HealthySAPONCT02521805
Enhanced Satiety With Pork Products Containing Dietary Fibre
A study testing Animal protein, Vegetable protein and Dietary fiber (cereal food matrice) in people with Healthy, run by University of Copenhagen at 1 site in Denmark.
Trial summary
A randomized cross-over meal study will investigate the effects of protein quality and a combination of dietary fibre and protein on appetite regulation. The study will use basic measures of ad libitum energy intake and visual-analogue scales of appetite (study A). Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Animal protein, Vegetable protein and Dietary fiber (cereal food matrice)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2015to Dec 2015
- 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 40 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 40 years
- BMI between 18.5 and 25.0 kg/m2
- Pork eaters
Who cannot join
- Any food allergy, dislike or special diet of relevance to the study
- Daily use of prescription medicine or over-the-counter drugs affecting appetite, energy expenditure or protein metabolism
- Irregular eating schedule
- Self-reporting currently dieting or having lost/gained significant amount of weight (±3 kg) in the previous 3 months
- Any known chronic diseases
- Vigorous physical activity more than 10 hours/week
Show all 13Show fewer
- Smoking, smoking cessation within the past 3 months or nicotine use (> 10 cigarettes per day)
- Substance abuse
- Alcohol intake above the recommendations from the Danish Health and Medicines Authority
- Blood donation <3 month before study start and during study period (only relevant for the sub-study)
- 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
A randomized cross-over meal study will investigate the effects of protein quality and a combination of dietary fibre and protein on appetite regulation.
The study will use basic measures of ad libitum energy intake and visual-analogue scales of appetite (study A). A sub-study (study B) will additionally include blood collection from 15 of the 40 participants to investigate biological markers targeted satiety.
The study days will be conducted at least one week apart to eliminate carry over effects. In the sub-study, the study days will be at least two weeks apart due to blood collection.
Read the detailed description
Dietary proteins have shown to be the most satiating macronutrient, however it is not clear whether various types of protein exert the same effect. The latest evidence on animal versus plant proteins show no differences on appetite and ad libitum energy intake, neither on weight loss but well-designed studies that control for macronutrient composition of protein-rich foods are rare and therefore needed.
Dietary fibre have also shown to play a role in appetite regulation, especially viscous dietary fibre have a greater effect on short-term satiety and subsequent energy intake than less viscous dietary fibers. A combination of dietary fibre and protein would therefore be beneficial in formulation of satiety-enhancing foods targeted consumers who want to maintain or loose weight.
Pork is a good source of high-quality protein and essential vitamins and minerals. The fat content of most retail pork cuts lives up to the Nordic Key Hole nutrition label having less than 10 g fat per 100 gram. Pork can therefore be recognized as a lean meat type delivering key nutrients as part of the diet. Processed pork products such as sausages, liver pate and salamis are nutritionally characterized as high-fat products. However, today the meat industry puts a lot of effort into product development of meat products with a healthier nutritional profile.
The investigators have previously shown that the addition of wheat and rye bran to sausages with 10% fat reduced appetite sensations. Also, the satisfying effect of dietary fibers was more pronounced when added to sausages than when added to bread. These findings point towards a potential for using dietary fibre in meat products in order to improve the nutritional profile of the product as well as the satiating effects.
The overall objective is to investigate the effects of protein quality and a combination of dietary fibre and protein on appetite regulation. Dietary protein and fibre will be combined into an animal protein based food (fiber-meat balls), a vegetable protein based food (veggie "meat balls"), a meal (meat balls with fiber bread) and compared to animal protein per se (meat balls). The study will use measures of ad libitum energy intake and visual-analogue scales of appetite in combination with biological markers targeted satiety.
This study will contribute to a substantial increase in the knowledge on macronutrients and their stimulating effects on appetite-regulating hormones. The study will focus on healthy and palatable pork products containing dietary fibre in order to be applicable to the food industry. The current evidence supports the need for satiating-enhancing foods high in protein and dietary fibre. However, macronutrients and their stimulating effects on appetite-regulating hormones have not been adequately investigated in well-controlled studies using real foods. Likewise, there is no clear evidence that animal protein is superior to vegetable protein with regard to their satiating effects on appetite and appetite-regulating hormones.
