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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
96
Depending on the allocation arm, participants will be advised to follow a particular dietary plan (either flexitarian eating, time-restricted eating or both combined).
University of Warmia and Mazury in Olsztyn
Olsztyn, Poland
Change in glucose homeostasis
Change in fasting glucose concentration \[mg/dL\]. Blood samples will be collected after the overnight fast and the analysis will be performed on the Cobas Integra 400 plus analyzer.
Time frame: baseline, after 8 weeks and after 20 weeks from baseline
Change in total cholesterol (TC)
The blood serum concentration of total cholesterol (in mmol/L). Blood samples will be collected after the overnight fast and the analysis will be performed on the Cobas Integra 400 plus analyzer.
Time frame: baseline, after 8 weeks and after 20 weeks from baseline
Change in high-density lipoprotein (HDL) cholesterol
The blood serum concentration of high-density lipoprotein cholesterol (in mmol/L). Blood samples will be collected after the overnight fast and the analysis will be performed on the Cobas Integra 400 plus analyzer.
Time frame: baseline, after 8 weeks and after 20 weeks from baseline
Change in low-density lipoprotein (LDL) cholesterol
The blood serum concentration of low-density lipoprotein cholesterol (in mmol/L). Blood samples will be collected after the overnight fast and the analysis will be performed on Cobas Integra 400 plus analyzer.
Time frame: baseline, after 8 weeks and after 20 weeks from baseline
Change in serum triglycerides (TG)
The concentration of serum triglycerides (in mmol/L). Blood samples will be collected after the overnight fast and the analysis will be performed on Cobas Integra 400 plus analyzer.
Time frame: baseline, after 8 weeks and after 20 weeks from baseline
Change in body weight
Body weight (in kg) will be measured using a digital medical scale witl stadiometer.
Time frame: baseline, after 8 weeks and after 20 weeks from baseline
Change in body mass index (BMI)
The measured values of body height and weight will be used for the calculation of body mass index (in kg/m\^2).
Time frame: baseline, after 8 weeks and after 20 weeks from baseline
Change in body fat mass percentage
Determination of body fat percentage will be performed using SECA® mBCA 515 analyser
Time frame: baseline, after 8 weeks and after 20 weeks from baseline
Change in waist circumference
Waist circumference measuring (in cm) will be performed using a non-strechable measuring tape.
Time frame: baseline, after 8 weeks and after 20 weeks from baseline
Change in waist-to-hip ratio
The waist-to-hip ratio will be calculated from the measured values of waist and hip circumferences: waist circumference (cm) / hip circumference (cm).
Time frame: baseline, after 8 weeks and after 20 weeks from baseline
Change in visceral adipose tissue (VAT)
Determination of abdominal fat volume will be measured in litres and performed using SECA® mBCA 515 analyser
Time frame: baseline, after 8 weeks and after 20 weeks from baseline
Change in inflammatory markers-1
interleukin-6 \[pg/mL\] - COBAS e411 analyser
Time frame: baseline, after 8 weeks and after 20 weeks from baseline
Change in inflammatory markers-2
C-reactive protein (CRP) \[mg/L\] - COBAS Integra 400 Plus analyser
Time frame: baseline, after 8 weeks and after 20 weeks from baseline
Change in nutrition markers-1
Homocysteine \[μmol/L\] - COBAS Integra 400 Plus analyser
Time frame: baseline, after 8 weeks and after 20 weeks from baseline
Change in nutrition markers-2
Vitamin B12 \[pg/mL\] - COBAS e411 analyser
Time frame: baseline, after 8 weeks and after 20 weeks from baseline
Change in insulin concentration
Insulin \[units/mL\] - COBAS e411 analyser
Time frame: baseline, after 8 weeks and after 20 weeks from baseline
Change in haemoglobin glycosylated (HbA1c) concentration
HbA1c \[mmol/l\] - COBAS e411 analyser
Time frame: baseline, after 8 weeks and after 20 weeks from baseline
Change in systolic and diastolic blood pressure
The assessment of blood pressure (in mmHg) will be performed prior to and immediately after the intervention using electronic monitor (Omron M3 Intellisense Automatic Blood Monitor, Omron Healthcare, Mannheim, Germany).
Time frame: baseline, after 8 weeks and after 20 weeks from baseline
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