- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00259233
The Role of Peptide YY (PYY)in Inhibiting Food Intake.
January 20, 2009 updated by: University of Copenhagen
The Effects of Peripheral Administration of Saline, PYY1-36 and PYY3-36 on ad Libitum Energy Intake and Appetite.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
24
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
energy intake
|
appetite
|
Secondary Outcome Measures
Outcome Measure |
---|
Blood pressure
|
Plasma PYY profile
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Arne Astrup, Professor, Department of Human Nutrition, RVAU
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Study Completion
May 1, 2005
Study Registration Dates
First Submitted
November 25, 2005
First Submitted That Met QC Criteria
November 25, 2005
First Posted (Estimate)
November 29, 2005
Study Record Updates
Last Update Posted (Estimate)
January 21, 2009
Last Update Submitted That Met QC Criteria
January 20, 2009
Last Verified
April 1, 2007
More Information
Terms related to this study
Other Study ID Numbers
- B208, 2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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