Pilot Study on the Impact of the Mediterranean Diet and Intermittent Fasting

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Study Investigating the Acceptability and Impact of the Mediterranean Diet and Intermittent Fasting

Conditions
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Body Weight Changes

Intervention / Treatment
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* Behavioral: Mediterranean diet guidelines plus intermittent fasting
* Behavioral: UK Eatwell guidelines plus intermittent fasting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-70 yrs BMI 25-39.9kg/m2, Able to attend university for measurement and educational sessions. Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mediterranean diet plus intermittent fasting<br>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. | Behavioral: Mediterranean diet guidelines plus intermittent fasting<br>* 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.<br>|
| Active Comparator: Eatwell guide plus intermittent fasting<br>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. | Behavioral: UK Eatwell guidelines plus intermittent fasting<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility and acceptability of intervention | Participants will complete a questionnaire directed to obtain early markers of how the intervention is used | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol | Plasma levels of total cholesterol | 4 weeks | 
| Weight change | Weight change after intervention | 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. | 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. | 4 weeks |