
| Fullness | -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes | Visual analogue scale (100mm) |
| Prospective food intake | -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes | Visual analogue scale (100mm) |
| Comfort | -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes | Visual analogue scale (100mm) |
| Thirst | -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes | Visual analogue scale (100mm) |
| Hunger | -45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes | Visual analogue scale (100mm) |
| Pancreatic polypeptide | -60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes | Plasma concentration (intact and total) |
| Glucagon | -60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes | Plasma concentration |
| insulin and C-peptide | -60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes | Serum concentration |
| Heart rate | -60 to 250 minutes | Pulse rate every 10 min |
| Blood pressure | -60 to 250 minutes | Systolic and diastolic blood pressures (mmHg) every 10 minutes |
| Neurotensin | -60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes | plasma concentration (intact and total) |
Countries
Denmark
Outcome results
None listed