Biomarkers of Food Intake in Healthy SubjectsMEPONCT03305718
Biomarkers of Meats and Potatoes Intake.
A study testing Meal sequence: 3C1A2B4D, Meal sequence: 2A3D4C1B and Meal sequence: 2D4B3A1C in people with Biomarkers of Food Intake in Healthy Subjects, run by University of Copenhagen.
Trial summary
The discovery of biomarkers for the intake of meats and potatoes is needed for an accurate assessment of the intake of these foods. Twelve healthy subjects were enrolled in a controlled, cross-over meal study, randomized by a Latin square design. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Biomarkers of Food Intake in Healthy Subjects
- What is being tested?
- Meal sequence: 3C1A2B4D, Meal sequence: 2A3D4C1B and Meal sequence: 2D4B3A1C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2015to 30 May 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI < 30 kg/m2
- Eating and tolerating meat, egg, pea, rice, and potatoes
- No current chronic or infectious disease
- No medication (oral contraceptive pill and mild antidepressants is allowed)
- No dietary supplements
- Did not use antibiotics in the 6 previous months
Who cannot join
- Any condition that makes the project responsible researcher to doubt the feasibility of the volunteer's participation
- Pregnant or lactating women
- Smoking (12 months of non-smoking is allowed)
- Vegan or vegetarian
- Have or have had a drug addiction
- Blood donations within three months before participating in the current trial or participation in other scientific experiments
- Alcohol consumption higher than the Danish Health Authority recommendation of 7 or 14 drinks/week for women and men, respectively.
About this study
Official title: Biomarkers of Meats and Potatoes Intake: a Meal Study in Healthy Men and Women - the MEPO Study.
The discovery of biomarkers for the intake of meats and potatoes is needed for an accurate assessment of the intake of these foods. Twelve healthy subjects were enrolled in a controlled, cross-over meal study, randomized by a Latin square design. The test meals contained 1) beef, pork, chicken and a control meal for the meats and 2) french fries, boiled potatoes, chips and a control for the potato meals. A standardized diet was provided during sample collection. Blood and urine samples were collected up to 48h primarily for untargeted metabolomic profiling. Blood was further collected to study the effect of the meals on insulin and glycemic responses. Effects on satiety were measured by VAS and an ad libitum lunch following the test meals.
Read the detailed description
Protein-rich diets improve body weight regulations and are thus believed to play a key role in combating the global obesity epidemic. Protein-rich diets are generally high in meats, some of which have become controverted enough to be considered disease-promoting foods despite their nutritional richness. The degree at which associations with disease differs from causality is however not entirely known.
Assessment of food intake currently relies on food frequency questionnaires (FFQ), 24h recall and dietary records, all of which are self-reporting methods known to be subject to bias and inaccuracy. Biomarkers of food intake emerged thus within the past years to complement the conventional tools as objective measurements of food intake, drawn from biological samples. Several biomarkers of meat consumption have been proposed, however none is currently accepted and used as biomarker(s) of meat intake and none is able to differentiate between the different types of meat.
In the modern diet, meats are very often served with potatoes. To our knowledge, biomarkers of potato intake have not been thoroughly reported in the literature. Different cooking methods were shown to potentially influence the content of bioactive constituents of vegetables, their glycemic index, as well as subsequent energy intake. High heat cooking additionally yields the formation of potentially toxic compounds such as advanced glycation endproducts (AGEs) that were shown to contribute to insulin resistance and type 2 diabetes. In this line, biomarkers of potatoes as such as well as biomarkers to differentiate between different cooking methods would be of great importance in advancing the understanding of nutritional science.
Primary objectives:
- To identify acute biomarkers of general meat intake by untargeted metabolomics
- To explore the changes in the metabolome as a result of acute exposure to three types of meat and identify meat-specific biomarkers of intake
- To identify biomarkers of acute potato intake by untargeted metabolomics
- To identify biomarkers that can differentiate between three types of cooking methods
- To investigate the effect of the interaction between meat on potatoes on satiety, assessed by registration of intake from an ad libitum meal
Secondary objectives:
- To validate already known biomarkers of meat intake by targeted metabolomics
- To investigate the effect of the interaction between meat and potatoes on satiety, assessed by visual analogue scales
- To investigate the effect of the interaction between meat and potatoes on glucose and insulin responses
- Being tested
- Meal sequence: 3C1A2B4D, Meal sequence: 2A3D4C1B, Meal sequence: 2D4B3A1C, Meal sequence: 3B2C1D4A, Meal sequence: 4C2B1A3D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal sequence: 3C1A2B4DOther
Participants receive test meals in the sequence 3C1A2B4D
Meal sequence: 2A3D4C1BOther
Participants receive test meals in the sequence 2A3D4C1B
Meal sequence: 2D4B3A1COther
Participants receive test meals in the sequence 2D4B3A1C
Meal sequence: 3B2C1D4AOther
Participants receive test meals in the sequence 3B2C1D4A
Meal sequence: 4C2B1A3DOther
Participants receive test meals in the sequence 4C2B1A3D
Meal sequence:1B4D3C2AOther
Participants receive test meals in the sequence 1B4D3C2A
Meal sequence:4A1C2D3BOther
Participants receive test meals in the sequence 4A1C2D3B
Meal sequence:1D3A4B2COther
Participants receive test meals in the sequence 1D3A4B2C
Meal sequence: 4D3B2C1AOther
Participants receive test meals in the sequence 4D3B2C1A
Meal sequence: 3A4C1B2DOther
Participants receive test meals in the sequence 3A4C1B2D
Meal sequence: 1C2A3D4BOther
Participants receive test meals in the sequence 1C2A3D4B
Meal sequence: 2B1D4A3COther
Participants receive test meals in the sequence 2B1D4A3C
| Study group | Role | What they receive |
|---|---|---|
| Meal sequence: 3C1A2B4D | Experimental | In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.
