ObesityProteinNCT01561235
Protein Dose-repsonse Effect on GLP-1, PYY and Appetite in Male Subjects
A study testing Dose-reponse effect of protein on appetite and appetite-regulating hormones in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Dietary protein appears to be the most satiating and thermogenic macronutrient. However, how protein exerts its effect on appetite is not fully known. The effect have been suggested to be related to a higher oxidation rate of protein compared to carbohydrate and fat, and also to a greater thermogenic effect causing… 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?
- Dose-reponse effect of protein on appetite and appetite-regulating hormones
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2008to Jul 2008
- 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: 18.5-40 kg/m2,
- Weight stable (within +/- 3 kg) two months prior to study inclusion,
- Non-smoking,
- Nonathletic,
Who cannot join
- BMI > 40 kg/m2,
- Change in smoking status,
- Daily or frequent use of medication,
- 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,
- Blood pressure was above 150/90 mmHg,
- Hemoglobin < 8 mmol/l.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Contribution of Gastrointestinal Appetite Hormones to Protein-induced
Dietary protein appears to be the most satiating and thermogenic macronutrient. However, how protein exerts its effect on appetite is not fully known. The effect have been suggested to be related to a higher oxidation rate of protein compared to carbohydrate and fat, and also to a greater thermogenic effect causing greater increase in core temperature. The involvement of peripheral appetite-regulating hormones has only been sparingly investigated.
The objective is to investigate the satiating effects of meals with varying content of meat-based protein and whether a dose-response effect can be found on appetite-regulating hormones and appetite ratings.
Design: 25 men will participate in the 3-way, randomized, double-blind, crossover study. The test meals is isocaloric with 30E% fat and increasing protein content at the expense of carbohydrate. Test meals are: normal protein content (NP, 14E% protein), medium-high protein content (MHP, 25E%), and high protein content(HP, 50E%). Four-hour subjective appetite ratings and blood samples will be assessed every half-hour. Subsequently, the subjects will served an ad libitum lunch.
Read the detailed description
Dietary protein appears to be the most satiating and thermogenic macronutrient (7-11). However, how protein exerts its effect on appetite is not fully known. The effect have been suggested to be related to a higher oxidation rate of protein compared to carbohydrate and fat (12), and also to a greater thermogenic effect causing greater increase in core temperature (13). The involvement of peripheral appetite-regulating hormones has only been sparingly investigated (14). These studies have only included two preloads of different concentrations of protein. This is not an optimal design for investigating the protein dose-dependent effect as the threshold can have been reached in between the two concentrations. The effect of protein has mainly been investigated on glucagon-like peptide-1 (GLP-1), ghrelin, cholecystokinin (CCK), and generally after intake of protein below 35% of the energy content (35E%) (5;15-18). The relationship between these appetite-regulating hormones and appetite is still elusive due to contradicting results. Only one study has investigated the effect of protein preloads above 50E%. Bowen et al. (19) found that the high protein preloads could decrease the concentration of CCK and the rate of gastric emptying, which have been shown to enhance the satiating effect of food (20-22). Thus there is a need to examine the effect of protein on appetite-regulating hormones in a dose-response manner in order to detect whether there is an interaction between them and if they can be related to changes in subjective sensations of appetite and EI (14). This should be examined by comparing more than two isocaloric meals in which the protein content and one other macronutrient should vary whereas the third macronutrient should be kept fixed.
Thus, the objective of this study is to investigate the mechanisms responsible for the satiating effects of protein in three isocaloric test meals with a protein content of 14, 25 or 50 E% protein. A possible dose-response effect of protein is investigated on a number of appetite-regulating hormones/peptides, together with changes in ad libitum energy intake.
Design: 25 men will participate in the 3-way, randomized, double-blind, crossover study. The test meals is isocaloric with 30E% fat and increasing protein content at the expense of carbohydrate. Test meals are: normal protein content (NP, 14E% protein), medium-high protein content (MHP, 25E%), and high protein content(HP, 50E%). Four-hour subjective appetite ratings and blood samples will be assessed every half-hour. Subsequently, the subjects will served an ad libitum lunch.
