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

This study has been completed.

First Received: November 25, 2005 Last Updated: January 20, 2009 History of Changes

Sponsors and Collaborators:	University of Copenhagen EC-FP6 (contract number: LHM-CT-2003-503041) Aditech Pharma AB
Information provided by:	University of Copenhagen
ClinicalTrials.gov Identifier:	NCT00259246

Purpose

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.

Condition	Intervention
Obesity	Drug: Peptide YY infusion

MedlinePlus related topics: Obesity

Drug Information available for: Peptide YY

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	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

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:

Appetite
Energy intake

Secondary Outcome Measures:

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

Estimated Enrollment:	24
Study Start Date:	June 2004
Estimated Study Completion Date:	November 2005

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.

Eligibility

Ages Eligible for Study:	20 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259246

Sponsors and Collaborators

University of Copenhagen

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

Aditech Pharma AB

Investigators

Principal Investigator:

Arne Astrup, Professor

Department of Human Nutrition, RVAU

More Information

No publications provided

Study ID Numbers:	B208,1
Study First Received:	November 25, 2005
Last Updated:	January 20, 2009
ClinicalTrials.gov Identifier:	NCT00259246 History of Changes
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overnutrition
Overweight

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on May 07, 2009