Body Weight ChangesNCT04185948
Pilot Study on the Impact of the Mediterranean Diet and Intermittent Fasting
A study testing Mediterranean diet guidelines plus intermittent fasting and UK Eatwell guidelines plus intermittent fasting in people with Body Weight Changes, run by Northumbria University at 1 site in United Kingdom.
Trial summary
This clinical trial attempts to evaluate the feasibility and acceptability of an intervention combining intermittent fasting and the Mediterranean diet guidelines vs an comparative intervention combining intermittent fasting but using the UK dietary guidelines. Read more about this study
- Who is it for?
- Ages 10 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight Changes
- What is being tested?
- Mediterranean diet guidelines plus intermittent fasting and UK Eatwell guidelines plus intermittent fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jan 2019to 27 Nov 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 10 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Aged 18-70 yrs BMI 25-39.9kg/m2, Able to attend university for measurement and educational sessions.
Who cannot join
- Cardiovascular problems or documented history of CVD including: angina; myocardial infarction; coronary revascularization procedures; stroke (ischemic or haemorrhagic, including transient ischemic attacks) symptomatic peripheral artery disease that required surgery or was diagnosed with vascular imaging techniques; ventricular arrhythmia; uncontrolled atrial fibrillation; congestive heart failure; hypertrophic myocardiopathy, or aortic aneurism,
- Active malignant cancer or history of malignancy within the last 5 years (except non-melanoma skin cancer)
- Issues affecting food intake e.g. dysphagia, severe allergies, food neophobia, strong dislike of foods in diet plan, or religious issues
- Lack of motivation to change diet/lifestyle (low likelihood as calculated according to the Prochaska and DiClemente Stages of Change Model)
- Lack of motivation to fast Medical reasons not allowing very low calorie intake, type 1 or 2 diabetes
- Pregnancy or hoping to become pregnant, or breastfeeding
Show all 14Show fewer
- Current adherence to other weight loss or exercise program
- Illiteracy or inability/unwillingness to give written informed consent or communicate with study staff
- Institutionalization
- History of surgical procedures for weight loss or intention to undergo bariatric surgery in the next 12 months
- Obesity of known endocrine origin (e.g. hypothyroidism, polycystic ovarian syndrome)
- Serious psychiatric disorders including: schizophrenia, bipolar disorder, eating disorders, or depression with hospitalization within the last 6 months
- Alcohol abuse or addiction (or total daily alcohol intake >50 g) or drug abuse within the past 6 months
- Current use of weight loss medication
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Applied Sciences, Faculty of Health and Life Sciences, Northumbria University
Newcastle upon Tyne, NE1 8ST
About this study
Official title: A Pilot Study Investigating the Acceptability and Impact of the Mediterranean Diet and Intermittent Fasting
This clinical trial attempts to evaluate the feasibility and acceptability of an intervention combining intermittent fasting and the Mediterranean diet guidelines vs an comparative intervention combining intermittent fasting but using the UK dietary guidelines.
Participants will be randomised to these intervention using a parallel design. Weight change and blood lipids will be assessed.
Read the detailed description
This study will have a randomised parallel study comparing two interventions involving intermittent fasting. One of the interventions will use the Mediterranean dietary guidelines proposed by the Mediterranean Diet Foundation, the other intervention will use the UK dietary guidelines (Eatwell Guide).
In this study, the interventions will require participants to adopt these interventions for 4 weeks. A basic website containing support information will be develop for each of these interventions.
Baseline measurements will be taken at the start of the study. Blood samples will be obtained in a fasted state before and after 4-week study period.
Anthropometric and body composition measurements including height and weight, waist circumference, bioelectrical impedance will be collected by researcher. Physical activity will be assessed using accelerometers.
