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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00259246
First Posted: November 29, 2005
Last Update Posted: January 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
EC-FP6 (contract number: LHM-CT-2003-503041)
Aditech Pharma AB
Information provided by:
University of Copenhagen
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
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

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00259246     History of Changes
Other Study ID Numbers: B208,1
First Submitted: November 25, 2005
First Posted: November 29, 2005
Last Update Posted: January 21, 2009
Last Verified: April 2005