- Conditions
- Obesity
- Being tested
- Dose-reponse effect of protein on appetite and appetite-regulating hormones
- Keywords
- Protein, Appetite, Satiety, Energi intake, Appetite regulating hormones, Dose-response
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose-reponse effect of protein on appetite and appetite-regulating hormonesOther
3-arm meal study for investigation of the mechanisms responsible for the satiating effects of protein in three isocaloric test meals with a protein content of 14, 25 or 50 E% protein. A possible 4-h dose-response effect of protein was investigated on a number of appetite-regulating hormones/peptides, together with changes in subjective appetite sensations and sensory desires were evaluated and ad libitum energy intake.
| Study group | Role | What they receive |
|---|---|---|
| Normal Protein | Active comparator | Energy content 3 or 4 MJ/meal, depending on the subject's individual daily energy requirements).
Macronutrient content: Protein: 14 E%, Fat: 30 E% and carbohydrate: 56E%. The fibre content was similar in all three test meals. The test meals were served as pork/rice/mushroom pâtés, flavoured with thyme in order to blind differences in taste. Receives: Other: Dose-reponse effect of protein on appetite and appetite-regulating hormones |
| Medium-high protein | Experimental | Energy content 3 or 4 MJ/meal, depending on the subject's individual daily energy requirements).
Macronutrient content: Protein: 25E%, Fat: 30 E% and carbohydrate: 45E%. The fibre content was similar in all three test meals. The test meals were served as pork/rice/mushroom pâtés, flavoured with thyme in order to blind differences in taste. Receives: Other: Dose-reponse effect of protein on appetite and appetite-regulating hormones |
| High Protein | Experimental | Energy content 3 or 4 MJ/meal, depending on the subject's individual daily energy requirements).
Macronutrient content: Protein: 50 E%, Fat: 30 E% and carbohydrate: 20E%. The fibre content was similar in all three test meals. The test meals were served as pork/rice/mushroom pâtés, flavoured with thyme in order to blind differences in taste. Receives: Other: Dose-reponse effect of protein on appetite and appetite-regulating hormones |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute 4-h changes from baseline in the postprandial concentration of GLP-1
Blood samples were taken prior to the test meal (baseline). After initiation of the test meal blood samples were collected at time 30, 60, 90, 120, 150, 180, 240 minutes.
Blood samples are analyzed for GLP-1. Data are planned to be statistically analyzed as repeated measurements in mixed linear models. Peak and time to peak will also be analyzed.
Measured: Measured on 3 seperate test days in a crossover design. Each test day was seperated by >4 weeks. On each test day GLP-1 was measured prior to the test meal (time 0) and 30, 60, 90, 120, 150, 180, 240 minutes post intake
Secondary outcomes (11)
Acute 4-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 30, 60, 90, 120, 150, 180, 210, 240 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.
Data are planned to be statistically analyzed as repeated measurements in mixed linear models. Peak and time to peak will also be analyzed.
Measured: Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day appetite sensations were measured prior to the test meal (time 0) and 30, 60, 90, 120, 150, 180, 210, 240 minutes post intake.
Acute 4-h changes from baseline in the postprandial concentration of appetite regulating hormones/peptides
Blood samples were taken prior to the test meal (baseline). After initiation of the test meal blood samples were collected at time 30, 60, 90, 120, 150, 180, 240 minutes.
Blood samples are or will be analyzed for glucagon, pancreatic polypeptide (PP), glucose-dependent insulinotropic polypeptide (GIP), peptid YY (PYY), ghrelin, CCK, amylin and apolipoprotein-IV.
Data are planned to be statistically analyzed as repeated measurements in mixed linear models. Peak and time to peak will also be analyzed.
Measured: Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day blood samples were collected prior to the test meal (time 0) and 30, 60, 90, 120, 150, 180, 240 minutes post intake.
Acute 4-h changes from baseline in the postprandial concentration of glucose
Blood samples were taken prior to the test meal (baseline). After initiation of the test meal blood samples were collected at time 15, 30, 45, 60, 90, 120, 150, 180, 240 minutes.
Blood samples was analyzed for glucose.
Data are planned to be statistically analyzed as repeated measurements in mixed linear models. Peak and time to peak will also be analyzed
Measured: Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day blood samples were collected prior to the test meal (time 0) and 15, 30, 45, 60, 90, 120, 150, 180, 240 minutes post intake.
Acute 4-h changes from baseline in the postprandial concentration of insulin
Blood samples were taken prior to the test meal (baseline). After initiation of the test meal blood samples were collected at time 15, 30, 45, 60, 90, 120, 150, 180, 240 minutes.
Blood samples was analyzed for insulin.
