Effect of Protein From Animal and Vegetable Sources on Appetite (PAVA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Copenhagen.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Danish Agriculture and Food Council
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01345487
First received: April 27, 2011
Last updated: May 13, 2011
Last verified: April 2011
  Purpose

New Nordic diet guidelines advocate a reduction in consumption of protein from animal sources such as beef and pork, due to environmental concerns. Instead, intake of protein from vegetable sources such as legumes and pulses should be increased. However, little is known about the effect of protein from (Nordic grown) beans and peas on body weight and appetite regulation.

The objective of this study is to examine if protein from vegetable sources (beans and peas) is comparable to protein from animal sources regarding acute meal-induced satiety.


Condition Intervention
Focus of Study: Appetite
Other: Vegetable Protein
Other: Animal protein

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Protein From Animal and Vegetable Sources on Appetite

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Composite appetite score area under the curve (180 min) [ Time Frame: Assessed every 30 min for 180 min after each test meal ] [ Designated as safety issue: No ]

    Composite score calculated from 10 cm visual analogue scale ratings:

    (desire to eat + hunger + prospective food consumption + (100-fullnes) + (100-satiety))/5



Secondary Outcome Measures:
  • Ad libitum energy intake [ Time Frame: Assessed 180 min after each test meal ] [ Designated as safety issue: No ]
    Ad libitum consumption of spaghetti bolognese

  • Appetite ratings [ Time Frame: Assessed every 30 min for 180 min after each test meal ] [ Designated as safety issue: No ]
    Assessment of hunger, fulness, satiety, desire to eat and prospective food consumption from 10 cm visual analogue scale ratings every 30 min after meal consumption for 3 hours.


Estimated Enrollment: 48
Study Start Date: April 2011
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Low Vegetable Protein
Meal with 10 E% protein from fava beans/split peas
Other: Vegetable Protein
Vegetable protein in the form of fava beans/split peas
Experimental: High Vegetable protein
Meal with 20 E% protein from fava beans/split peas
Other: Vegetable Protein
Vegetable protein in the form of fava beans/split peas
Experimental: High Animal Protein
Meal with 20 E% protein from pork/beef
Other: Animal protein
Protein in the form of minced pork/beef

Detailed Description:

Design:

Single-blind randomized 3-way crossover meal study

Subjects:

  • 48 young healthy men (Age: 18-50 years; BMI: 19-30 kg/m2).
  • Expected completers: n=42.

End points:

  • Subjective appetite (VAS) (every 30 min for 3 hours)
  • Ad libitum energy intake (3 hours after test meal)

Experimental diets:

Iso-caloric breakfast meals (3.5 MJ) with same energy density:

A. Fava beans + Split peas (20 protein E%) B. Fava beans + Split peas + potato (10 protein E%) C. Pork/beef + potato (20 protein E%)

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy men
  • 18-50 y
  • body mass index (BMI) 18.5-30.0

Exclusion Criteria:

  • smoking
  • participation in other studies for 4 mo prior to entry
  • weight gain/loss > 3 kg for to mo prior to entry
  • Strenuous physical activity for > 10 h/wk
  • Use of medication that can affect appetite
  • food allergies or relevance for the test meals
  • Psychiatric or metabolic disorders prohibiting participation
  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: NCT01345487

Contacts
Contact: Nathalie T Bendsen, Post Doc +45 35333633 nathalie@life.ku.dk

Locations
Denmark
Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen Recruiting
Frederiksberg C, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Danish Agriculture and Food Council
Investigators
Principal Investigator: Arne Astrup, Professor University of Copenhagen
  More Information

No publications provided

Responsible Party: Arne Astrup, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01345487     History of Changes
Other Study ID Numbers: B275
Study First Received: April 27, 2011
Last Updated: May 13, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Copenhagen:
appetite
protein
legumes
meat

ClinicalTrials.gov processed this record on October 19, 2014