Acute Effect of Animal and Vegetable Protein Rich Meals With Comparable Dietary Fibers Content on Appetite Sensation and Energy Intake

Obesity Clinical Trial

— PAVA-II  

Official title:

Acute Effect of Animal and Vegetable Protein Rich Meals With Comparable Dietary Fibers Content on Appetite Sensation and Energy Intake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01616251
• Other study ID #: B294
• Status: Completed
• Phase: N/A
• First received: June 7, 2012
• Last updated: June 29, 2016
• Start date: August 2012
• Est. completion date: December 2012

Study information

• Verified date: June 2016
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

Background:

• 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.

• A previous study showed that a meal enriched with vegetable protein increased the subjective sensation of satiety and decreased hunger and ad libitum energy intake (EI) compared to animal protein.

• This study did, however, not document that vegetable protein per se is more satiating than animal protein as the vegetable meal had higher fiber content. Fiber is a likely confounder.

• The protein from egg is sparingly investigated in relation to appetite. Few studies have found that eggs have a high satiety index but further investigation is needed.

Objective:

• To examine if vegetable protein (beans and peas) can suppress subjective appetite (VAS and ad libitum energy intake) compared to isocaloric meals enriched with either red meat or egg with similar distribution of macronutrients and content of dietary fibers.

Design:

Single-blind randomized 4-way crossover meal study

Subjects:

33 young healthy men (Age: 18-50 years; BMI: 19-30 kg/m2). Expected completers: n=30.

End points:

1. Subjective appetite (VAS) (every 30 min for 3 hours)

2. Ad libitum EI (3 hours after lunch test meal)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy

• BMI: 18.5-30.0 kg/m2

• Weight stable (within +/- 3 kg) two months prior to study inclusion,

• Non-smoking

• Nonathletic (< 10 h hard physical activity)

Exclusion Criteria:

• BMI > 30 kg/m2

• Change in smoking status

• Daily or frequent use of medication that can affect appetite

• Suffering from metabolic diseases

• Suffering from psychiatric diseases

• Suffering from any other clinical condition, which would make the subject unfit to participate in the study

• alcohol and drug abuse

• food allergies or relevance for the test meals

Study Design

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

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Acute effect of animal and vegetable protein rich meals with comparable dietary fibers content on appetite sensation and energy intake
4-arm crossover study with the objective to examine if vegetable protein (beans and peas) can suppress subjective appetite (VAS and ad libitum EI) compared to isocaloric meals enriched with either red meat or egg with similar distribution of macronutrients and content of dietary fibers.

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition, Faculty of Science, University of Copenhagen	Frederiksberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Measured on 4 separate test days in a crossover design. Each test day is separated by >1 week. Assessed 180 min after each of the 4 test meals.	No
Secondary	Acute 3-h changes from baseline in subjective appetite sensations using visual analogue scales	Assessment of subjective appetite sensations (visual analogue scales (VAS)) at time 0 (baseline - prior to the test meal) and at time 15, 30, 60, 90, 120, 150, 180 minutes post intake. Measured subjective appetite sensations of hunger, satiety, prospective consumption, fullness, composite appetite score and sensory desires to something sweet, salty, rich in fat, or meat/fish.	Measured on 4 separate test days in a crossover design. Each test day is separated by >1 week. On each test day appetite sensations are measured prior to the test meal (time 0) and 15, 30, 60, 90, 120, 150, 180 minutes post intake	No
Secondary	Rating of the organoleptic quality of the test meals	After completion of the test meal the subjects will rate the organoleptic quality of the drink by visual analogue scales (VAS) in regard to appearance, smell, taste, after-taste, and general palatability.	Measured on 4 separate test days in a crossover design. Each test separated by >1 week. On each test day after completion of the test meal subjects will rate the test meal	No
Secondary	Rating of the organoleptic quality of the ad libitum meal	After completion of the adlibitum meal the subjects will rate the organoleptic quality of the meal by visual analogue scales (VAS) in regard to appearance, smell, taste, after-taste, and general palatability.	Measured on 4 separate test days in a crossover design. Each test separated by >1 week. On each test day after completion of the ad libitum meal (approximately) time 15-20 minutes post intake) subjects will rate the ad libitum meal	No
Secondary	Subjective appetite sensations (visual analogue scales) after ad libitum meal	After completion of the ad libitum meal the subjects will rate the subjective appetite sensations by visual analogue scales (VAS) in regard to sensation of hunger, satiety, prospective consumption, fullness, composite appetite score and sensory desires to eat something sweet, salty, rich in fat, or meat/fish.	Measured on 4 separate test days in a crossover design. Each test separated by >1 week. After completion of the ad libitum meal subjects will rate their subjective sensation of appetite (approx 3.5-h post intake of test meal)	No
Secondary	Compensatory food intake (weighed dietary food record)		Measured on 4 separate test days in a crossover design. Each test separated by >1 week. Participants fill in a weighed food record from the time they complete the lunch until midnight.	No