NCT07707414

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2019

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2026

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 16, 2026

Completed
Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

June 19, 2026

Last Update Submit

July 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mood

    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 Outcomes (1)

  • Wellbeing

    Baseline and 7 days (final day of each condition) espressed in questionnaire scores

Other Outcomes (3)

  • Body weight

    Baseline and 7 days (final day of each condition) expressed in Kg

  • Physical activity

    Baseline and 7 days (final day of each condition) espressed in questionnaire scores

  • Dietary intake

    During the 7 days intervention/condition using DietPlan software

Study Arms (2)

A Mediterranean style diet

ACTIVE COMPARATOR

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.

Other: A mediterranean style diet

Habitual diet

PLACEBO COMPARATOR

Participants were instructed to follow their habitual diet (control) and eating practices for 7 days. without restricting energy intake.

Other: Habitual Diet

Interventions

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.

Also known as: MD
A Mediterranean style diet

participants were instructed to follow their habitual diet (control) and eating practices for 7 days. without restricting energy intake.

Habitual diet

Eligibility Criteria

Age35 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Habitual diet of low Mediterranean Diet (MD)adherence i.e. individuals with MD scoring ≤7 (low adherence) were included.
  • Living in UK

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Roehampton, School of Life and Health Sciences

London, UK, SW15 4JD, United Kingdom

Location

Study Officials

  • Fotini Tsofliou

    University of Roehampton

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Open label
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: a randomised controlled-crossover design was employed, including a washout period to reduce carryover effects. Random allocation determined participants' diet order; counterbalanced to follow the MedDiet (MD) or their habitual diet (Control) for 7 days (week 1). This was followed by a washout (week 2), before participants completed the alternate condition (week 3). This is an investigator-initiated, randomised,controlled pilot study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Clinical Nutrition

Study Record Dates

First Submitted

June 19, 2026

First Posted

July 16, 2026

Study Start

March 1, 2019

Primary Completion

May 12, 2019

Study Completion

August 20, 2019

Last Updated

July 16, 2026

Record last verified: 2026-07

Locations