Biomarkers of Meats and Potatoes Intake. (MEPO)
Biomarkers of Meats and Potatoes Intake: a Meal Study in Healthy Men and Women - the MEPO Study.
Visão geral do estudo
Status
Intervenção / Tratamento
- Outro: Meal sequence: 3C1A2B4D
- Outro: Meal sequence: 2A3D4C1B
- Outro: Meal sequence: 2D4B3A1C
- Outro: Meal sequence: 3B2C1D4A
- Outro: Meal sequence: 4C2B1A3D
- Outro: Meal sequence:1B4D3C2A
- Outro: Meal sequence:4A1C2D3B
- Outro: Meal sequence:1D3A4B2C
- Outro: Meal sequence: 4D3B2C1A
- Outro: Meal sequence: 3A4C1B2D
- Outro: Meal sequence: 1C2A3D4B
- Outro: Meal sequence: 2B1D4A3C
Descrição detalhada
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
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Meal sequence: 3C1A2B4D
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. |
Participants receive test meals in the sequence 3C1A2B4D
|
|
Experimental: Meal sequence: 2A3D4C1B
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. |
Participants receive test meals in the sequence 2A3D4C1B
|
|
Experimental: Meal sequence: 2D4B3A1C
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. |
Participants receive test meals in the sequence 2D4B3A1C
|
|
Experimental: Meal sequence: 3B2C1D4A
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. |
Participants receive test meals in the sequence 3B2C1D4A
|
|
Experimental: Meal sequence: 4C2B1A3D
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. |
Participants receive test meals in the sequence 4C2B1A3D
|
|
Experimental: Meal sequence:1B4D3C2A
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. |
Participants receive test meals in the sequence 1B4D3C2A
|
|
Experimental: Meal sequence:4A1C2D3B
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. |
Participants receive test meals in the sequence 4A1C2D3B
|
|
Experimental: Meal sequence:1D3A4B2C
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. |
Participants receive test meals in the sequence 1D3A4B2C
|
|
Experimental: Meal sequence: 4D3B2C1A
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. |
Participants receive test meals in the sequence 4D3B2C1A
|
|
Experimental: Meal sequence: 3A4C1B2D
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. |
Participants receive test meals in the sequence 3A4C1B2D
|
|
Experimental: Meal sequence: 1C2A3D4B
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. |
Participants receive test meals in the sequence 1C2A3D4B
|
|
Experimental: Meal sequence: 2B1D4A3C
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. |
Participants receive test meals in the sequence 2B1D4A3C
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Urinary meat metabolites (metabolic profiling with mass spectrometry)
Prazo: Hours 0-48
|
Explorative approach to discover biomarkers of general meat intake and to differentiate between different types of meat
|
Hours 0-48
|
|
Plasma meat metabolites (metabolic profiling with mass spectrometry)
Prazo: Hours 0-48
|
Explorative approach to discover biomarkers related to general meat intake and/or specific types of meat
|
Hours 0-48
|
|
Urinary potato metabolites (metabolic profiling with mass spectrometry)
Prazo: Hours 0-48
|
Explorative approach to discover biomarkers of general potato intake and to differentiate between different cooking methods
|
Hours 0-48
|
|
Plasma potato metabolites (metabolic profiling with mass spectrometry)
Prazo: Hours 0-48
|
Explorative approach to discover biomarkers related to general potato intake and/or related to different cooking methods
|
Hours 0-48
|
|
Objective assessment of satiety
Prazo: Hours 0-7
|
Measured by the weight of an ad libitum meal
|
Hours 0-7
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Urine biomarkers of meat intake
Prazo: Hours 0-48
|
Targeted approach with mass spectrometry on already proposed meat biomarkers
|
Hours 0-48
|
|
Subjective assessment of satiety
Prazo: Hours 0-6
|
Assessed by visual analogue scale (VAS)
|
Hours 0-6
|
|
Area under the curve for glucose
Prazo: Minutes 0-180
|
Glucose is measure at 0, 45, 90, 120, and 180 min after the test meal and the area is determined by the trapezoid method.
|
Minutes 0-180
|
|
Area under the curve for insulin
Prazo: Minutes 0-180
|
Insulin is measure at 0, 45, 90, 120, and 180 min after the test meal and the area is determined by the trapezoid method.
|
Minutes 0-180
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- H-15020401
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Meal sequence: 3C1A2B4D
-
University of LeedsConcluídoObesidade | Excesso de pesoReino Unido