Healthy SubjectsSAPONCT02495870
The Acute Effects of Low Temperature for Long Time Heat Treatment of Pork Semitendinosus on Satiety
A study testing Pork in people with Healthy Subjects, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Cooking meat at low temperatures for prolonged times is widely used among chefs and in food service due to the possibility to obtain a consistent and appealing eating quality. The method is generally termed low-temperature long-time (LTLT) cooking. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Pork
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2014to Dec 2014
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who have provided written informed consent
- Healthy men
- Ages between 18 and 60 years
- BMI between 18.5 and 30 kg/m2
- Pork eaters
Who cannot join
- Any food allergy, dislike or special diet of relevance to the study (e.g. vegetarian)
- Daily use of prescription medicine or over-the-counter drugs affecting appetite, energy expenditure or protein metabolism
- Use of dietary supplements (including protein supplement, powders, shakes) up to 1 month before the first meal test
- Irregular eating schedule (e.g. skipping breakfast)
- Self-reporting currently dieting or having lost/gained significant amount of weight (±3 kg) in the previous 3 months
- Any known chronic diseases (e.g. cancer, heart disease, diabetes, neurological disorders)
Show all 11Show fewer
- Vigorous physical activity more than 10 hours/week
- Smoking, smoking cessation within the past 3 months or nicotine use (electronic cigarettes) (>10 cigarettes per day)
- Participants who work in appetite or feeding related areas
- Participation in other intervention studies
- Participants not able to comply with the study protocol as judged by study personnel
Trial locations and contacts
1 site in 1 country.
About this study
Cooking meat at low temperatures for prolonged times is widely used among chefs and in food service due to the possibility to obtain a consistent and appealing eating quality. The method is generally termed low-temperature long-time (LTLT) cooking. In LTLT cooking, meat is vacuum-packed and heated at temperatures between 50°C and 65°C in a water bath for several hours. LTLT has several benefits - improved tenderness and juiciness, less cooking loss, better vitamin retention and uncompromised food safety.
A recent PhD thesis concluded that one of the mechanisms behind the changes in eating quality during LTLT cooking was due to the proteolytic degradation in the muscle tissue. The activity of proteolytic enzymes has shown to be dependent on heating temperature and time where the cathepsins were found to remain active during heat treatment. At 58°C the cathepsin B+L activity is increased compared to 48°C and 53°C and at 55°C compared to 25°C, 40°C and 70°C. A prolonged heating time of 17 hours at 58°C has also shown to increase cathepsin B+L activity. The proteolytic degradation results in the occurrence of peptides and amino acids such as tryptophan, tyrosine, leucine and histidine which could lead to a faster degree of satiety when consumed.
Read more
According to the aminostatic hypothesis by Mellinkoff, a rise in plasma amino acids elicited by protein ingestion could assist in the suppression of food intake and the onset of satiety.
The investigators therefore hypothesize that the ingestion of LTLT cooked pork would induce a faster satiety response due to the higher availability of peptides and amino acids prior to digestion. An acute meal study will elucidate this. LTLT cooking will be performed by the "cook-chill" method to mimic real life where meat is rapidly chilled after heat treatment, stored at 0-2°C and reheated and browned prior to serving.
- Conditions
- Healthy Subjects
- Being tested
- Pork
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PorkOther
| Study group | Role | What they receive |
|---|---|---|
| Pork, 58°C, 72 minutes | Experimental | Pork muscle (semitendinosus) sous-vide cooked at 58°C for 72 minutes Receives: Other: Pork |
| Pork, 58°C, 17 hours | Experimental | Pork muscle (semitendinosus) sous-vide cooked at 58°C for 17 hours Receives: Other: Pork |
| Meat balls, 58°C, 17 hours | Experimental | Meat balls made from pork Semitendinosus. Sous-vide cooked at 58°C for 17 hours Receives: Other: Pork |
| Pork, 160°C (until 58°C in core) | Active comparator | Pork muscle (semitendinosus) oven cooked at 160°C until 58° in core. Receives: Other: Pork |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad libitum energy intake
the primary outcome is measured 180 min after test meal is consumed
Measured: 180 min
Secondary outcomes (1)
VAS scores for appetite (hunger, satiety, fullness, prospective consumption)
The secondary endpoints are measured every 30 minute after the test meal is consumed
Measured: every 30 min at time points 15, 45, 75, 105, 135, 165, 195 min from termination of the test meal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startNov 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Meat Research Institute
- Responsible party
- Principal investigator, Anne Birgitte Raben, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495870
- Sponsor's protocol ID
- SAPO 2A
- Acronym
- SAPO
- Status last verified
- May 2017
- First submitted
- 10 Nov 2014
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Low Temperature for Long Time Heat Treatment of Pork Semitendinosus on Satiety
- ClinicalTrials.gov ID
- NCT02495870
- Acronym / sponsor ID
- SAPO / SAPO 2A
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Danish Meat Research Institute
- Study start
- Nov 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Jul 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.
