NCT05762263

The Effect of Flexitarian, Time-restricted Eating on Cardiometabolic Traits in Normal Weight, Young Men

The Effect of Flexitarian, Time-restricted Eating on Cardiometabolic Traits in Normal Weight, Young Men: a Factorial Randomized Controlled Trial (FlexiFast Study)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: University of Warmia and Mazury in Olsztyn · Academic / Other
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The goal of this factorial randomized controlled trial is to find out whether time-restricted eating and flexitarian diet (on its own and combined) can improve cardiometabolic health markers in normal weight, young men with metabolic abnormalities? Participants will be assigned to four groups: control, flexitarian, time-restricted eating and time-restricted eating + flexitarian. Investigators will look for men with elevated fasting blood glucose or blood lipids level or blood pressure and with normal body weight and waistline. Participants from the flexitarian group will be asked to follow a diet that has been carefully designed for them by the PI and dietitian for the period of 8 weeks. Participants from the control group will receive general healthy eating recommendations. We aim to investigate if the experiment had any effect on changes in metabolic, inflammation and nutritional markers, blood pressure and body weight and composition. Also, the effect of diets on men's sleep, general wellbeing and satisfaction with treatment will be investigated. The proposed study can test a potentially effective nutritional intervention which is feasible to adopt and sustainable (in line with recent planetary diet recommendations). Confirming its effectiveness can fill the research gap, providing new knowledge and approach to the prevention and treatment of metabolic abnormalities in young, lean men.

Conditions

• Cardiometabolic Syndrome
• Glucose Metabolism Disorders
• Blood Pressure
• Lipid Metabolism Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Dietary	Depending on the allocation arm, participants will be advised to follow a particular dietary plan (either flexitarian eating, time-restricted eating or both combined).

Timeline

• Start date: 2023-04-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2023-03-09
• Last updated: 2023-11-07

Locations

1 site across 1 country: Poland