HungerSEPANCT02477410
Effects of Hydrolysed Porcine Proteins on Muscle Protein Synthesis and Appetite
A study testing Hydrolysed porcine protein from blood, Hydrolysed porcine protein from muscle and Hydrolysed whey protein in people with Hunger and Satiety Response, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The purpose of the study is to obtain a better understanding of how hydrolysed porcine proteins affect the human metabolism, including the effects on muscle protein synthesis, appetite and secretion of gastrointestinal hormones. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hunger, Satiety Response, Protein Synthesis
- What is being tested?
- Hydrolysed porcine protein from blood, Hydrolysed porcine protein from muscle and Hydrolysed whey protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2015to Jul 2016
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young men
- Normal weight (BMI 18.5-25 kg/m2)
- 22-40 years
Who cannot join
- Vegetarians
- Weight change >3kg within 2 months prior to start of the study
- Regular participation in cardio/strength training within 6 months prior to (and during) the study (>1 per wk)
- Use of alcohol >14 drinks/wk
- Drug abuse
- Smoking
Show all 15Show fewer
- Regular consumption of protein supplements
- Use of over-the-counter or prescription medication that influences body weight, appetite or metabolism
- Diabetes Mellitus
- Dyslipidemia
- Diseases, which influence metabolism
- Donation of blood 3 months prior to start of (and during) the study
- Subjects with a hemoglobin value < 8 mol/L (measured at screening)
- Participation in other clinical studies 1 month prior to start of (and during) the study
- Subjects who are unable to give an informed consent.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Exercise and Sports
Frederiksberg, 1958
About this study
The purpose of the study is to obtain a better understanding of how hydrolysed porcine proteins affect the human metabolism, including the effects on muscle protein synthesis, appetite and secretion of gastrointestinal hormones.
It is hypothesised that hydrolysed porcine proteins will stimulate muscle protein synthesis, affect appetite and the secretion of gastrointestinal hormones similar to hydrolysed whey protein.
Read the detailed description
Previous data show that proteins enhance satiety, decrease hunger and decrease energy intake. In addition, amino acids from dietary protein act as building blocks for de novo protein synthesis and consumption of dietary protein therefore stimulates protein synthesis. Proteins from different sources differ in amino acid composition and rate of absorption. Previously, studies on the effects of proteins on especially muscle protein synthesis has focused on milk proteins, whey and casein as animal sources, but other protein sources high in essential and branched-chain amino acids may also have beneficial effects on muscle protein synthesis and appetite. Thus, in this study the effects of two hydrolysed porcine proteins (one from porcine blood and one from porcine muscle) on muscle protein synthesis, appetite and secretion of gastrointestinal hormones will be compared with the effects of hydrolysed whey protein. These porcine proteins have never previously been tested and it is hypothesised that they may induce similar effects as hydrolysed whey protein due to the high contents of essential and branched-chain amino acids.
The study will be conducted as a randomised, 3-way, cross-over study. It consists of three visits separated by at least two weeks. It is expected that 18 normal-weight, young men will complete the study. They will be randomised to the order of the three proteins; hydrolysed porcine protein from blood (HPB), hydrolysed porcine protein from muscle (HPM) and hydrolysed whey protein (HW). At each visit the effects on muscle protein synthesis, appetite and secretion of gastrointestinal hormones will be measured/assessed. Muscle protein synthesis will be measured after consumption of a low (15 g) and a high (30 g) dose of protein and appetite and secretion of gastrointestinal hormones will be measured after the high protein dose (30 g). The effect on muscle protein synthesis will be measured by a flood-primed continuous infusion of labelled (Ring13C6) phenylalanine, muscle biopsies and blood samples. The effects on appetite will be assessed by visual analogue scales, an ad libitum meal and blood samples.
- Conditions
- Hunger, Satiety Response, Protein Synthesis
- Being tested
- Hydrolysed porcine protein from blood, Hydrolysed porcine protein from muscle, Hydrolysed whey protein
- Keywords
- porcine protein, appetite, muscle protein synthesis, gastrointestinal hormones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrolysed porcine protein from bloodDietary supplement
Effects of hydrolysed porcine proteins on muscle protein synthesis and appetite
Hydrolysed porcine protein from muscleDietary supplement
Effects of hydrolysed porcine proteins on muscle protein synthesis and appetite
Hydrolysed whey proteinDietary supplement
Effects of hydrolysed porcine proteins on muscle protein synthesis and appetite
| Study group | Role | What they receive |
|---|---|---|
| Hydrolysed porcine protein from blood | Experimental | Dietary intervention with hydrolysed porcine protein from blood Receives: Dietary Supplement: Hydrolysed porcine protein from blood |
| Hydrolysed porcine protein from muscle | Experimental | Dietary intervention with hydrolysed porcine protein from muscle Receives: Dietary Supplement: Hydrolysed porcine protein from muscle |
| Hydrolysed whey protein | Experimental | Dietary intervention with hydrolysed whey protein Receives: Dietary Supplement: Hydrolysed whey protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Muscle protein synthesis (%FSR)
Measured: 3 biopsies are taken at time 0, 150 min and 310 min at each visit
Change in Muscle protein synthesis (%FSR)
Measured: 13 blood samples are taken over 310 min
Secondary outcomes (3)
Visual analogue scales (10 cm)
Subjective appetite
Measured: Assessed at time 0, 160, 175, 200, 220, 250, 280, 310, 345 min at each of the three test days
Appetite - ad libitum energy intake
At 325 min an ad libitum meal of spaghetti bolognese is served, and the total energy intake is recorded
Measured: Measured once at time 325 min at each of the three test days
Postprandial response in glycemic control, plasma amino acids and appetite regulating hormones
Measured: Blood samples are taken at 0, 150, 180, 200, 220, 250, 280 and 310 min at each of the three test days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HungerStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Svineafgiftsfonden, DC Ingredients, Arla Foods
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
- Investigators
- Arne Astrup, DMSc, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477410
- Sponsor's protocol ID
- H-15003581
- Acronym
- SEPA
- Status last verified
- Jan 2017
- First submitted
- 11 Jun 2015
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hydrolysed Porcine Proteins on Muscle Protein Synthesis and Appetite
- ClinicalTrials.gov ID
- NCT02477410
- Acronym / sponsor ID
- SEPA / H-15003581
- Conditions
- Hunger, Satiety Response, Protein Synthesis
- Keywords
- porcine protein, appetite, muscle protein synthesis, gastrointestinal hormones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Svineafgiftsfonden, DC Ingredients, Arla Foods
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 22 Jun 2015 (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.