- Conditions
- Body Weight Changes
- Being tested
- Mediterranean diet guidelines plus intermittent fasting, UK Eatwell guidelines plus intermittent fasting
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean diet guidelines plus intermittent fastingBehavioural
For 4 weeks participants will be encouraged to adopt the Mediterranean dietary guidelines as recommended by the Mediterranean Diet Foundation in Barcelona, Spain. In combination with these guidelines, an intermittent fasting regime involving two days of the week will be implemented. The regime will encourage individuals to consume of 500kcal per day for women and 625kcal per day for men, resulting in 75% daily caloric restriction during each of these two days.
UK Eatwell guidelines plus intermittent fastingBehavioural
For 4 weeks participants will be encouraged to adopt the UK dietary guidelines (Eatwell Guide). In combination with these guidelines, an intermittent fasting regime involving two days of the week will be implemented. The regime will encourage individuals to consume of 500kcal per day for women and 625kcal per day for men, resulting in 75% daily caloric restriction during each of these two days.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean diet plus intermittent fasting | Experimental | For 4 weeks participants will be encouraged to adopt the Mediterranean dietary guidelines as recommended by the Mediterranean Diet Foundation in Barcelona, Spain. In combination with these guidelines, an intermittent fasting regime involving two days of the week will be implemented. The regime will encourage individuals to consume of 500kcal per day for women and 625kcal per day for men, resulting in 75% daily caloric restriction during each of these two days. Receives: Behavioral: Mediterranean diet guidelines plus intermittent fasting |
| Eatwell guide plus intermittent fasting | Active comparator | For 4 weeks participants will be encouraged to adopt the UK dietary guidelines (Eatwell Guide). In combination with these guidelines, an intermittent fasting regime involving two days of the week will be implemented. The regime will encourage individuals to consume of 500kcal per day for women and 625kcal per day for men, resulting in 75% daily caloric restriction during each of these two days. Receives: Behavioral: UK Eatwell guidelines plus intermittent fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability of intervention
Participants will complete a questionnaire directed to obtain early markers of how the intervention is used
Measured: 4 weeks
Secondary outcomes (4)
Total cholesterol
Plasma levels of total cholesterol
Measured: 4 weeks
Weight change
Weight change after intervention
Measured: 4 weeks
Change from baseline dietary intake
Participants will self-report dietary intake using the 24-hour dietary recall method. Three days (including 2 weekdays and 1 weekend day) of dietary intake at baseline and after two months will be reported.
Measured: 4 weeks
Change from baseline physical activity levels at 2 months
Physical activity will be assessed assessed during seven days at baseline and after 2 months interventions by accelerometry.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start19 Jan 2019
- Primary completion31 Aug 2019
- Study completion27 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Weight ChangesStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Lara Gallegos, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185948
- Sponsor's protocol ID
- HLS-JLG-2019
- Status last verified
- Dec 2019
- First submitted
- 28 Nov 2019
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Investigating the Acceptability and Impact of the Mediterranean Diet and Intermittent Fasting
- ClinicalTrials.gov ID
- NCT04185948
- Acronym / sponsor ID
- HLS-JLG-2019
- Conditions
- Body Weight Changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- 19 Jan 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 27 Nov 2019 (actual)
- First posted
- 4 Dec 2019 (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.
This clinical trial attempts to evaluate the feasibility and acceptability of an intervention combining intermittent fasting and the Mediterranean diet guidelines vs an comparative intervention combining intermittent fasting but using the UK dietary guidelines.
Participants will be randomised to these intervention using a parallel design. Weight change and blood lipids will be assessed.
Detailed description
This study will have a randomised parallel study comparing two interventions involving intermittent fasting. One of the interventions will use the Mediterranean dietary guidelines proposed by the Mediterranean Diet Foundation, the other intervention will use the UK dietary guidelines (Eatwell Guide).
In this study, the interventions will require participants to adopt these interventions for 4 weeks. A basic website containing support information will be develop for each of these interventions.
Baseline measurements will be taken at the start of the study. Blood samples will be obtained in a fasted state before and after 4-week study period.