Data are planned to be statistically analyzed as repeated measurements in mixed linear models. Peak and time to peak will also be analyzed
Measured: Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day blood samples were collected prior to the test meal (time 0) and 15, 30, 45, 60, 90, 120, 150, 180, 240 minutes post intake.
Acute 4-h changes from baseline in the postprandial concentrations of lipids
Blood samples were taken prior to the test meal (baseline). After initiation of the test meal blood samples were collected at time 30, 60, 90, 120, 150, 180, 240 minutes.
Blood samples were analyzed for triglycerides, free fatty acids (FFA), total cholesterol, HDL-cholesterol.
The concentration of low density lipoprotein (LDL) cholesterol will be estimated as described by Friedwald et al.
Data are planned to be statistically analyzed as repeated measurements in mixed linear models. Peak and time to peak will also be analyzed
Measured: Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day blood samples were collected prior to the test meal (time 0) and 30, 60, 90, 120, 150, 180, 240 minutes post intake.
Acute 4-h changes from baseline in the body temperature
Body temperature measurement were assessed at time 0, 30, 60, 90, 120, 150, 180, 210, 240 minutes post intake.
Temperature was measured in the participants' ears (ThermoScan 6022, Braun GmbH, Kronberg, Germany).
Data are planned to be statistically analyzed as repeated measurements in mixed linear models. Peak and time to peak will also be analyzed
Measured: Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day temperature was measured prior to the test meal (time 0) and 30, 60, 90, 120, 150, 180, 210, 240 minutes post intake.
Rate of gastric emptying (4-h change from baseline in postprandial concentration of paracetamol)
The subjects drank 500 mg paracetamol desolved in 100 ml water together with the test meal.
Blood samples were taken prior to the test meal (baseline). After initiation of the test meal blood samples were collected at time 30, 60, 90, 120, 150, 180, 240 minutes.
Blood samples was analyzed for concentration of paracetamol.
Data are planned to be statistically analyzed as repeated measurements in mixed linear models. Peak and time to peak will also be analyzed.
Measured: Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day blood samples were collected prior to the test meal (time 0) and 30, 60, 90, 120, 150, 180, 240 minutes post intake.
Rating of the organoleptic quality of the test meals
After completion of the meal the subjects rated the organoleptic quality of the meal by visual analogue scales (VAS) in regard to appearance, smell, taste, after-taste, and general palatability of the meal.
Measured: Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day after completion of the test meal (approximately) time 15 minutes post intake) subjects rated the test meals
Rating of the organoleptic quality of the ad libitum meal
After completion of the meal the subjects rated the organoleptic quality of the ad libitum meal by visual analogue scales (VAS) in regard to appearance, smell, taste, after-taste, and general palatability of the meal.
Measured: Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day after completion of the ad libitum meal subjects rated the meal
Subjective appetite sensations (visual analogue scales) after ad libitum meal
After completion of the meal the subjects rated 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 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day after completion of the ad libitum meal subjects rated their subjective sensation of appetite (approximately 4.5-h post intake of the test meal)
ad libitum energy intake (EI)
240 min after each test meal an ad libitum meal was served, and the total energy intake was recorded
Measured: Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. EI was measured 240 min after intake 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 posted22 Mar 2012 (estimated)
- Study startFeb 2008
- Primary completionJul 2008
- Study completionJul 2008
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 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AAstrup, University of Copenhagen
- Investigators
- Arne Astrup, Professor, Dr Med, Principal investigator, Depertment of Human Nutrition, University of Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561235
- Sponsor's protocol ID
- B243
- Acronym
- Protein
- Status last verified
- Jun 2012
- First submitted
- 13 Mar 2012
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Belza A, Ritz C, Sorensen MQ, Holst JJ, Rehfeld JF, Astrup A. Contribution of gastroenteropancreatic appetite hormones to protein-induced satiety. Am J Clin Nutr. 2013 May;97(5):980-9. doi: 10.3945/ajcn.112.047563. Epub 2013 Mar 6.
PubMed 23466396
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contribution of Gastrointestinal Appetite Hormones to Protein-induced
- ClinicalTrials.gov ID
- NCT01561235
- Acronym / sponsor ID
- Protein / B243
- Conditions
- Obesity
- Keywords
- Protein, Appetite, Satiety, Energi intake, Appetite regulating hormones, Dose-response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 22 Mar 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.
Dietary protein appears to be the most satiating and thermogenic macronutrient. However, how protein exerts its effect on appetite is not fully known. The effect have been suggested to be related to a higher oxidation rate of protein compared to carbohydrate and fat, and also to a greater thermogenic effect causing greater increase in core temperature. The involvement of peripheral appetite-regulating hormones has only been sparingly investigated.