The purpose of the study is to obtain a better understanding of how hydrolysed porcine proteins affect the human metabolism, including the effects on muscle protein synthesis, appetite and secretion of gastrointestinal hormones.
It is hypothesised that hydrolysed porcine proteins will stimulate muscle protein synthesis, affect appetite and the secretion of gastrointestinal hormones similar to hydrolysed whey protein.
Detailed description
Previous data show that proteins enhance satiety, decrease hunger and decrease energy intake. In addition, amino acids from dietary protein act as building blocks for de novo protein synthesis and consumption of dietary protein therefore stimulates protein synthesis. Proteins from different sources differ in amino acid composition and rate of absorption. Previously, studies on the effects of proteins on especially muscle protein synthesis has focused on milk proteins, whey and casein as animal sources, but other protein sources high in essential and branched-chain amino acids may also have beneficial effects on muscle protein synthesis and appetite. Thus, in this study the effects of two hydrolysed porcine proteins (one from porcine blood and one from porcine muscle) on muscle protein synthesis, appetite and secretion of gastrointestinal hormones will be compared with the effects of hydrolysed whey protein. These porcine proteins have never previously been tested and it is hypothesised that they may induce similar effects as hydrolysed whey protein due to the high contents of essential and branched-chain amino acids.
The study will be conducted as a randomised, 3-way, cross-over study. It consists of three visits separated by at least two weeks. It is expected that 18 normal-weight, young men will complete the study. They will be randomised to the order of the three proteins; hydrolysed porcine protein from blood (HPB), hydrolysed porcine protein from muscle (HPM) and hydrolysed whey protein (HW). At each visit the effects on muscle protein synthesis, appetite and secretion of gastrointestinal hormones will be measured/assessed. Muscle protein synthesis will be measured after consumption of a low (15 g) and a high (30 g) dose of protein and appetite and secretion of gastrointestinal hormones will be measured after the high protein dose (30 g). The effect on muscle protein synthesis will be measured by a flood-primed continuous infusion of labelled (Ring13C6) phenylalanine, muscle biopsies and blood samples. The effects on appetite will be assessed by visual analogue scales, an ad libitum meal and blood samples.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hydrolysed porcine protein from blood | Experimental | Dietary Supplement: Hydrolysed porcine protein from bloodDietary intervention with hydrolysed porcine protein from blood |
| Hydrolysed porcine protein from muscle | Experimental | Dietary Supplement: Hydrolysed porcine protein from muscleDietary intervention with hydrolysed porcine protein from muscle |
| Hydrolysed whey protein | Experimental | Dietary Supplement: Hydrolysed whey proteinDietary intervention with hydrolysed whey protein |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy young men
- Normal weight (BMI 18.5-25 kg/m2)
- 22-40 years
Key exclusion criteria (15 listed)
- Vegetarians
- Weight change >3kg within 2 months prior to start of the study
- Regular participation in cardio/strength training within 6 months prior to (and during) the study (>1 per wk)
- Use of alcohol >14 drinks/wk
- Drug abuse
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 |
|---|---|---|
| Hydrolysed porcine protein from bloodEffects of hydrolysed porcine proteins on muscle protein synthesis and appetite | Dietary supplement | Hydrolysed porcine protein from blood |
| Hydrolysed porcine protein from muscleEffects of hydrolysed porcine proteins on muscle protein synthesis and appetite | Dietary supplement | Hydrolysed porcine protein from muscle |
| Hydrolysed whey proteinEffects of hydrolysed porcine proteins on muscle protein synthesis and appetite | Dietary supplement | Hydrolysed whey protein |
Primary outcome
Change in Muscle protein synthesis (%FSR)
Time frame: 3 biopsies are taken at time 0, 150 min and 310 min at each visit
Change in Muscle protein synthesis (%FSR)
Time frame: 13 blood samples are taken over 310 min
3 secondary outcomes
Visual analogue scales (10 cm)
Time frame: Assessed at time 0, 160, 175, 200, 220, 250, 280, 310, 345 min at each of the three test days
Appetite - ad libitum energy intake
Time frame: Measured once at time 325 min at each of the three test days
Postprandial response in glycemic control, plasma amino acids and appetite regulating hormones
Time frame: Blood samples are taken at 0, 150, 180, 200, 220, 250, 280 and 310 min at each of the three test days
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 11 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Arne Astrup, DMSc 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 Hydrolysed porcine protein from blood, Hydrolysed porcine protein from muscle and Hydrolysed whey protein in people with Hunger and Satiety Response, 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 3 inclusion and 15 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 11 Jan 2017. 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?
Change in Muscle protein synthesis (%FSR) (time frame: 3 biopsies are taken at time 0, 150 min and 310 min at each visit). 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 11 Jan 2017.