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

This study has been completed.
Sponsor:
Collaborator:
Aditech Pharma AB
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00259233
First received: November 25, 2005
Last updated: January 20, 2009
Last verified: April 2007
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: The Effects of Peripheral Administration of Saline, PYY1-36 and PYY3-36 on ad Libitum Energy Intake and Appetite.

Resource links provided by NLM:


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

No publications provided

ClinicalTrials.gov Identifier: NCT00259233     History of Changes
Other Study ID Numbers: B208, 2
Study First Received: November 25, 2005
Last Updated: January 20, 2009
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014