Focus of Study: AppetitePAVANCT01345487
Effect of Protein From Animal and Vegetable Sources on Appetite
A study testing Vegetable Protein and Animal protein in people with Focus of Study: Appetite, run by Arne Astrup at 1 site in Denmark.
Trial summary
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
- Focus of Study: Appetite
- What is being tested?
- Vegetable Protein and Animal protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2011to Jul 2011
- 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 men
- 18-50 y
- body mass index (BMI) 18.5-30.0
Who cannot join
- smoking
- participation in other studies for 4 mo prior to entry
- weight gain/loss > 3 kg for to mo prior to entry
- Strenuous physical activity for > 10 h/wk
- Use of medication that can affect appetite
- food allergies or relevance for the test meals
- Psychiatric or metabolic disorders prohibiting participation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Frederiksberg C, 1958
About this study
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. However, little is known about the effect of protein from (Nordic grown) beans and peas on body weight and appetite regulation.
The objective of this study is to examine if protein from vegetable sources (beans and peas) is comparable to protein from animal sources regarding acute meal-induced satiety.
Read the detailed description
Design:
Single-blind randomized 3-way crossover meal study
Subjects:
- 48 young healthy men (Age: 18-50 years; BMI: 19-30 kg/m2).
- Expected completers: n=42.
End points:
- Subjective appetite (VAS) (every 30 min for 3 hours)
- Ad libitum energy intake (3 hours after test meal)
Experimental diets:
Iso-caloric breakfast meals (3.5 MJ) with same energy density:
- Fava beans + Split peas (20 protein E%) B. Fava beans + Split peas + potato (10 protein E%) C. Pork/beef + potato (20 protein E%)
- Conditions
- Focus of Study: Appetite
- Being tested
- Vegetable Protein, Animal protein
- Keywords
- appetite, protein, legumes, meat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vegetable ProteinOther
Vegetable protein in the form of fava beans/split peas
Animal proteinOther
Protein in the form of minced pork/beef
| Study group | Role | What they receive |
|---|---|---|
| Low Vegetable Protein | Other | Meal with 10 E% protein from fava beans/split peas Receives: Other: Vegetable Protein |
| High Vegetable protein | Experimental | Meal with 20 E% protein from fava beans/split peas Receives: Other: Vegetable Protein |
| High Animal Protein | Experimental | Meal with 20 E% protein from pork/beef Receives: Other: Animal protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite appetite score area under the curve (180 min)
Composite score calculated from 10 cm visual analogue scale ratings:
(desire to eat + hunger + prospective food consumption + (100-fullnes) + (100-satiety))/5
Measured: Assessed every 30 min for 180 min after each of the three test meals which are served 1 wk apart
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: Assessed 180 min after each of the 3 test meals, which are served 1 wk apart
Secondary outcomes (1)
Appetite ratings
Assessment of hunger, fulness, satiety, desire to eat and prospective food consumption from 10 cm visual analogue scale ratings every 30 min after meal consumption for 3 hours.
Measured: Assessed every 30 min for 180 min after each or the 3 test meals which are served 1 wk apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of Study: AppetiteStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arne Astrup
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Arne Astrup, University of Copenhagen
- Investigators
- Arne Astrup, Professor, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345487
- Sponsor's protocol ID
- B275
- Acronym
- PAVA
- Status last verified
- Mar 2015
- First submitted
- 27 Apr 2011
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Protein From Animal and Vegetable Sources on Appetite
- ClinicalTrials.gov ID
- NCT01345487
- Acronym / sponsor ID
- PAVA / B275
- Conditions
- Focus of Study: Appetite
- Keywords
- appetite, protein, legumes, meat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Arne AstrupUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 2 May 2011 (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.
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. However, little is known about the effect of protein from (Nordic grown) beans and peas on body weight and appetite regulation.
The objective of this study is to examine if protein from vegetable sources (beans and peas) is comparable to protein from animal sources regarding acute meal-induced satiety.
Detailed description
Design:
Single-blind randomized 3-way crossover meal study
Subjects:
- 48 young healthy men (Age: 18-50 years; BMI: 19-30 kg/m2).
- Expected completers: n=42.
End points:
- Subjective appetite (VAS) (every 30 min for 3 hours)
- Ad libitum energy intake (3 hours after test meal)
Experimental diets:
Iso-caloric breakfast meals (3.5 MJ) with same energy density:
- Fava beans + Split peas (20 protein E%) B. Fava beans + Split peas + potato (10 protein E%) C. Pork/beef + potato (20 protein E%)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Vegetable Protein | Other | Other: Vegetable ProteinMeal with 10 E% protein from fava beans/split peas |
| High Vegetable protein | Experimental | Other: Vegetable ProteinMeal with 20 E% protein from fava beans/split peas |
| High Animal Protein | Experimental | Other: Animal proteinMeal with 20 E% protein from pork/beef |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy men
- 18-50 y
- body mass index (BMI) 18.5-30.0
Key exclusion criteria (7 listed)
- smoking
- participation in other studies for 4 mo prior to entry
- weight gain/loss > 3 kg for to mo prior to entry
- Strenuous physical activity for > 10 h/wk
- Use of medication that can affect appetite
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 |
|---|---|---|
| Vegetable ProteinVegetable protein in the form of fava beans/split peas | Other | High Vegetable protein, Low Vegetable Protein |
| Animal proteinProtein in the form of minced pork/beef | Other | High Animal Protein |
Primary outcome
Composite appetite score area under the curve (180 min)
Time frame: Assessed every 30 min for 180 min after each of the three test meals which are served 1 wk apart
Composite score calculated from 10 cm visual analogue scale ratings: (desire to eat + hunger + prospective food consumption + (100-fullnes) + (100-satiety))/5
Ad libitum energy intake
Time frame: Assessed 180 min after each of the 3 test meals, which are served 1 wk apart
180 min after each test meal an ad libitum meal of spaghetti bolognese is served, and the total energy intake is recorded.
1 secondary outcome
Appetite ratings
Time frame: Assessed every 30 min for 180 min after each or the 3 test meals which are served 1 wk apart
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 25 Mar 2015.
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.
Arne Astrup, Professor principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vegetable Protein and Animal protein in people with Focus of Study: Appetite, run by Arne Astrup 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 3 inclusion and 7 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 25 Mar 2015. 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?
Composite appetite score area under the curve (180 min) (time frame: Assessed every 30 min for 180 min after each of the three test meals which are served 1 wk apart). The study lists 2 primary outcomes in all. 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 25 Mar 2015.