Cooking meat at low temperatures for prolonged times is widely used among chefs and in food service due to the possibility to obtain a consistent and appealing eating quality. The method is generally termed low-temperature long-time (LTLT) cooking. In LTLT cooking, meat is vacuum-packed and heated at temperatures between 50°C and 65°C in a water bath for several hours. LTLT has several benefits - improved tenderness and juiciness, less cooking loss, better vitamin retention and uncompromised food safety.
A recent PhD thesis concluded that one of the mechanisms behind the changes in eating quality during LTLT cooking was due to the proteolytic degradation in the muscle tissue. The activity of proteolytic enzymes has shown to be dependent on heating temperature and time where the cathepsins were found to remain active during heat treatment. At 58°C the cathepsin B+L activity is increased compared to 48°C and 53°C and at 55°C compared to 25°C, 40°C and 70°C. A prolonged heating time of 17 hours at 58°C has also shown to increase cathepsin B+L activity. The proteolytic degradation results in the occurrence of peptides and amino acids such as tryptophan, tyrosine, leucine and histidine which could lead to a faster degree of satiety when consumed.
According to the aminostatic hypothesis by Mellinkoff, a rise in plasma amino acids elicited by protein ingestion could assist in the suppression of food intake and the onset of satiety.
The investigators therefore hypothesize that the ingestion of LTLT cooked pork would induce a faster satiety response due to the higher availability of peptides and amino acids prior to digestion. An acute meal study will elucidate this. LTLT cooking will be performed by the "cook-chill" method to mimic real life where meat is rapidly chilled after heat treatment, stored at 0-2°C and reheated and browned prior to serving.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pork, 58°C, 72 minutes | Experimental | Other: PorkPork muscle (semitendinosus) sous-vide cooked at 58°C for 72 minutes |
| Pork, 58°C, 17 hours | Experimental | Other: PorkPork muscle (semitendinosus) sous-vide cooked at 58°C for 17 hours |
| Meat balls, 58°C, 17 hours | Experimental | Other: PorkMeat balls made from pork Semitendinosus. Sous-vide cooked at 58°C for 17 hours |
| Pork, 160°C (until 58°C in core) | Active comparator | Other: PorkPork muscle (semitendinosus) oven cooked at 160°C until 58° in core. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants who have provided written informed consent
- Healthy men
- Ages between 18 and 60 years
- BMI between 18.5 and 30 kg/m2
- Pork eaters
Key exclusion criteria (11 listed)
- Any food allergy, dislike or special diet of relevance to the study (e.g. vegetarian)
- Daily use of prescription medicine or over-the-counter drugs affecting appetite, energy expenditure or protein metabolism
- Use of dietary supplements (including protein supplement, powders, shakes) up to 1 month before the first meal test
- Irregular eating schedule (e.g. skipping breakfast)
- Self-reporting currently dieting or having lost/gained significant amount of weight (±3 kg) in the previous 3 months
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 |
|---|---|---|
| Pork | Other | Meat balls, 58°C, 17 hours, Pork, 160°C (until 58°C in core), Pork, 58°C, 17 hours, Pork, 58°C, 72 minutes |
Primary outcome
Ad libitum energy intake
Time frame: 180 min
the primary outcome is measured 180 min after test meal is consumed
1 secondary outcome
VAS scores for appetite (hunger, satiety, fullness, prospective consumption)
Time frame: every 30 min at time points 15, 45, 75, 105, 135, 165, 195 min from termination of the test meal.
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 8 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pork in people with Healthy Subjects, 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 11 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 8 May 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?
Ad libitum energy intake (time frame: 180 min). 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 8 May 2017.