Clinical trial NCT04185948: 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
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight Changes
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility and acceptability of intervention
timeFrame: 4 weeks
Secondary outcomes:
measure: Total cholesterol
timeFrame: 4 weeks
measure: Weight change
timeFrame: 4 weeks
measure: Change from baseline dietary intake
timeFrame: 4 weeks
measure: Change from baseline physical activity levels at 2 months
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Department of Applied Sciences, Faculty of Health and Life Sciences, Northumbria University
Study officials:
References: