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

January 20, 2009 updated by: University of Copenhagen

Fasting and Postprandial Response After Infusion of Saline, PYY1-36 and PYY3-36 and Effects on Appetite, Energy Intake and Energy Expenditure in Overweight/Obese Compared to Normalweight Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment

24

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Any physiological or psychological illnesses that could influence the study results
  • Regular use of medicine
  • Smoking defined as <1 cigarette per day.
  • Substance abuse or dependence.
  • Blood donation within the past 3 months before entering the study
  • Drinking >21 alcoholic units/week.
  • Food allergies.
  • Special diets (e.g. vegetarian) or dislikes to any of the foods served during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Appetite
Energy intake

Secondary Outcome Measures

Outcome Measure
Energy expenditure and substrate oxidation
Blood parameters
Blood pressure and heart rate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

EC-FP6 (contract number: LHM-CT-2003-503041)
Aditech Pharma AB

Investigators

  • Principal Investigator: Arne Astrup, Professor, Department of Human Nutrition, RVAU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Completion

November 1, 2005

Study Registration Dates

First Submitted

November 25, 2005

First Submitted That Met QC Criteria

November 25, 2005

First Posted (Estimate)

November 29, 2005

Study Record Updates

Last Update Posted (Estimate)

January 21, 2009

Last Update Submitted That Met QC Criteria

January 20, 2009

Last Verified

April 1, 2005

More Information

Terms related to this study

Other Study ID Numbers

  • B208,1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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