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

March 24, 2015 updated by: Arne Astrup

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.

Study Overview

Status

Completed

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Frederiksberg C, Denmark, 1958
        • Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Low Vegetable Protein
Meal with 10 E% protein from fava beans/split peas
Vegetable protein in the form of fava beans/split peas
Experimental: High Vegetable protein
Meal with 20 E% protein from fava beans/split peas
Vegetable protein in the form of fava beans/split peas
Experimental: High Animal Protein
Meal with 20 E% protein from pork/beef
Protein in the form of minced pork/beef

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

Assessed every 30 min for 180 min after each of the three test meals which are served 1 wk apart
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.
Assessed 180 min after each of the 3 test meals, which are served 1 wk apart

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed every 30 min for 180 min after each or the 3 test meals which are served 1 wk apart

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Arne Astrup, Professor, University of Copenhagen

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

April 1, 2011

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

April 27, 2011

First Submitted That Met QC Criteria

April 28, 2011

First Posted (Estimate)

May 2, 2011

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • B275

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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