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

Primary Purpose

Body Weight Changes

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Mediterranean diet guidelines plus intermittent fasting
UK Eatwell guidelines plus intermittent fasting
Sponsored by
Northumbria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Body Weight Changes

Eligibility Criteria

10 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mediterranean diet plus intermittent fasting

Eatwell guide plus intermittent fasting

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Total cholesterol
Plasma levels of total cholesterol
Weight change
Weight change after intervention
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.
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.

Full Information

First Posted
November 28, 2019
Last Updated
December 2, 2019
Sponsor
Northumbria University
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1. Study Identification

Unique Protocol Identification Number
NCT04185948
Brief Title
Pilot Study on the Impact of the Mediterranean Diet and Intermittent Fasting
Official Title
A Pilot Study Investigating the Acceptability and Impact of the Mediterranean Diet and Intermittent Fasting
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 19, 2019 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
November 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northumbria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight Changes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mediterranean diet plus intermittent fasting
Arm Type
Experimental
Arm Description
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.
Arm Title
Eatwell guide plus intermittent fasting
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mediterranean diet guidelines plus intermittent fasting
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
UK Eatwell guidelines plus intermittent fasting
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility and acceptability of intervention
Description
Participants will complete a questionnaire directed to obtain early markers of how the intervention is used
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Total cholesterol
Description
Plasma levels of total cholesterol
Time Frame
4 weeks
Title
Weight change
Description
Weight change after intervention
Time Frame
4 weeks
Title
Change from baseline dietary intake
Description
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.
Time Frame
4 weeks
Title
Change from baseline physical activity levels at 2 months
Description
Physical activity will be assessed assessed during seven days at baseline and after 2 months interventions by accelerometry.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Applied Sciences, Faculty of Health and Life Sciences, Northumbria University
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 8ST
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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

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