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

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ClinicalTrials.gov Identifier: NCT01345487
Recruitment Status : Completed
First Posted : May 2, 2011
Last Update Posted : March 25, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Focus of Study: Appetite Other: Vegetable Protein Other: Animal protein

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%)


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Protein From Animal and Vegetable Sources on Appetite
Study Start Date : April 2011
Primary Completion Date : June 2011
Study Completion Date : July 2011
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Composite appetite score area under the curve (180 min) [ Time Frame: Assessed every 30 min for 180 min after each of the three test meals which are served 1 wk apart ]

    Composite score calculated from 10 cm visual analogue scale ratings:

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


  2. Ad libitum energy intake [ Time Frame: Assessed 180 min after each of the 3 test meals, which are served 1 wk apart ]
    180 min after each test meal an ad libitum meal of spaghetti bolognese is served, and the total energy intake is recorded.


Secondary Outcome Measures :
  1. Appetite ratings [ Time Frame: Assessed every 30 min for 180 min after each or the 3 test meals which are served 1 wk apart ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01345487


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

Responsible Party: Arne Astrup, M.D, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01345487     History of Changes
Other Study ID Numbers: B275
First Posted: May 2, 2011    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015

Keywords provided by Arne Astrup, University of Copenhagen:
appetite
protein
legumes
meat