Each participants randomized to this arm is exposed to 4 test meals in the order 3C1A2B4D. Receives: Other: Meal sequence: 3C1A2B4D |
| Meal sequence: 2A3D4C1B | Experimental | In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.
Each participants randomized to this arm is exposed to 4 test meals in the order 2A3D4C1B. Receives: Other: Meal sequence: 2A3D4C1B |
| Meal sequence: 2D4B3A1C | Experimental | In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.
Each participants randomized to this arm is exposed to 4 test meals in the order 2D4B3A1C. Receives: Other: Meal sequence: 2D4B3A1C |
| Meal sequence: 3B2C1D4A | Experimental | In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.
Each participants randomized to this arm is exposed to 4 test meals in the order 3B2C1D4A. Receives: Other: Meal sequence: 3B2C1D4A |
| Meal sequence: 4C2B1A3D | Experimental | In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.
Each participants randomized to this arm is exposed to 4 test meals in the order 4C2B1A3D. Receives: Other: Meal sequence: 4C2B1A3D |
| Meal sequence:1B4D3C2A | Experimental | In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.
Each participants randomized to this arm is exposed to 4 test meals in the order 1B4D3C2A. Receives: Other: Meal sequence:1B4D3C2A |
| Meal sequence:4A1C2D3B | Experimental | In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.
Each participants randomized to this arm is exposed to 4 test meals in the order 4A1C2D3B. Receives: Other: Meal sequence:4A1C2D3B |
| Meal sequence:1D3A4B2C | Experimental | In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.
Each participants randomized to this arm is exposed to 4 test meals in the order 1D3A4B2C. Receives: Other: Meal sequence:1D3A4B2C |
| Meal sequence: 4D3B2C1A | Experimental | In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.
Each participants randomized to this arm is exposed to 4 test meals in the order 4D3B2C1A. Receives: Other: Meal sequence: 4D3B2C1A |
| Meal sequence: 3A4C1B2D | Experimental | In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.
Each participants randomized to this arm is exposed to 4 test meals in the order 3A4C1B2D. Receives: Other: Meal sequence: 3A4C1B2D |
| Meal sequence: 1C2A3D4B | Experimental | In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.
Each participants randomized to this arm is exposed to 4 test meals in the order 1C2A3D4B. Receives: Other: Meal sequence: 1C2A3D4B |
| Meal sequence: 2B1D4A3C | Experimental | In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.
Each participants randomized to this arm is exposed to 4 test meals in the order 2B1D4A3C. Receives: Other: Meal sequence: 2B1D4A3C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary meat metabolites (metabolic profiling with mass spectrometry)
Explorative approach to discover biomarkers of general meat intake and to differentiate between different types of meat
Measured: Hours 0-48
Plasma meat metabolites (metabolic profiling with mass spectrometry)
Explorative approach to discover biomarkers related to general meat intake and/or specific types of meat
Measured: Hours 0-48
Urinary potato metabolites (metabolic profiling with mass spectrometry)
Explorative approach to discover biomarkers of general potato intake and to differentiate between different cooking methods
Measured: Hours 0-48
Plasma potato metabolites (metabolic profiling with mass spectrometry)
Explorative approach to discover biomarkers related to general potato intake and/or related to different cooking methods
Measured: Hours 0-48
Objective assessment of satiety
Measured by the weight of an ad libitum meal
Measured: Hours 0-7
Secondary outcomes (4)
Urine biomarkers of meat intake
Targeted approach with mass spectrometry on already proposed meat biomarkers
Measured: Hours 0-48
Subjective assessment of satiety
Assessed by visual analogue scale (VAS)
Measured: Hours 0-6
Area under the curve for glucose
Glucose is measure at 0, 45, 90, 120, and 180 min after the test meal and the area is determined by the trapezoid method.