The objective is to investigate the satiating effects of meals with varying content of meat-based protein and whether a dose-response effect can be found on appetite-regulating hormones and appetite ratings.
Design: 25 men will participate in the 3-way, randomized, double-blind, crossover study. The test meals is isocaloric with 30E% fat and increasing protein content at the expense of carbohydrate. Test meals are: normal protein content (NP, 14E% protein), medium-high protein content (MHP, 25E%), and high protein content(HP, 50E%). Four-hour subjective appetite ratings and blood samples will be assessed every half-hour. Subsequently, the subjects will served an ad libitum lunch.
Detailed description
Dietary protein appears to be the most satiating and thermogenic macronutrient (7-11). However, how protein exerts its effect on appetite is not fully known. The effect have been suggested to be related to a higher oxidation rate of protein compared to carbohydrate and fat (12), and also to a greater thermogenic effect causing greater increase in core temperature (13). The involvement of peripheral appetite-regulating hormones has only been sparingly investigated (14). These studies have only included two preloads of different concentrations of protein. This is not an optimal design for investigating the protein dose-dependent effect as the threshold can have been reached in between the two concentrations. The effect of protein has mainly been investigated on glucagon-like peptide-1 (GLP-1), ghrelin, cholecystokinin (CCK), and generally after intake of protein below 35% of the energy content (35E%) (5;15-18). The relationship between these appetite-regulating hormones and appetite is still elusive due to contradicting results. Only one study has investigated the effect of protein preloads above 50E%. Bowen et al. (19) found that the high protein preloads could decrease the concentration of CCK and the rate of gastric emptying, which have been shown to enhance the satiating effect of food (20-22). Thus there is a need to examine the effect of protein on appetite-regulating hormones in a dose-response manner in order to detect whether there is an interaction between them and if they can be related to changes in subjective sensations of appetite and EI (14). This should be examined by comparing more than two isocaloric meals in which the protein content and one other macronutrient should vary whereas the third macronutrient should be kept fixed.
Thus, the objective of this study is to investigate the mechanisms responsible for the satiating effects of protein in three isocaloric test meals with a protein content of 14, 25 or 50 E% protein. A possible dose-response effect of protein is investigated on a number of appetite-regulating hormones/peptides, together with changes in ad libitum energy intake.
Design: 25 men will participate in the 3-way, randomized, double-blind, crossover study. The test meals is isocaloric with 30E% fat and increasing protein content at the expense of carbohydrate. Test meals are: normal protein content (NP, 14E% protein), medium-high protein content (MHP, 25E%), and high protein content(HP, 50E%). Four-hour subjective appetite ratings and blood samples will be assessed every half-hour. Subsequently, the subjects will served an ad libitum lunch.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Protein | Active comparator | Other: Dose-reponse effect of protein on appetite and appetite-regulating hormonesEnergy content 3 or 4 MJ/meal, depending on the subject's individual daily energy requirements). Macronutrient content: Protein: 14 E%, Fat: 30 E% and carbohydrate: 56E%. The fibre content was similar in all three test meals. The test meals were served as pork/rice/mushroom pâtés, flavoured with thyme in order to blind differences in taste. |
| Medium-high protein | Experimental | Other: Dose-reponse effect of protein on appetite and appetite-regulating hormonesEnergy content 3 or 4 MJ/meal, depending on the subject's individual daily energy requirements). Macronutrient content: Protein: 25E%, Fat: 30 E% and carbohydrate: 45E%. The fibre content was similar in all three test meals. The test meals were served as pork/rice/mushroom pâtés, flavoured with thyme in order to blind differences in taste. |
| High Protein | Experimental | Other: Dose-reponse effect of protein on appetite and appetite-regulating hormonesEnergy content 3 or 4 MJ/meal, depending on the subject's individual daily energy requirements). Macronutrient content: Protein: 50 E%, Fat: 30 E% and carbohydrate: 20E%. The fibre content was similar in all three test meals. The test meals were served as pork/rice/mushroom pâtés, flavoured with thyme in order to blind differences in taste. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy,
- BMI: 18.5-40 kg/m2,
- Weight stable (within +/- 3 kg) two months prior to study inclusion,
- Non-smoking,
- Nonathletic,
Key exclusion criteria (8 listed)
- BMI > 40 kg/m2,
- Change in smoking status,
- Daily or frequent use of medication,
- 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 |
|---|---|---|
| Dose-reponse effect of protein on appetite and appetite-regulating hormones3-arm meal study for investigation of the mechanisms responsible for the satiating effects of protein in three isocaloric test meals with a protein content of 14, 25 or 50 E% protein. A possible 4-h dose-response effect of protein was investigated on a number of appetite-regulating hormones/peptides, together with changes in subjective appetite sensations and sensory desires were evaluated and ad libitum energy intake. | Other | High Protein, Medium-high protein, Normal Protein |
Primary outcome
Acute 4-h changes from baseline in the postprandial concentration of GLP-1
Time frame: Measured on 3 seperate test days in a crossover design. Each test day was seperated by >4 weeks. On each test day GLP-1 was measured prior to the test meal (time 0) and 30, 60, 90, 120, 150, 180, 240 minutes post intake
Blood samples were taken prior to the test meal (baseline). After initiation of the test meal blood samples were collected at time 30, 60, 90, 120, 150, 180, 240 minutes. Blood samples are analyzed for GLP-1. Data are planned to be statistically analyzed as repeated measurements in mixed linear models. Peak and time to peak will also be analyzed.
