Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Acute Effect of Animal and Vegetable Protein Rich Meals With Comparable Dietary Fibers Content on Appetite Sensation and Energy Intake (PAVA-II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01616251
First received: June 7, 2012
Last updated: June 29, 2016
Last verified: June 2016
  Purpose

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)

Condition Intervention
Obesity
Other: Acute effect of animal and vegetable protein rich meals with comparable dietary fibers content on appetite sensation and energy intake

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Acute Effect of Animal and Vegetable Protein Rich Meals With Comparable Dietary Fibers Content on Appetite Sensation and Energy Intake

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Ad libitum energy intake [ Time Frame: 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. ] [ Designated as safety issue: No ]
    180 min after each test meal an ad libitum meal of spaghetti bolognese is served, and the total energy intake is recorded.


Secondary Outcome Measures:
  • Acute 3-h changes from baseline in subjective appetite sensations using visual analogue scales [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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.

  • Rating of the organoleptic quality of the test meals [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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.

  • Rating of the organoleptic quality of the ad libitum meal [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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.

  • Subjective appetite sensations (visual analogue scales) after ad libitum meal [ Time Frame: 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) ] [ Designated as safety issue: No ]
    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.

  • Compensatory food intake (weighed dietary food record) [ Time Frame: 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. ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: August 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vegetable protein meal
Vegetable protein meal based on legumes (3.6 MJ, 19E% protein, 28 g dietary fibers)
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.
Experimental: Egg protein meal + fibers
Protein meal based on eggs and added pea dietary fibers (3.6 MJ, 19E% protein, 28 g dietary fibers)
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.
Experimental: Egg protein meal
Protein meal based on egg without added dietary fibers (3.6 MJ, 19E% protein, 6 g dietary fibers)
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.
Experimental: Meat protein meal + fibers
Protein meal based on meat and added pea dietary fibers (3.6 MJ, 19E% protein, 29 g dietary fibers)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616251

Locations
Denmark
Department of Human Nutrition, Faculty of Science, University of Copenhagen
Frederiksberg, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Investigators
Principal Investigator: Anne B Raben, PhD Department of Human Nutrition, Faculty of Science, University of Copenhagen, Denmark
  More Information

Responsible Party: Arne Astrup, Professor, Dr Med, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01616251     History of Changes
Other Study ID Numbers: B294 
Study First Received: June 7, 2012
Last Updated: June 29, 2016
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Copenhagen:
Protein sources
Appetite
Dietary fibers
Meat
Egg
Legumes

ClinicalTrials.gov processed this record on September 26, 2016