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

University of Warmia and Mazury in Olsztyn

Status: Active, not recruiting

Conditions: Lipid Metabolism Disorders; Glucose Metabolism Disorders; Cardiometabolic Syndrome; Blood Pressure

Treatments: Behavioral: Dietary

Study type: Interventional

Funder types: Other

Identifiers

NCT05762263

2021/41/N/NZ9/01129

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males
• Age 18-40 years
• Normal body weight
• At least one of metabolic abnormalities (elevated fasting glucose level - but not diabetes, elevated blood lipids, elevated blood pressure)

Exclusion criteria

• Females
• Age <18 and >40 years
• Overweight or obesity (BMI>25 kg/m2)
• WC > 94cm
• Alcohol >14 units/week
• Smoking
• On medication
• Diabetes or other chronic diseases
• Vegetarians or vegans
• Don't own or unable to use a Smartphone with Apple iOS or Android OS

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

96 participants in 4 patient groups

Control group

No Intervention group

Description:

Habitual diet - healthy eating guidelines provided for ethical reasons, no restrictions on the time of eating

Flexitarian diet group

Experimental group

Description:

Flexitarian diet (FD) will be based on planetary diet recommendations (predominantly plants; pulses and legumes as protein sources, meat and poultry consumed occasionally). Ways to facilitate this diet will be presented in the booklet prepared for them by the PI and a dietitian.

Treatment:

Behavioral: Dietary

Time-restricted eating group

Experimental group

Description:

Time restricted eating (TRE) with 6 hour eating window - start and end hour to be an individual choice (some may prefer to consume their meals within an early window, e.g. 10am-4pm, some may prefer to consume their meals later in the day, e.g. 12:00-6pm). However, participants will be asked to be fairly consistent with their choice of their timing of eating hours. During fasting only water will be permitted;

Treatment:

Behavioral: Dietary

Flexitarian diet & time-restricted eating group

Experimental group

Description:

Treatment TRE and FD combined.

Treatment:

Behavioral: Dietary