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

NCT01616251 | Completed

• 1 other identifier: B294
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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:
• Subjective appetite (VAS) (every 30 min for 3 hours)
• Ad libitum EI (3 hours after lunch test meal)

Conditions

Obesity

Keywords

Protein sources; Appetite; Dietary fibers; Meat; Egg; Legumes

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (5)

• Acute 3-h changes from baseline in subjective appetite sensations using visual analogue scales

  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

• Rating of the organoleptic quality of the test meals

  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

• Rating of the organoleptic quality of the ad libitum meal

  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

• Subjective appetite sensations (visual analogue scales) after ad libitum meal

  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)

• 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.

Study Arms (4)

Vegetable protein meal

EXPERIMENTAL

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

Egg protein meal + fibers

EXPERIMENTAL

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

Egg protein meal

EXPERIMENTAL

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

Meat protein meal + fibers

EXPERIMENTAL

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

Interventions

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.

Egg protein meal; Egg protein meal + fibers; Meat protein meal + fibers; Vegetable protein meal

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy
• BMI: 18.5-30.0 kg/m2
• Non-smoking
• Nonathletic (\< 10 h hard physical activity)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

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

Frederiksberg, 1958, Denmark

Location

MeSH Terms

Conditions

Obesity

Interventions

Energy Intake

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Anne B Raben, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Dr Med

Study Record Dates

• First Submitted: June 7, 2012
• First Posted: June 11, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 30, 2016

Record last verified: 2016-06

Locations

DK (1)