HealthyMEDWELLNCT07707414
Impact of a Short-Term Mediterranean-Style Diet on Health Indices
A study testing A mediterranean style diet and Habitual Diet in people with Healthy, run by University of Roehampton at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- A mediterranean style diet and Habitual Diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2019to 20 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Habitual diet of low Mediterranean Diet (MD)adherence i.e. individuals with MD scoring ≤7 (low adherence) were included.
- Living in UK
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Roehampton, School of Life and Health Sciences
London, UK, SW15 4JD
About this study
Official title: 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
Read the 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.
- Conditions
- Healthy
- Being tested
- A mediterranean style diet, Habitual Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A mediterranean style dietOther
Also called MD
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.
Habitual DietOther
participants were instructed to follow their habitual diet (control) and eating practices for 7 days. without restricting energy intake.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Habitual Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 7 days (final day of each condition) espressed in questionnaire scores
Secondary outcomes (1)
Wellbeing
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).
Measured: Baseline and 7 days (final day of each condition) espressed in questionnaire scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Mar 2019
- Primary completion12 May 2019
- Study completion20 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roehampton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR ADELE COSTABILE, University of Roehampton
- Investigators
- Fotini Tsofliou, Principal investigator, University of Roehampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707414
- Sponsor's protocol ID
- MED-MOOD-UK-2026-001
- Acronym
- MEDWELL
- Status last verified
- Jul 2026
- First submitted
- 19 Jun 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of a Short-term Mediterranean-style Dietary Intervention on Indices of Mood and Wellbeing in UK Adults
- ClinicalTrials.gov ID
- NCT07707414
- Acronym / sponsor ID
- MEDWELL / MED-MOOD-UK-2026-001
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of RoehamptonUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 12 May 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| A Mediterranean style diet | Active comparator | Other: A mediterranean style dietAt 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. |
| Habitual diet | Placebo comparator | Other: Habitual DietParticipants were instructed to follow their habitual diet (control) and eating practices for 7 days. without restricting energy intake. |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Habitual diet of low Mediterranean Diet (MD)adherence i.e. individuals with MD scoring ≤7 (low adherence) were included.
- Living in UK
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A mediterranean style dietAlso: MDAt 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 | A Mediterranean style diet |
| Habitual Dietparticipants were instructed to follow their habitual diet (control) and eating practices for 7 days. without restricting energy intake. | Other | Habitual diet |
Primary outcome
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).
1 secondary outcome
Wellbeing
Time frame: Baseline and 7 days (final day of each condition) espressed in questionnaire scores
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fotini Tsofliou principal investigator
University of Roehampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A mediterranean style diet and Habitual Diet in people with Healthy, run by University of Roehampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mood (time frame: Baseline and 7 days (final day of each condition) espressed in questionnaire scores). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.