- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07707414
Impact of a Short-Term Mediterranean-Style Diet on Health Indices (MEDWELL)
15. juli 2026 oppdatert av: 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
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
22
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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UK
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London, UK, Storbritannia, SW15 4JD
- University of Roehampton, School of Life and Health Sciences
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: 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.
|
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.
Andre navn:
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Placebo komparator: Habitual diet
Participants were instructed to follow their habitual diet (control) and eating practices for 7 days.
without restricting energy intake.
|
participants were instructed to follow their habitual diet (control) and eating practices for 7 days.
without restricting energy intake.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Mood
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Wellbeing
Tidsramme: 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).
|
Baseline and 7 days (final day of each condition) espressed in questionnaire scores
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Body weight
Tidsramme: Baseline and 7 days (final day of each condition) expressed in Kg
|
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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Fotini Tsofliou, University of Roehampton
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mars 2019
Primær fullføring (Faktiske)
12. mai 2019
Studiet fullført (Faktiske)
20. august 2019
Datoer for studieregistrering
Først innsendt
19. juni 2026
Først innsendt som oppfylte QC-kriteriene
15. juli 2026
Først lagt ut (Faktiske)
16. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- MED-MOOD-UK-2026-001
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