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OpenTrials
Completed

NCT Number: NCT00259246

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peptide YY infusion

Drug

Primary outcomes

  1. Appetite

  2. Energy intake

Secondary outcomes

  1. Energy expenditure and substrate oxidation

  2. Blood parameters

  3. Blood pressure and heart rate

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Aditech Pharma AB
  • EC-FP6 (contract number: LHM-CT-2003-503041)

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2005
First posted
Nov 29, 2005
Registry last updated
Jan 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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