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Neurotensin Infusions in Healthy Individuals -

Plain-language guide to NCT04179331: not phased randomized trial of Neurotensin, 9 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04179331
Phase
not phased
Status
completed
Start
2019-03-01
Completion (planned or actual)
2020-01-23
Participants
9 (actual)
Design
randomized, triple-blind, basic_science
Conditions studied
Healthy
Results posted
not yet

What This Study Did, in Plain Language

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 two arms (groups): Neurotensin (experimental) and Saline (experimental).

The registry classes the interventions as other.

Who Took Part

9 actual participants took part.

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

It was run as a randomized, crossover and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Neurotensin and who got the comparison, which limits bias.

Each person switched between Neurotensin and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Neurotensin.

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

It started in 2019-03-01 with completion listed for 2020-01-23.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Food intake (time frame: From time point t=190-220 minutes).

It also tracked 12 secondary outcomes, for example Hunger, Satiation, Fullness, Prospective food intake, Comfort and Thirst.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Neurotensin in 9 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

Neurotensin: A 13-amino-acid peptide found in the brain and gut; studied in a small number of human trials.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.