Impact of a Short-Term Mediterranean-Style Diet on Health Indices (MEDWELL)

July 15, 2026 updated by: 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

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • UK
      • London, UK, United Kingdom, SW15 4JD
        • University of Roehampton, School of Life and Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other Names:
  • MD
Placebo Comparator: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mood
Time Frame: Baseline and 7 days (final day of each condition) espressed in questionnaire scores
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).
Baseline and 7 days (final day of each condition) espressed in questionnaire scores

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wellbeing
Time Frame: Baseline and 7 days (final day of each condition) espressed in questionnaire scores
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight
Time Frame: 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
Physical activity
Time Frame: Baseline and 7 days (final day of each condition) espressed in questionnaire scores
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.
Baseline and 7 days (final day of each condition) espressed in questionnaire scores
Dietary intake
Time Frame: During the 7 days intervention/condition using DietPlan software
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.
During the 7 days intervention/condition using DietPlan software

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Fotini Tsofliou, University of Roehampton

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

May 12, 2019

Study Completion (Actual)

August 20, 2019

Study Registration Dates

First Submitted

June 19, 2026

First Submitted That Met QC Criteria

July 15, 2026

First Posted (Actual)

July 16, 2026

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 15, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • MED-MOOD-UK-2026-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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