11 secondary outcomes
Acute 4-h changes from baseline in subjective appetite sensations using visual analogue scales
Time frame: Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day appetite sensations were measured prior to the test meal (time 0) and 30, 60, 90, 120, 150, 180, 210, 240 minutes post intake.
Acute 4-h changes from baseline in the postprandial concentration of appetite regulating hormones/peptides
Time frame: Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day blood samples were collected prior to the test meal (time 0) and 30, 60, 90, 120, 150, 180, 240 minutes post intake.
Acute 4-h changes from baseline in the postprandial concentration of glucose
Time frame: Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day blood samples were collected prior to the test meal (time 0) and 15, 30, 45, 60, 90, 120, 150, 180, 240 minutes post intake.
Acute 4-h changes from baseline in the postprandial concentration of insulin
Time frame: Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day blood samples were collected prior to the test meal (time 0) and 15, 30, 45, 60, 90, 120, 150, 180, 240 minutes post intake.
Acute 4-h changes from baseline in the postprandial concentrations of lipids
Time frame: Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day blood samples were collected prior to the test meal (time 0) and 30, 60, 90, 120, 150, 180, 240 minutes post intake.
Acute 4-h changes from baseline in the body temperature
Time frame: Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day temperature was measured prior to the test meal (time 0) and 30, 60, 90, 120, 150, 180, 210, 240 minutes post intake.
Rate of gastric emptying (4-h change from baseline in postprandial concentration of paracetamol)
Time frame: Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day blood samples were collected prior to the test meal (time 0) and 30, 60, 90, 120, 150, 180, 240 minutes post intake.
Rating of the organoleptic quality of the test meals
Time frame: Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day after completion of the test meal (approximately) time 15 minutes post intake) subjects rated the test meals
Rating of the organoleptic quality of the ad libitum meal
Time frame: Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day after completion of the ad libitum meal subjects rated the meal
Subjective appetite sensations (visual analogue scales) after ad libitum meal
Time frame: Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. On each test day after completion of the ad libitum meal subjects rated their subjective sensation of appetite (approximately 4.5-h post intake of the test meal)
ad libitum energy intake (EI)
Time frame: Measured on 3 seperate test days in a crossover design. Each test seperated by >4 weeks. EI was measured 240 min after intake 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 21 Jun 2012.
- Derived from this study: PubMed 23466396Belza A, Ritz C, Sorensen MQ, Holst JJ, Rehfeld JF, Astrup A. Contribution of gastroenteropancreatic appetite hormones to protein-induced satiety. Am J Clin Nutr. 2013 May;97(5):980-9. doi: 10.3945/ajcn.112.047563. Epub 2013 Mar 6.
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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, Professor, Dr Med principal investigator
Depertment of Human Nutrition, 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 Dose-reponse effect of protein on appetite and appetite-regulating hormones 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 21 Jun 2012. 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?
Acute 4-h changes from baseline in the postprandial concentration of GLP-1 (time frame: Measured on 3 seperate test days in a crossover design. Each test day was seperated by >4 weeks. On each test day GLP-1 was measured prior to the test meal (time 0) and 30, 60, 90, 120, 150, 180, 240 minutes post intake). 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 NCT01561235, 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 21 Jun 2012.