NCT04185948

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Northumbria University · Academic / Other
• Sex: All
• Age: 10 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Body Weight Changes

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2019-01-19
• Primary completion: 2019-08-31
• Completion: 2019-11-27
• First posted: 2019-12-04
• Last updated: 2019-12-04

Locations

1 site across 1 country: United Kingdom