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Completed

NCT Number: NCT01616251

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

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)

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Human Nutrition, Faculty of Science, University of Copenhagen

Frederiksberg, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acute effect of animal and vegetable protein rich meals with comparable dietary fibers content on appetite sensation and energy intake

Other

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.

Primary outcomes

  1. 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.

    180 min after each test meal an ad libitum meal of spaghetti bolognese is served, and the total energy intake is recorded.

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

  4. 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)

    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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Acronym: PAVA-II

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 11, 2012
Registry last updated
Jun 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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