Measured: Minutes 0-180
Area under the curve for insulin
Insulin is measure at 0, 45, 90, 120, and 180 min after the test meal and the area is determined by the trapezoid method.
Measured: Minutes 0-180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start15 Feb 2015
- Primary completion30 May 2015
- Study completion30 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biomarkers of Food Intake in 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Lars Ove Dragsted, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305718
- Sponsor's protocol ID
- H-15020401
- Acronym
- MEPO
- Status last verified
- Oct 2017
- First submitted
- 4 Oct 2017
- Last updated
- 10 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Meats and Potatoes Intake: a Meal Study in Healthy Men and Women - the MEPO Study.
- ClinicalTrials.gov ID
- NCT03305718
- Acronym / sponsor ID
- MEPO / H-15020401
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 15 Feb 2015 (actual)
- Primary completion
- 30 May 2015 (actual)
- Study completion
- 30 May 2015 (actual)
- First posted
- 10 Oct 2017 (actual)
- 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 discovery of biomarkers for the intake of meats and potatoes is needed for an accurate assessment of the intake of these foods. Twelve healthy subjects were enrolled in a controlled, cross-over meal study, randomized by a Latin square design. The test meals contained 1) beef, pork, chicken and a control meal for the meats and 2) french fries, boiled potatoes, chips and a control for the potato meals. A standardized diet was provided during sample collection. Blood and urine samples were collected up to 48h primarily for untargeted metabolomic profiling. Blood was further collected to study the effect of the meals on insulin and glycemic responses. Effects on satiety were measured by VAS and an ad libitum lunch following the test meals.
Detailed description
Protein-rich diets improve body weight regulations and are thus believed to play a key role in combating the global obesity epidemic. Protein-rich diets are generally high in meats, some of which have become controverted enough to be considered disease-promoting foods despite their nutritional richness. The degree at which associations with disease differs from causality is however not entirely known.
Assessment of food intake currently relies on food frequency questionnaires (FFQ), 24h recall and dietary records, all of which are self-reporting methods known to be subject to bias and inaccuracy. Biomarkers of food intake emerged thus within the past years to complement the conventional tools as objective measurements of food intake, drawn from biological samples. Several biomarkers of meat consumption have been proposed, however none is currently accepted and used as biomarker(s) of meat intake and none is able to differentiate between the different types of meat.
In the modern diet, meats are very often served with potatoes. To our knowledge, biomarkers of potato intake have not been thoroughly reported in the literature. Different cooking methods were shown to potentially influence the content of bioactive constituents of vegetables, their glycemic index, as well as subsequent energy intake. High heat cooking additionally yields the formation of potentially toxic compounds such as advanced glycation endproducts (AGEs) that were shown to contribute to insulin resistance and type 2 diabetes. In this line, biomarkers of potatoes as such as well as biomarkers to differentiate between different cooking methods would be of great importance in advancing the understanding of nutritional science.
Primary objectives:
- To identify acute biomarkers of general meat intake by untargeted metabolomics
- To explore the changes in the metabolome as a result of acute exposure to three types of meat and identify meat-specific biomarkers of intake
- To identify biomarkers of acute potato intake by untargeted metabolomics
- To identify biomarkers that can differentiate between three types of cooking methods
- To investigate the effect of the interaction between meat on potatoes on satiety, assessed by registration of intake from an ad libitum meal
Secondary objectives:
- To validate already known biomarkers of meat intake by targeted metabolomics
- To investigate the effect of the interaction between meat and potatoes on satiety, assessed by visual analogue scales
- To investigate the effect of the interaction between meat and potatoes on glucose and insulin responses
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Meal sequence: 3C1A2B4D | Experimental | Other: Meal sequence: 3C1A2B4DIn this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 3C1A2B4D. |
| Meal sequence: 2A3D4C1B | Experimental | Other: Meal sequence: 2A3D4C1BIn this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 2A3D4C1B. |
| Meal sequence: 2D4B3A1C | Experimental | Other: Meal sequence: 2D4B3A1CIn this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 2D4B3A1C. |
| Meal sequence: 3B2C1D4A | Experimental | Other: Meal sequence: 3B2C1D4AIn this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 3B2C1D4A. |
