Effect of Protein From Animal and Vegetable Sources on Appetite

Focus of Study: Appetite Clinical Trial

— PAVA  

Official title:

Effect of Protein From Animal and Vegetable Sources on Appetite

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01345487
• Other study ID #: B275
• Status: Completed
• Phase: N/A
• First received: April 27, 2011
• Last updated: March 24, 2015
• Start date: April 2011
• Est. completion date: July 2011

Study information

• Verified date: March 2015
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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%)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Focus of Study: Appetite

Intervention

Other:
• Vegetable Protein
Vegetable protein in the form of fava beans/split peas
• Animal protein
Protein in the form of minced pork/beef

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen	Frederiksberg C

Sponsors (1)

Lead Sponsor	Collaborator
Arne Astrup

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Secondary	Appetite ratings	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	No