Anthropometric and body composition measurements including height and weight, waist circumference, bioelectrical impedance will be collected by researcher. Physical activity will be assessed using accelerometers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mediterranean diet plus intermittent fasting | Experimental | Behavioral: Mediterranean diet guidelines plus intermittent fastingFor 4 weeks participants will be encouraged to adopt the Mediterranean dietary guidelines as recommended by the Mediterranean Diet Foundation in Barcelona, Spain. In combination with these guidelines, an intermittent fasting regime involving two days of the week will be implemented. The regime will encourage individuals to consume of 500kcal per day for women and 625kcal per day for men, resulting in 75% daily caloric restriction during each of these two days. |
| Eatwell guide plus intermittent fasting | Active comparator | Behavioral: UK Eatwell guidelines plus intermittent fastingFor 4 weeks participants will be encouraged to adopt the UK dietary guidelines (Eatwell Guide). In combination with these guidelines, an intermittent fasting regime involving two days of the week will be implemented. The regime will encourage individuals to consume of 500kcal per day for women and 625kcal per day for men, resulting in 75% daily caloric restriction during each of these two days. |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 18-70 yrs BMI 25-39.9kg/m2, Able to attend university for measurement and educational sessions.
Key exclusion criteria (14 listed)
- Cardiovascular problems or documented history of CVD including: angina; myocardial infarction; coronary revascularization procedures; stroke (ischemic or haemorrhagic, including transient ischemic attacks) symptomatic peripheral artery disease that required surgery or was diagnosed with vascular imaging techniques; ventricular arrhythmia; uncontrolled atrial fibrillation; congestive heart failure; hypertrophic myocardiopathy, or aortic aneurism,
- Active malignant cancer or history of malignancy within the last 5 years (except non-melanoma skin cancer)
- Issues affecting food intake e.g. dysphagia, severe allergies, food neophobia, strong dislike of foods in diet plan, or religious issues
- Lack of motivation to change diet/lifestyle (low likelihood as calculated according to the Prochaska and DiClemente Stages of Change Model)
- Lack of motivation to fast Medical reasons not allowing very low calorie intake, type 1 or 2 diabetes
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 |
|---|---|---|
| Mediterranean diet guidelines plus intermittent fastingFor 4 weeks participants will be encouraged to adopt the Mediterranean dietary guidelines as recommended by the Mediterranean Diet Foundation in Barcelona, Spain. In combination with these guidelines, an intermittent fasting regime involving two days of the week will be implemented. The regime will encourage individuals to consume of 500kcal per day for women and 625kcal per day for men, resulting in 75% daily caloric restriction during each of these two days. | Behavioural | Mediterranean diet plus intermittent fasting |
| UK Eatwell guidelines plus intermittent fastingFor 4 weeks participants will be encouraged to adopt the UK dietary guidelines (Eatwell Guide). In combination with these guidelines, an intermittent fasting regime involving two days of the week will be implemented. The regime will encourage individuals to consume of 500kcal per day for women and 625kcal per day for men, resulting in 75% daily caloric restriction during each of these two days. | Behavioural | Eatwell guide plus intermittent fasting |
Primary outcome
Feasibility and acceptability of intervention
Time frame: 4 weeks
Participants will complete a questionnaire directed to obtain early markers of how the intervention is used
4 secondary outcomes
Total cholesterol
Time frame: 4 weeks
Weight change
Time frame: 4 weeks
Change from baseline dietary intake
Time frame: 4 weeks
Change from baseline physical activity levels at 2 months
Time frame: 4 weeks
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 4 Dec 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean diet guidelines plus intermittent fasting and UK Eatwell guidelines plus intermittent fasting in people with Body Weight Changes, run by Northumbria University 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 1 inclusion and 14 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 4 Dec 2019. 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. 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?
Feasibility and acceptability of intervention (time frame: 4 weeks). 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 4 Dec 2019.