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Effects on Cognitive Functions and Mood of Food Products Rich in Polyphenols

6 de setembro de 2017 atualizado por: Anne Nilsson, Lund University

Food Design for Improved Cognitive Performance/Effects on Cognitive Functions and Mood of Food Products Rich in Polyphenols

The purpose of this study is to investigate effects of a selected food product rich in polyphenol on cognitive performance and mood.

Visão geral do estudo

Descrição detalhada

The metabolic syndrome (MetS) includes a cluster of dysfunctions that identifies subjects at risk of developing type-2 diabetes and cardiovascular disease (CVD). A key feature appears to be chronic increased inflammation and activation of the innate system. Consequently, increased low-grade inflammation has been connected to adverse effects on insulin sensitivity, glucose- and lipid metabolism, and blood pressure, and circulating markers of inflammation such as IL-6. A growing body of evidence also link low-grade inflammation to poorer cognitive functioning. Type 2 diabetes, MetS, and glucose intolerance are increasingly being associated with impaired cognition.

Dietary patterns which promote sub-clinical inflammation are increasingly being considered predictive of future risk of CVD and type-2 diabetes. Epidemiological data shows that a high consumption of vegetables and fruits is associated with a lowered risk of cancer and cardiovascular disease, which may be due to the high concentrations of polyphenols or other anti-oxidants that are found in such foods.

In the presently described project it is hypothesized that four weeks daily consumption of a product specific high in flavanols can improve metabolic risk variables and cognitive functions in healthy subjects.

The purpose is therefore to investigate effects of flavanols on cognitive functions and cardiometabolic risk, and to investigate relations between cardiometabolic risk markers and cognitive performance. The test product is a commonly used food product, known to be specifically rich in flavanols. The effects of the test product is compared with effects of a control product that is based on a similar food product but is lacking flavanols.

Test parameters:

Cognitive tests: Working memory tests (an oral test), selection attention test (measure also reaction time, a computerized test ), and stroop test (a computerized test.

Mood is determined for 6 different mood sensations using VAS scales.

Bio markers in blood: glucose regulation (glucose, insulin), markers of inflammation and oxidative stress (IL-6, MDA, oxLDL), blood lipids (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides), vascular function (P-Selectin, PAI-1, NO), gut hormones involved in metabolism and satiety (PYY, GLP-1) gut hormon involved in mucosa integrity (GLP-2), markers of brain function (BDNF, neurotensin).

Blood pressure.

Tipo de estudo

Intervencional

Inscrição (Real)

38

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

      • Lund, Suécia, 223 81
        • Lund Univercity, Medicon village, Functional Food Science Centre

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

50 anos a 70 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Healthy women and men
  • Between 50-70 years
  • BMI 19-25

Exclusion Criteria:

  • Metabolic diseases
  • Food allergies
  • Smoker

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: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Flavanol rich food product
A portion of a common flavanol rich food product is consumed daily for 4 weeks
polyphenol rich test product
Comparador de Placebo: Non-flavanol food product
A portion of a product similar to the experimental Product, but instead contains low amounts of flavanol, is consumed Daily for 4 weeks as a control.
polyphenol rich test product

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
working memory (WM) capacity
Prazo: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, working memory capacity is determined four times in the postprandial phase up to 3.5h after breakfast.
The test food product or control is consumed fasting, and after 30 min a standardised breakfast is served. WM tests are performed at 60 min, 120 min, 165 min and 210 min after commencing the intake of test Product. One test takes approximately 8 min to carry out.
Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, working memory capacity is determined four times in the postprandial phase up to 3.5h after breakfast.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
mood assessment
Prazo: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, subjects registered mood sensations at fasting and five times in the postprandial phase up to 3,5h after breakfast.

Self-reported sensations of mood and feelings of activation was assessed with a modified bipolar variant of the Swedish Core Affect Scales (SCAS) comprising six rating scales of two orthogonal dimensions of core affect: valence (unpleasantness-pleasantness) and activation (quietness-excitement).

Mood scales are filled out at fasting, prior to the standardised breakfast served after 30 min and directly after cognitive tests started at 60 min, 120 min, 165 min and 210 min after commencing the intake of test product.

Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, subjects registered mood sensations at fasting and five times in the postprandial phase up to 3,5h after breakfast.

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
blood pressure
Prazo: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, blood pressure is determined at fasting and four times in the postprandial phase up to 3,5h after breakfast.
Blood pressure is determined at fasting and at 60 min, 90 min, 150 min and 180 min, prior to other test variables collected at the same test Point.
Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, blood pressure is determined at fasting and four times in the postprandial phase up to 3,5h after breakfast.
glucose regulation
Prazo: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, blood glucose is determined fasting and then eight times in the postprandial phase up to 3.5h after the standardised breakfast
Blood glucose concentrations (determined in capillary blood), and insulin (determined in venous blood). Blood tests are collected repeatedly during 3h after a standardised breakfast consumed 30 min after commencing the test product/Control Product.
Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, blood glucose is determined fasting and then eight times in the postprandial phase up to 3.5h after the standardised breakfast
selective attention (SA)
Prazo: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, selective attention is determined three times in the postprandial phase up to 3.5h after the standardised breakfast
Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, selective attention is determined three times in the postprandial phase up to 3.5h after the standardised breakfast
Vascular function
Prazo: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, vascular marker is determined fasting and up to 3.5h after the standardised breakfast
Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, vascular marker is determined fasting and up to 3.5h after the standardised breakfast
Blood lipids
Prazo: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, blood lipids are determined fasting and up to 3.5h after the standardised breakfast
Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, blood lipids are determined fasting and up to 3.5h after the standardised breakfast
Marker of inflammation
Prazo: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, inflammatory markers in blood are determined fasting and up to 3.5h after the standardised breakfast
Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, inflammatory markers in blood are determined fasting and up to 3.5h after the standardised breakfast
Markers of oxidative stress
Prazo: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, markers of oxidative stress are determined in blood at fasting and then up to 3.5h after a standised breakfast
Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, markers of oxidative stress are determined in blood at fasting and then up to 3.5h after a standised breakfast
Gut peptides
Prazo: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, gut peptides are determined in blood at fasting
Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, gut peptides are determined in blood at fasting
markers of brain function
Prazo: Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, markers of brain finction are determined in blood at fasting
Each of the two intervention periods is 4 weeks. At the first and last day in each intervention periods, markers of brain finction are determined in blood at fasting
Stroop test
Prazo: Each of the two intervention periods is 4 weeks. At the first and last day Stroop tests are performed three times after a standardised breakfast up to 3,5h .
Each of the two intervention periods is 4 weeks. At the first and last day Stroop tests are performed three times after a standardised breakfast up to 3,5h .

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

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 janeiro de 2014

Conclusão Primária (Real)

1 de março de 2015

Conclusão do estudo (Real)

1 de março de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

10 de setembro de 2014

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de setembro de 2014

Primeira postagem (Estimativa)

18 de setembro de 2014

Atualizações de registro de estudo

Última Atualização Postada (Real)

8 de setembro de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de setembro de 2017

Última verificação

1 de setembro de 2017

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • AFC-2013/619

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