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Acute Effect of Orange Juice Mixed With Oat β-Glucan on Bioavailability of Polyphenols in Healthy Individuals

31 de outubro de 2021 atualizado por: Dr Dalia Malkova, University of Glasgow
Brief summary Orange juice is the most widely consumed fruit juice, accounting for around a third of the total fruit juice market and is a rich source of vitamin C and bioactive compounds, predominantly flavonoids. Current research into the health effects of fruit juice consumption has presented some conflicting conclusions. Although potential health benefits have been attributed to the anti-inflammatory and anti-oxidant properties of the bioactive components in juice, other studies have suggested that the benefits of consuming orange are outweighed by the negative implications of the high sugar content leading to increases in blood glucose and insulin. At the same time it is well established that supplementation with a mean dose of 5g of β-Glucan, a soluble fibre derived from cereals such as oats or barley, significantly reduces insulin and glucose in healthy subjects and metabolic compromised individuals. Thus, the formulation of an OJ beverage with an added β-Glucan supplement may be a useful strategy to attenuate the detrimental impact of high sugar content. However, while delaying the absorption of glucose brings about favourable effects on post-prandial glycemia, dietary fibre may also reduce the bioavailability of some beneficial compounds, including polyphenols. So far, it remains unclear how addition of β-Glucan impacts bioavailability of orange juice flavanones. Thus, this study aims to determine how the bioavailability of orange juice polyphenols of healthy adults is affected mixing orange juice with 3 g and 6 g of oat β-Glucan.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Descrição detalhada

Brief summary Orange juice is the most widely consumed fruit juice, accounting for around a third of the total fruit juice market and is a rich source of vitamin C and bioactive compounds, predominantly flavonoids. Current research into the health effects of fruit juice consumption has presented some conflicting conclusions. Although potential health benefits have been attributed to the anti-inflammatory and anti-oxidant properties of the bioactive components in juice, other studies have suggested that the benefits of consuming orange are outweighed by the negative implications of the high sugar content leading to increases in blood glucose and insulin. At the same time it is well established that supplementation with a mean dose of 5g of β-Glucan, a soluble fibre derived from cereals such as oats or barley, significantly reduces insulin and glucose in healthy subjects and metabolic compromised individuals. Thus, the formulation of an OJ beverage with an added β-Glucan supplement may be a useful strategy to attenuate the detrimental impact of high sugar content. However, while delaying the absorption of glucose brings about favourable effects on post-prandial glycemia, dietary fibre may also reduce the bioavailability of some beneficial compounds, including polyphenols. So far, it remains unclear how addition of β-Glucan impacts bioavailability of orange juice flavanones. Thus, this study aims to determine how the bioavailability of orange juice polyphenols of healthy adults is affected mixing orange juice with 3 g and 6 g of oat β-Glucan.

Eligible participants for this study will be healthy adults aged 18 - 50 years and with a BMI in the normal or overweight to obese range (≥20 kg/m2). Participants will be required to be non-smokers, with a stable weight for the previous 3 months, and not engage in regular strenuous physical activity. Other exclusion criteria will include suffering from any chronic disease, taking any medication, or following a special diet, including being vegetarian and vegan. Before being enrolled in the study, potential participants will attend a health screening session, in which they will complete a health screening and physical activity questionnaire

This study will be a randomised controlled cross-over trial in which each participant will complete two 24-h feeding trials. The experimental trials will be separated by a wash out period of at least 7 days. The order of trials will be randomised for each participant, using a random sequence generator. In the morning of the experimental trial participants will consumed approximately 500ml of OJ (Tropicana 'with bits') without or with Oatwell fibre supplement, providing either 6g or 3 g of β-Glucan. Blood samples and urinary fractions will be collected prior to (baseline) and for 24 hours after consumption of corresponding beverage. Participants will be asked to follow a special polyphenol-free diet and record weighted dietary intake for 2 days preceding each trial and during the day of the experimental trial.

Tipo de estudo

Intervencional

Inscrição (Antecipado)

16

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

      • Glasgow, Reino Unido, G31 2ER
        • Human Nutrition, College of Medicine, Veterinary and Life Science

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 50 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • healthy
  • BMI (20 kg/m2-35 kg/m2)
  • non-smoker
  • not taking any drug therapies
  • normal dietary habits

Exclusion Criteria:

  • history of gastrointestinal diseases
  • following a special diet
  • take vitamin supplements, prebiotics, probiotics
  • vegetarian
  • engaged in strenuous exercise training
  • heavy alcohol consumer
  • pregnant or breastfeeding (females)

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

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Orange juice only
Experimental test for 24 hours after consumption of orange juice only (Tropicana 'with bits').
Approximately 500 ml of orange juice will be consumed and then blood and urine samples will be collected for 24 hours
Experimental: Orange Juice mixed with either 6g or 3 g of β-Glucan
Experimental test for 24 hours after consumption of orange juice (Tropicana 'with bits') with either 6g or 3 g of β-Glucan.
Approximately 500 ml of orange juice mixed with either 6g or 3 g of β-Glucan will be consumed and then blood and urine samples will be collected for 24 hours

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Plasma pharmacokinetics of naringenin, hesperetin, eriodictyol, isorhamnetin and phenolic acid metabolites including phenylpropionic acids, phenylacetic acid and benzoic acid derivatives
Prazo: 24 hours
Change in plasma concentrations collected at base line (0 hours) and 0.5,1, 2, 3,4,5,6,7,8, and 24 hours after ingestion of orange juice
24 hours
Urinary excretion of naringenin, hesperetin, eriodictyol, isorhamnetin and phenolic acid metabolites including phenylpropionic acids, phenylacetic acid and benzoic acid derivatives
Prazo: 24 hours
Change in concentrations in urinary fraction collected at base line (0 hours) and after ingestion of orange juice (0-5, 5-8, 8-10, 10-24 hours)
24 hours

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Body weight
Prazo: 7 days
Difference in body weight in kilograms between two experimental trials measured by TANITA scales (TBF-300, Cranela, UK).
7 days
Body fatness
Prazo: 7 days
Difference in percentage of body fat between two experimental trials measured by TANITA scales (TBF-300, Cranela, UK).
7 days
Dietary Intake
Prazo: 3 days and 24 hours
Difference in energy/macronutrient intake prior to and during the experimental trails measured from weighted food records
3 days and 24 hours

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Cadeira de estudo: Dale Malkova, PhD, University of Glasgow

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 (Real)

10 de julho de 2019

Conclusão Primária (Antecipado)

4 de maio de 2022

Conclusão do estudo (Antecipado)

4 de maio de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

27 de abril de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de abril de 2021

Primeira postagem (Real)

30 de abril de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

2 de novembro de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

31 de outubro de 2021

Última verificação

1 de outubro de 2021

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • Glasgow University

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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 .

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