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The Role of Peptide YY (PYY)Infusions in Inhibiting Food Intake.

Plain-language guide to NCT00259246: not phased randomized trial of Peptide YY, 24 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT00259246
Phase
not phased
Status
completed
Start
2004-06
Completion (planned or actual)
2005-11
Participants
24
Design
randomized, single-blind, treatment
Conditions studied
Obesity
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

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

The aim of the study is to compare fasting and postprandial PYY levels between overweight/obese and lean subjects during and after an infusion of saline, PYY1-36 or PYY3-36 and to evaluate the efects on appetite, energy intake and energy expenditure.

The registry classes the interventions as drug.

More on the Plan

The study is a randomised dobbelblinded placebo controlled study with 24 male subjects ( 12 lean and 12 overweight/obese subjects).

VAS scores are used to assess appetite and two ad libitum meals are served in the hours following the infusion.

Energy expenditure is measured by ventilated hood system and blood is sampled during part of the study day.

Who Took Part

Enrollment: 24 planned participants were the target.

It was open to men only aged from 20 years up to 50 years.

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

Examples of who could join: Normal weight (BMI: 18-23 kg/m2) or 12 overweight/obese (BMI: 27-40 kg/m2). Body weight fluctuations \< 5 kg over the past 2 months. Blood pressure normal to mildly hypertensive (\<159/99 mm Hg). Non-elite athletes and not planning to change physical activity during the study.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: any physiological or psychological illnesses that could influence the study results; regular use of medicine; smoking defined as \<1 cigarette per day.

How the Study Was Run

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

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

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

Only one side, usually the participants, was kept unaware of whether Peptide YY was given.

It started in 2004-06 with completion listed for 2005-11.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Appetite. Energy intake.

It also tracked 3 secondary outcomes, for example Energy expenditure and substrate oxidation, Blood parameters and Blood pressure and heart rate.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Peptide YY in 24 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 Peptide YY compound page, all human trials.

Our Notes on the Compound

Peptide YY: A 36-amino-acid gut hormone released after eating that is studied for its role in appetite.

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.