- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01345487
Effect of Protein From Animal and Vegetable Sources on Appetite (PAVA)
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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Frederiksberg C, Denmark, 1958
- Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Arne Astrup, Professor, University of Copenhagen
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
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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