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

This study has been completed.

Sponsors and Collaborators:	University of Copenhagen Aditech Pharma AB
Information provided by:	University of Copenhagen
ClinicalTrials.gov Identifier:	NCT00259233

Purpose

12 obese subjects will receive peripheral administration of placebo and 4 escalating doses of PYY1-36 and another 12 obese subjects will receive peripheral administration of placebo and 4 escalating doses PYY3-36 on 5 different test days within one week. The patients will be tested in a single blinded dose escalating protocol. Measurements of appetite, ad libitum energy intake, blood pressure and blood sampling will be performed during the test day.

Condition	Intervention
Obesity	Drug: peripheral Peptide YY administration

MedlinePlus related topics: Obesity

Drug Information available for: Sodium chloride Peptide YY

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	The Effects of Peripheral Administration of Saline, PYY1-36 and PYY3-36 on ad Libitum Energy Intake and Appetite.

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:

appetite
energy intake

Secondary Outcome Measures:

Plasma PYY profile
Blood pressure

Estimated Enrollment:	24
Study Start Date:	March 2005
Estimated Study Completion Date:	May 2005

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: NCT00259233

Sponsors and Collaborators

University of Copenhagen

Aditech Pharma AB

Investigators

Principal Investigator:

Arne Astrup, Professor

Department of Human Nutrition, RVAU

More Information

Study ID Numbers:	B208, 2
Study First Received:	November 25, 2005
Last Updated:	April 20, 2007
ClinicalTrials.gov Identifier:	NCT00259233
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
Overweight
Overnutrition

ClinicalTrials.gov processed this record on January 14, 2009