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

This study has been completed.
Sponsor:
Collaborators:
EC-FP6 (contract number: LHM-CT-2003-503041)
Aditech Pharma AB
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00259246
First received: November 25, 2005
Last updated: January 20, 2009
Last verified: April 2005
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
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

Resource links provided by NLM:


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
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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

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

ClinicalTrials.gov processed this record on October 01, 2014