NCT01345487

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 2, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 2015

Enrollment Period

2 months

First QC Date

April 27, 2011

Last Update Submit

March 24, 2015

Conditions

Keywords

appetiteproteinlegumesmeat

Outcome Measures

Primary Outcomes (2)

  • Composite appetite score area under the curve (180 min)

    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

    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 Outcomes (1)

  • Appetite ratings

    Assessed every 30 min for 180 min after each or the 3 test meals which are served 1 wk apart

Study Arms (3)

Low Vegetable Protein

OTHER

Meal with 10 E% protein from fava beans/split peas

Other: Vegetable Protein

High Vegetable protein

EXPERIMENTAL

Meal with 20 E% protein from fava beans/split peas

Other: Vegetable Protein

High Animal Protein

EXPERIMENTAL

Meal with 20 E% protein from pork/beef

Other: Animal protein

Interventions

Vegetable protein in the form of fava beans/split peas

High Vegetable proteinLow Vegetable Protein

Protein in the form of minced pork/beef

High Animal Protein

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen

Frederiksberg C, 1958, Denmark

Location

MeSH Terms

Interventions

Plant Proteins, Dietary

Intervention Hierarchy (Ancestors)

Dietary ProteinsProteinsAmino Acids, Peptides, and ProteinsPlant ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Arne Astrup, Professor

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

April 27, 2011

First Posted

May 2, 2011

Study Start

April 1, 2011

Primary Completion

June 1, 2011

Study Completion

July 1, 2011

Last Updated

March 25, 2015

Record last verified: 2015-03

Locations