- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07707414
Impact of a Short-Term Mediterranean-Style Diet on Health Indices (MEDWELL)
15 juli 2026 uppdaterad 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
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
22
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
UK
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London, UK, Storbritannien, SW15 4JD
- University of Roehampton, School of Life and Health Sciences
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / 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.
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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.
Andra namn:
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Placebo-jämförare: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Mood
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Wellbeing
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Body weight
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Fotini Tsofliou, University of Roehampton
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 mars 2019
Primärt slutförande (Faktisk)
12 maj 2019
Avslutad studie (Faktisk)
20 augusti 2019
Studieregistreringsdatum
Först inskickad
19 juni 2026
Först inskickad som uppfyllde QC-kriterierna
15 juli 2026
Första postat (Faktisk)
16 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
16 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- MED-MOOD-UK-2026-001
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