Clinical trial NCT01616251: Acute Effect of Animal and Vegetable Protein Rich Meals With Comparable Dietary Fibers Content on Appetite Sensation and Energy Intake
Official title: Acute Effect of Animal and Vegetable Protein Rich Meals With Comparable Dietary Fibers Content on Appetite Sensation and Energy Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Protein sources
Appetite
Dietary fibers
Meat
Egg
Legumes
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2012-06-11
Enrollment: 33
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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)


Eligibility 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

Primary outcomes:
measure: Ad libitum energy intake
timeFrame: 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.
Secondary outcomes:
measure: Acute 3-h changes from baseline in subjective appetite sensations using visual analogue scales
timeFrame: 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
measure: Rating of the organoleptic quality of the test meals
timeFrame: 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
measure: Rating of the organoleptic quality of the ad libitum meal
timeFrame: 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
measure: Subjective appetite sensations (visual analogue scales) after ad libitum meal
timeFrame: 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)
measure: Compensatory food intake (weighed dietary food record)
timeFrame: 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.
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Human Nutrition, Faculty of Science, University of Copenhagen
Study officials:
affiliation: Department of Human Nutrition, Faculty of Science, University of Copenhagen, Denmark
name: Anne B Raben, PhD
role: PRINCIPAL_INVESTIGATOR
References: