Impact of a Short-Term Mediterranean-Style Diet on Health Indices (MEDWELL)
15 de julio de 2026 actualizado por: DR ADELE COSTABILE, University of Roehampton
Exploring the Effects of a Short-term Mediterranean-style Dietary Intervention on Indices of Mood and Wellbeing in UK Adults
Emerging evidence suggests protective properties of a Mediterranean diet (MD) in relation to prevention and management of mood disorders.
However, there is paucity of dietary interventions investigating adherence to MD and effects on mood and wellbeing in individuals without a clinical diagnosis.
The present study aimed to investigate the effects of adherence to a short-term MD on mood and wellbeing in healthy adults
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a 1-week, cross-over, randomised, controlled study investigating the effects of Mediterranean style diet on perceived mood and overall wellbeing in healthy adults.
The intervention consists following daily for 1 week a Mediterranean style eating pattern.
Participants are following their habitual diet during the control week.
This is an investigator-initiated, randomised, cross-over, controlled study.
Tipo de estudio
Intervencionista
Inscripción (Actual)
22
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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UK
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London, UK, Reino Unido, SW15 4JD
- University of Roehampton, School of Life and Health Sciences
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Habitual diet of low Mediterranean Diet (MD)adherence i.e. individuals with MD scoring ≤7 (low adherence) were included.
- Living in UK
Exclusion Criteria:
- pregnant or breastfeeding following a weight loss diet
- diagnosed medical condition (diabetes, cardiovascular disease, cancer, food allergies)
- have any further health conditions which may cause you to react adversely whilst changing your diet.
- diagnosed with a neurological impairment or psychiatric disorder
- Current smoker (last 12 months)
- history of substance abuse
- taking dietary supplements
- already following a Mediterranean style diet
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: A Mediterranean style diet
At baseline, participants attended an Educational Group Session (EGS) introducing the principles of the Mediterranean Diet (MD), including recommended foods, foods to limit, cooking methods, and shopping tips.
Participants then followed a Mediterranean-style diet for 7 days, replacing typical Western foods with MD alternatives without restricting energy intake.
Practical examples and take-home materials with simple food swaps were provided to support adherence.
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At baseline, an Educational Group Session (EGS) introduced participants to the Mediterranean Diet (MD) principles to support adherence.
The interactive EGS covered MD typical foods to consume and avoid, cooking methods, and practical shopping guidance.
Following the EGS, participants adopted a Mediterranean-style diet for a period of 7 days.
Participants were encouraged to follow the MD guidelines (replacing typical western foods with MD foods) without restricting energy intake; examples were provided during the EGS and with take-home resource materials which detailed 'simple swaps' or alternative MD food items to replace western food items.
Otros nombres:
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Comparador de placebos: Habitual diet
Participants were instructed to follow their habitual diet (control) and eating practices for 7 days.
without restricting energy intake.
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participants were instructed to follow their habitual diet (control) and eating practices for 7 days.
without restricting energy intake.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mood
Periodo de tiempo: Baseline and 7 days (final day of each condition) espressed in questionnaire scores
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Change in mood measured using the Bond-Lader Visual Analogue Scale (VAS).
The scale ranges from 0 to 100, with higher scores indicating a more positive mood state (better outcome).
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Baseline and 7 days (final day of each condition) espressed in questionnaire scores
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Wellbeing
Periodo de tiempo: Baseline and 7 days (final day of each condition) espressed in questionnaire scores
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Change in wellbeing measured using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS).
The WEMWBS total score ranges from 14 to 70, with higher scores indicating greater mental wellbeing (better outcome).
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Baseline and 7 days (final day of each condition) espressed in questionnaire scores
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Body weight
Periodo de tiempo: Baseline and 7 days (final day of each condition) expressed in Kg
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Change in body weight, measured in kilograms (kg) Change in waist circumference, measured in centimetres (cm). Lower waist circumference indicates a better outcome where reduction in central adiposity is a study objective. |
Baseline and 7 days (final day of each condition) expressed in Kg
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Physical activity
Periodo de tiempo: Baseline and 7 days (final day of each condition) espressed in questionnaire scores
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Change in physical activity measured using the International Physical Activity Questionnaire (IPAQ), expressed as total metabolic equivalent (MET)-minutes per week.
Higher scores indicate greater physical activity levels (better outcome).
The IPAQ does not have a fixed minimum or maximum score.
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Baseline and 7 days (final day of each condition) espressed in questionnaire scores
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Dietary intake
Periodo de tiempo: During the 7 days intervention/condition using DietPlan software
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Change in dietary intake assessed using 7-day weighted food records collected during each 7-day intervention period.
Dietary intake was quantified as daily energy and nutrient intake.
There is no fixed minimum or maximum score; values are reported in their respective units (e.g., kcal/day, g/day).
The direction of a better outcome depends on the specific dietary component being evaluated.
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During the 7 days intervention/condition using DietPlan software
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Fotini Tsofliou, University of Roehampton
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de marzo de 2019
Finalización primaria (Actual)
12 de mayo de 2019
Finalización del estudio (Actual)
20 de agosto de 2019
Fechas de registro del estudio
Enviado por primera vez
19 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
15 de julio de 2026
Publicado por primera vez (Actual)
16 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
15 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- MED-MOOD-UK-2026-001
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .