The Effect of Dietary Fibre and Plant Protein on Appetite and Metabolic Function
21 de outubro de 2013 atualizado por: Isabella Lee, Swedish University of Agricultural Sciences
The Combined Effect of Dietary Fibre and Plant Protein on Appetite and Metabolic Function After Short-Term Consumption
Acute effects on appetite and metabolic function have been observed for whole-grain rye cereal products.
The aim of this study is to evaluate if the appetite suppressing effect of a whole-grain rye breakfast cereal may be further enhanced by the addition of fermentable dietary fibre and plant protein.
The aim is also to try to elucidate how observed effects on subjective appetite are mediated in terms of changes in hormonal signals, flow of nutrients in the blood and products from bacterial fermentation of dietary fibre, and to relate this to the different composition of the breakfasts.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
The short-term effects (up to 8 hours after intake) of dietary fibre and plant protein on subjective appetite and metabolism will be evaluated using a randomized cross-over study design.
Each participant will consume six different breakfasts on six different occasions separated by a 1 week wash-out period: three rye porridges supplemented with three different combinations of added fermentable dietary fibre and plant protein, two non-supplemented rye porridges differing in amount of rye and one wheat bread.
Participants will rate subjective appetite (satiety, hunger and desire to eat) by using a visual analog scale (VAS) every 30 min during an 8-hour period, starting 30 min before breakfast.
The concentration of hydrogen and methane in the breath, as indicators of bacterial fermentation of dietary fibre, will be measured every hour.
Blood samples will be collected before breakfast and at regular intervals throughout the day for analysis of glucose and hormone levels.
The metabolic profile in the blood will be assessed as well as products from bacterial fermentation of dietary fibre, such as short chain fatty acids.
Gastric emptying rate will also be evaluated using paracetamol as an indicator.
Hormonal responses, changes in the metabolome and fermentation products will be related to subjective appetite and to differences in composition of the breakfasts.
Tipo de estudo
Intervencional
Inscrição (Real)
22
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Uppsala, Suécia, SE-751 85
- Paediatric Research Facility; The Children's Hospital at Uppsala University Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 60 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Women must be post-menopausal or habitually take hormonal contraceptives
- Habitual breakfast eaters
Exclusion Criteria:
- Non-contraceptive use among pre-menopausal women
- Pregnancy, lactation or wishing to become pregnant during the study period
- Dieting
- Weightloss
- Eating disorder
- Hyperglycemic
- Hyperinsulinemic
- Thyroid disease
- Metabolic issues
- Diabetes
- Physical or psychological problems eating
- Food intolerances/allergies to foods included in the study
- Vegetarians
- Intolerance/allergy to paracetamol
- Heavy smokers
- Recent or concurrent participation in an intervention research study
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
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 |
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Experimental: Rye + high dose inulin + low dose gluten
Rye porridge supplemented with a high dose of the fermentable dietary fibre inulin and low dose of the plant protein gluten.
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In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
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Experimental: Rye + equal doses of inulin & gluten
Rye porridge supplemented with equal doses of the fermentable dietary fibre inulin and the plant protein gluten.
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In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
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Experimental: Rye + low dose inulin + high dose gluten
Rye porridge supplemented with a low dose of the fermentable dietary fibre inulin and a high dose of the plant protein gluten.
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In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
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Experimental: Large non-supplemented rye
Large portion of rye porridge without supplements.
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In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
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Experimental: Small non-supplemented rye
Small portion of rye porridge without supplements.
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In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
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Comparador Ativo: Refined wheat bread
Refined wheat bread.
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In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Subjective appetite profiles
Prazo: 8 h (-30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, 480)
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Subjective feelings of appetite (satiety, hunger and desire to eat) are assessed by visual analogue scale (VAS) (in total 18 measurements).
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8 h (-30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, 480)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Breath hydrogen and methane response
Prazo: 8 h (-30, 30, 90, 150, 210, 270, 330, 390, 450, 480)
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Measurements of the concentration of breath hydrogen and methane(in total 10 measurements).
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8 h (-30, 30, 90, 150, 210, 270, 330, 390, 450, 480)
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Gastric emptying rate
Prazo: 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
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Paracetamol (1 g) was taken with breakfast.
The appearance of paracetamol in the blood is directly related to the rate of gastric emptying.
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8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
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Glucose and hormonal response
Prazo: 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
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Glucose, insulin, glucagon, glucagon-like peptide-1 (GLP-1), glucose-dependent insulino-tropic polypeptide (GIP), peptide YY (PYY), cholecystokinin (CCK), leptin and ghrelin are measured in plasma samples.
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8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
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Metabolic profiles
Prazo: 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
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The flux of nutrients is measured in plasma samples.
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8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
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Products from bacterial fermentation of dietary fibre
Prazo: 8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
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Products from bacterial fermentation of dietary fibre are measured in plasma samples.
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8 h (-15, 15, 35, 65, 95, 125, 185, 230, 275, 305, 365, 470)
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Ad libitum food intake
Prazo: 8 h after breakfast (480 min)
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Energy intakes will be assessed from the ad libitum dinner in order to validate subjective appetite measurements.
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8 h after breakfast (480 min)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Rikard K Landberg, Ass. Prof., Swedish University of Agricultural Sciences
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de março de 2013
Conclusão Primária (Real)
1 de agosto de 2013
Conclusão do estudo (Real)
1 de agosto de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
16 de setembro de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
15 de outubro de 2013
Primeira postagem (Estimativa)
18 de outubro de 2013
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
22 de outubro de 2013
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de outubro de 2013
Última verificação
1 de outubro de 2013
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- SLU-IL-S1
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