- Conditions
- Healthy
- Being tested
- Animal protein, Vegetable protein, Dietary fiber (cereal food matrice), Dietary fiber (meat food matrice), Dietary fiber (vegetable food matrice)
- Keywords
- Appetite, Protein, Protein quality, Dietary fibre, Satiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal proteinOther
Vegetable proteinOther
Dietary fiber (cereal food matrice)Other
Dietary fiber (meat food matrice)Other
Dietary fiber (vegetable food matrice)Other
| Study group | Role | What they receive |
|---|---|---|
| PA | Sham comparator | Animal protein and no fiber (control) Receives: Other: Animal protein |
| PAF | Experimental | Animal protein added fiber Receives: Other: Animal protein; Other: Dietary fiber (meat food matrice) |
| PVF | Experimental | Vegetable protein naturally containing dietary fiber Receives: Other: Vegetable protein; Other: Dietary fiber (vegetable food matrice) |
| PAVM | Experimental | Animal protein and dietary fiber in meal Receives: Other: Animal protein; Other: Dietary fiber (cereal food matrice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad libitum energy intake (kJ)
Food intake from ad libitum meal
Measured: Acute (4 hours)
Secondary outcomes (5)
Subjective appetite ratings (100 mm line scale)
Measured: Acute (4 hours)
Appetite regulating hormones (analysis)
Measured: Postprandial concentrations (4 hours)
Glucose (analysis)
Measured: Postprandial concentrations (4 hours)
Plasma amino acids (analysis)
Measured: Postprandial concentrations (4 hours)
Insulin (analysis)
Measured: Postprandial concentrations (4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- None (open label)
- Enrolment
- 42 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
- NCT02521805
- Sponsor's protocol ID
- B316 SAPO 2B
- Acronym
- SAPO
- Status last verified
- Apr 2016
- First submitted
- 9 Jul 2015
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kehlet U, Kofod J, Holst JJ, Ritz C, Aaslyng MD, Raben A. Addition of Rye Bran and Pea Fiber to Pork Meatballs Enhances Subjective Satiety in Healthy Men, but Does Not Change Glycemic or Hormonal Responses: A Randomized Crossover Meal Test Study. J Nutr. 2017 Sep;147(9):1700-1708. doi: 10.3945/jn.117.250332. Epub 2017 Aug 9.
PubMed 28794212
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Satiety With Pork Products Containing Dietary Fibre
- ClinicalTrials.gov ID
- NCT02521805
- Acronym / sponsor ID
- SAPO / B316 SAPO 2B
- Conditions
- Healthy
- Keywords
- Appetite, Protein, Protein quality, Dietary fibre, Satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Danish Meat Research Institute
- Study start
- Aug 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 Aug 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.
A randomized cross-over meal study will investigate the effects of protein quality and a combination of dietary fibre and protein on appetite regulation.
The study will use basic measures of ad libitum energy intake and visual-analogue scales of appetite (study A). A sub-study (study B) will additionally include blood collection from 15 of the 40 participants to investigate biological markers targeted satiety.
The study days will be conducted at least one week apart to eliminate carry over effects. In the sub-study, the study days will be at least two weeks apart due to blood collection.
Detailed description
Dietary proteins have shown to be the most satiating macronutrient, however it is not clear whether various types of protein exert the same effect. The latest evidence on animal versus plant proteins show no differences on appetite and ad libitum energy intake, neither on weight loss but well-designed studies that control for macronutrient composition of protein-rich foods are rare and therefore needed.
Dietary fibre have also shown to play a role in appetite regulation, especially viscous dietary fibre have a greater effect on short-term satiety and subsequent energy intake than less viscous dietary fibers. A combination of dietary fibre and protein would therefore be beneficial in formulation of satiety-enhancing foods targeted consumers who want to maintain or loose weight.
Pork is a good source of high-quality protein and essential vitamins and minerals. The fat content of most retail pork cuts lives up to the Nordic Key Hole nutrition label having less than 10 g fat per 100 gram. Pork can therefore be recognized as a lean meat type delivering key nutrients as part of the diet. Processed pork products such as sausages, liver pate and salamis are nutritionally characterized as high-fat products. However, today the meat industry puts a lot of effort into product development of meat products with a healthier nutritional profile.
