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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014