Neurotensin - an Important Regulator of Appetite in Humans?

What Was Tested

In this not phased trial, researchers set out to test Neurotensin.

Neurotensin (NT) is a gut peptide released postprandially from the small intestine.

It had five arms (groups): Saline + ad libitum meal (experimental), NT + ad libitum meal (experimental), Saline + liquid meal + ad libitum meal (experimental), NT + liquid meal + ad libitum meal (experimental) and Neurotensin (experimental).

This will serve as the placebo / control day for the NT + ad libitum meal study day.

Neurotensin (NT) infusion followed by an ad libitum meal to study the effect of NT on ad libitum food intake.

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.

The registry classes the interventions as other.

Who Took Part

Enrollment: 18 planned participants were the target.

It was open to men only aged from 18 years up to 50 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age = or above 18 years. Normal haemoglobin levels.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: diabetes mellitus (fasting plasma glucose or hba1c); familiy history of diabetes mellitus; intestinal disease (incl e.g. inflammatory bowel disease and malabsorbtion).

How the Study Was Run

The set-up was randomized, crossover and triple-blind.

Because people in this Neurotensin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Neurotensin and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on Neurotensin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2018-01-05 with completion listed for 2019-05-01.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Ad libitum food intake (ad libitum days) (time frame: 60 min). Ad libitum food intake (liquid meal + ad libitum days) (time frame: 240 min).

It also tracked 20 secondary outcomes, for example Appetite and gastrointestinal sensations (ad libitum days), Appetite and gastrointestinal sensations (liquid meal + ad libitum days), Plasma glucose (ad libitum days), Plasma glucose (liquid meal + ad libitum days), Neurotensin (ad libitum days) and Neurotensin (liquid meal + ad libitum days).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Neurotensin in 18 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Neurotensin compound page, all human trials.