The investigators have previously shown that the addition of wheat and rye bran to sausages with 10% fat reduced appetite sensations. Also, the satisfying effect of dietary fibers was more pronounced when added to sausages than when added to bread. These findings point towards a potential for using dietary fibre in meat products in order to improve the nutritional profile of the product as well as the satiating effects.
The overall objective is to investigate the effects of protein quality and a combination of dietary fibre and protein on appetite regulation. Dietary protein and fibre will be combined into an animal protein based food (fiber-meat balls), a vegetable protein based food (veggie "meat balls"), a meal (meat balls with fiber bread) and compared to animal protein per se (meat balls). The study will use measures of ad libitum energy intake and visual-analogue scales of appetite in combination with biological markers targeted satiety.
This study will contribute to a substantial increase in the knowledge on macronutrients and their stimulating effects on appetite-regulating hormones. The study will focus on healthy and palatable pork products containing dietary fibre in order to be applicable to the food industry. The current evidence supports the need for satiating-enhancing foods high in protein and dietary fibre. However, macronutrients and their stimulating effects on appetite-regulating hormones have not been adequately investigated in well-controlled studies using real foods. Likewise, there is no clear evidence that animal protein is superior to vegetable protein with regard to their satiating effects on appetite and appetite-regulating hormones.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PA | Sham comparator | Other: Animal proteinAnimal protein and no fiber (control) |
| PAF | Experimental | Other: Animal protein, Other: Dietary fiber (meat food matrice)Animal protein added fiber |
| PVF | Experimental | Other: Vegetable protein, Other: Dietary fiber (vegetable food matrice)Vegetable protein naturally containing dietary fiber |
| PAVM | Experimental | Other: Animal protein, Other: Dietary fiber (cereal food matrice)Animal protein and dietary fiber in meal |
Who may qualify
- Ages
- 18 to 40 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 40 years
- BMI between 18.5 and 25.0 kg/m2
- Pork eaters
Key exclusion criteria (13 listed)
- Any food allergy, dislike or special diet of relevance to the study
- Daily use of prescription medicine or over-the-counter drugs affecting appetite, energy expenditure or protein metabolism
- Irregular eating schedule
- Self-reporting currently dieting or having lost/gained significant amount of weight (±3 kg) in the previous 3 months
- Any known chronic 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 |
|---|---|---|
| Animal protein | Other | PA, PAF, PAVM |
| Vegetable protein | Other | PVF |
| Dietary fiber (cereal food matrice) | Other | PAVM |
| Dietary fiber (meat food matrice) | Other | PAF |
| Dietary fiber (vegetable food matrice) | Other | PVF |
Primary outcome
Ad libitum energy intake (kJ)
Time frame: Acute (4 hours)
Food intake from ad libitum meal
5 secondary outcomes
Subjective appetite ratings (100 mm line scale)
Time frame: Acute (4 hours)
Appetite regulating hormones (analysis)
Time frame: Postprandial concentrations (4 hours)
Glucose (analysis)
Time frame: Postprandial concentrations (4 hours)
Plasma amino acids (analysis)
Time frame: Postprandial concentrations (4 hours)
Insulin (analysis)
Time frame: Postprandial concentrations (4 hours)
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 2 May 2016.
- Derived from this study: PubMed 28794212Kehlet U, Kofod J, Holst JJ, Ritz C, Aaslyng MD, Raben A. Addition of Rye Bran and Pea Fiber to Pork Meatballs Enhances Subjective Satiety in Healthy Men, but Does Not Change Glycemic or Hormonal Responses: A Randomized Crossover Meal Test Study. J Nutr. 2017 Sep;147(9):1700-1708. doi: 10.3945/jn.117.250332. Epub 2017 Aug 9.
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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 Animal protein, Vegetable protein and Dietary fiber (cereal food matrice) in people with Healthy, 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 13 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 2 May 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. Some participants in this study may receive a placebo. 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 (kJ) (time frame: Acute (4 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02521805, which also lists 1 linked publication.
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 2 May 2016.