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

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.

Study Overview

• Status: Completed
• Conditions: Body Weight Changes
• Intervention / Treatment: Behavioral: Mediterranean diet guidelines plus intermittent fasting; Behavioral: UK Eatwell guidelines plus intermittent fasting

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Newcastle upon Tyne, United Kingdom, NE1 8ST
    • Department of Applied Sciences, Faculty of Health and Life Sciences, Northumbria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mediterranean diet plus intermittent fasting; 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; 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.
Active Comparator: Eatwell guide plus intermittent fasting; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Northumbria University

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2019
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): November 27, 2019

Study Registration Dates

• First Submitted: November 28, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): December 4, 2019
• Last Update Submitted That Met QC Criteria: December 2, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes
• Other Study ID Numbers: HLS-JLG-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No