- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04867655
Acute Effect of Orange Juice Mixed With Oat β-Glucan on Bioavailability of Polyphenols in Healthy Individuals
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Glasgow, Reino Unido, G31 2ER
- Human Nutrition, College of Medicine, Veterinary and Life Science
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Orange juice only
Experimental test for 24 hours after consumption of orange juice only (Tropicana 'with bits').
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Approximately 500 ml of orange juice will be consumed and then blood and urine samples will be collected for 24 hours
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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.
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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
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Plasma pharmacokinetics of naringenin, hesperetin, eriodictyol, isorhamnetin and phenolic acid metabolites including phenylpropionic acids, phenylacetic acid and benzoic acid derivatives
Periodo de tiempo: 24 hours
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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
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24 hours
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Urinary excretion of naringenin, hesperetin, eriodictyol, isorhamnetin and phenolic acid metabolites including phenylpropionic acids, phenylacetic acid and benzoic acid derivatives
Periodo de tiempo: 24 hours
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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)
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24 hours
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Body weight
Periodo de tiempo: 7 days
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Difference in body weight in kilograms between two experimental trials measured by TANITA scales (TBF-300, Cranela, UK).
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7 days
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Body fatness
Periodo de tiempo: 7 days
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Difference in percentage of body fat between two experimental trials measured by TANITA scales (TBF-300, Cranela, UK).
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7 days
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Dietary Intake
Periodo de tiempo: 3 days and 24 hours
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Difference in energy/macronutrient intake prior to and during the experimental trails measured from weighted food records
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3 days and 24 hours
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Dale Malkova, PhD, University of Glasgow
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- Glasgow University
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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