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

NCT04185948 | Completed

• 1 other identifier: HLS-JLG-2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. Participants will be randomised to these intervention using a parallel design. Weight change and blood lipids will be assessed.

Conditions

Body Weight Changes

Outcome Measures

Primary Outcomes (1)

• Feasibility and acceptability of intervention

  Participants will complete a questionnaire directed to obtain early markers of how the intervention is used

  4 weeks

Secondary Outcomes (4)

• Total cholesterol

  4 weeks

• Weight change

  4 weeks

• Change from baseline dietary intake

  4 weeks

• Change from baseline physical activity levels at 2 months

  4 weeks

Study Arms (2)

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.

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.

Behavioral: UK Eatwell guidelines plus intermittent fasting

Interventions

Mediterranean diet guidelines plus intermittent fasting BEHAVIORAL

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.

Mediterranean diet plus intermittent fasting

UK Eatwell guidelines plus intermittent fasting BEHAVIORAL

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.

Eatwell guide plus intermittent fasting

Eligibility Criteria

• Age: 10 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-70 yrs BMI 25-39.9kg/m2, Able to attend university for measurement and educational sessions.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northumbria University: lead

Study Sites (1)

Department of Applied Sciences, Faculty of Health and Life Sciences, Northumbria University

Newcastle upon Tyne, NE1 8ST, United Kingdom

Location

MeSH Terms

Conditions

Body Weight Changes

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 4, 2019
• Study Start: January 19, 2019
• Primary Completion: August 31, 2019
• Study Completion: November 27, 2019
• Last Updated: December 4, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)