ObesityPAVA-IINCT01616251
Acute Effect of Animal and Vegetable Protein Rich Meals With Comparable Dietary Fibers Content on Appetite Sensation and Energy Intake
A study testing Acute effect of animal and vegetable protein rich meals with comparable dietary fibers content on appetite sensation and energy intake in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Acute effect of animal and vegetable protein rich meals with comparable dietary fibers content on appetite sensation and energy intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Human Nutrition, Faculty of Science, University of Copenhagen
Frederiksberg, 1958
About this study
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.
Read more
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
- Being tested
- Acute effect of animal and vegetable protein rich meals with comparable dietary fibers content on appetite sensation and energy intake
- Keywords
- Protein sources, Appetite, Dietary fibers, Meat, Egg, Legumes
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute effect of animal and vegetable protein rich meals with comparable dietary fibers content on appetite sensation and energy intakeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Vegetable protein meal | Experimental | Vegetable protein meal based on legumes (3.6 MJ, 19E% protein, 28 g dietary fibers) Receives: 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) Receives: 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) Receives: 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) Receives: Other: Acute effect of animal and vegetable protein rich meals with comparable dietary fibers content on appetite sensation and energy intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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
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: 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
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: 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
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: 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
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: 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: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
- Investigators
- Anne B Raben, PhD, Principal investigator, Department of Human Nutrition, Faculty of Science, University of Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616251
- Sponsor's protocol ID
- B294
- Acronym
- PAVA-II
- Status last verified
- Jun 2016
- First submitted
- 7 Jun 2012
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Animal and Vegetable Protein Rich Meals With Comparable Dietary Fibers Content on Appetite Sensation and Energy Intake
- ClinicalTrials.gov ID
- NCT01616251
- Acronym / sponsor ID
- PAVA-II / B294
- Conditions
- Obesity
- Keywords
- Protein sources, Appetite, Dietary fibers, Meat, Egg, Legumes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vegetable protein meal | Experimental | Other: Acute effect of animal and vegetable protein rich meals with comparable dietary fibers content on appetite sensation and energy intakeVegetable protein meal based on legumes (3.6 MJ, 19E% protein, 28 g dietary fibers) |
| Egg protein meal + fibers | Experimental | Other: Acute effect of animal and vegetable protein rich meals with comparable dietary fibers content on appetite sensation and energy intakeProtein meal based on eggs and added pea dietary fibers (3.6 MJ, 19E% protein, 28 g dietary fibers) |
| Egg protein meal | Experimental | Other: Acute effect of animal and vegetable protein rich meals with comparable dietary fibers content on appetite sensation and energy intakeProtein meal based on egg without added dietary fibers (3.6 MJ, 19E% protein, 6 g dietary fibers) |
| Meat protein meal + fibers | Experimental | Other: Acute effect of animal and vegetable protein rich meals with comparable dietary fibers content on appetite sensation and energy intakeProtein meal based on meat and added pea dietary fibers (3.6 MJ, 19E% protein, 29 g dietary fibers) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute effect of animal and vegetable protein rich meals with comparable dietary fibers content on appetite sensation and energy intake4-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. | Other | Egg protein meal, Egg protein meal + fibers, Meat protein meal + fibers, Vegetable protein meal |
Primary outcome
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.
5 secondary outcomes
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
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
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
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)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne B Raben, PhD principal investigator
Department of Human Nutrition, Faculty of Science, University of Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute effect of animal and vegetable protein rich meals with comparable dietary fibers content on appetite sensation and energy intake in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2016.