| Meal sequence: 4C2B1A3D | Experimental | Other: Meal sequence: 4C2B1A3DIn this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 4C2B1A3D. |
| Meal sequence:1B4D3C2A | Experimental | Other: Meal sequence:1B4D3C2AIn this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 1B4D3C2A. |
| Meal sequence:4A1C2D3B | Experimental | Other: Meal sequence:4A1C2D3BIn this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 4A1C2D3B. |
| Meal sequence:1D3A4B2C | Experimental | Other: Meal sequence:1D3A4B2CIn this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 1D3A4B2C. |
| Meal sequence: 4D3B2C1A | Experimental | Other: Meal sequence: 4D3B2C1AIn this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 4D3B2C1A. |
| Meal sequence: 3A4C1B2D | Experimental | Other: Meal sequence: 3A4C1B2DIn this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 3A4C1B2D. |
| Meal sequence: 1C2A3D4B | Experimental | Other: Meal sequence: 1C2A3D4BIn this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 1C2A3D4B. |
| Meal sequence: 2B1D4A3C | Experimental | Other: Meal sequence: 2B1D4A3CIn this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta. Each participants randomized to this arm is exposed to 4 test meals in the order 2B1D4A3C. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- BMI < 30 kg/m2
- Eating and tolerating meat, egg, pea, rice, and potatoes
- No current chronic or infectious disease
- No medication (oral contraceptive pill and mild antidepressants is allowed)
- No dietary supplements
Key exclusion criteria (7 listed)
- Any condition that makes the project responsible researcher to doubt the feasibility of the volunteer's participation
- Pregnant or lactating women
- Smoking (12 months of non-smoking is allowed)
- Vegan or vegetarian
- Have or have had a drug addiction
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 |
|---|---|---|
| Meal sequence: 3C1A2B4DParticipants receive test meals in the sequence 3C1A2B4D | Other | Meal sequence: 3C1A2B4D |
| Meal sequence: 2A3D4C1BParticipants receive test meals in the sequence 2A3D4C1B | Other | Meal sequence: 2A3D4C1B |
| Meal sequence: 2D4B3A1CParticipants receive test meals in the sequence 2D4B3A1C | Other | Meal sequence: 2D4B3A1C |
| Meal sequence: 3B2C1D4AParticipants receive test meals in the sequence 3B2C1D4A | Other | Meal sequence: 3B2C1D4A |
| Meal sequence: 4C2B1A3DParticipants receive test meals in the sequence 4C2B1A3D | Other | Meal sequence: 4C2B1A3D |
| Meal sequence:1B4D3C2AParticipants receive test meals in the sequence 1B4D3C2A | Other | Meal sequence:1B4D3C2A |
| Meal sequence:4A1C2D3BParticipants receive test meals in the sequence 4A1C2D3B | Other | Meal sequence:4A1C2D3B |
| Meal sequence:1D3A4B2CParticipants receive test meals in the sequence 1D3A4B2C | Other | Meal sequence:1D3A4B2C |
| Meal sequence: 4D3B2C1AParticipants receive test meals in the sequence 4D3B2C1A | Other | Meal sequence: 4D3B2C1A |
| Meal sequence: 3A4C1B2DParticipants receive test meals in the sequence 3A4C1B2D | Other | Meal sequence: 3A4C1B2D |
| Meal sequence: 1C2A3D4BParticipants receive test meals in the sequence 1C2A3D4B | Other | Meal sequence: 1C2A3D4B |
| Meal sequence: 2B1D4A3CParticipants receive test meals in the sequence 2B1D4A3C | Other | Meal sequence: 2B1D4A3C |
Primary outcome
Urinary meat metabolites (metabolic profiling with mass spectrometry)
Time frame: Hours 0-48
Explorative approach to discover biomarkers of general meat intake and to differentiate between different types of meat
Plasma meat metabolites (metabolic profiling with mass spectrometry)
Time frame: Hours 0-48
Explorative approach to discover biomarkers related to general meat intake and/or specific types of meat
Urinary potato metabolites (metabolic profiling with mass spectrometry)
Time frame: Hours 0-48
Explorative approach to discover biomarkers of general potato intake and to differentiate between different cooking methods
Plasma potato metabolites (metabolic profiling with mass spectrometry)
Time frame: Hours 0-48
Explorative approach to discover biomarkers related to general potato intake and/or related to different cooking methods
Objective assessment of satiety
Time frame: Hours 0-7
Measured by the weight of an ad libitum meal
4 secondary outcomes
Urine biomarkers of meat intake
Time frame: Hours 0-48
Subjective assessment of satiety
Time frame: Hours 0-6
Area under the curve for glucose
Time frame: Minutes 0-180
Area under the curve for insulin
Time frame: Minutes 0-180
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 10 Oct 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.
Questions about this trial
What is this clinical trial studying?
A study testing Meal sequence: 3C1A2B4D, Meal sequence: 2A3D4C1B and Meal sequence: 2D4B3A1C in people with Biomarkers of Food Intake in Healthy Subjects, run by University of Copenhagen.
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 6 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 10 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Urinary meat metabolites (metabolic profiling with mass spectrometry) (time frame: Hours 0-48). The study lists 5 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 10 Oct 2017.