The Effect of Flexitarian, Time-restricted Eating on Cardiometabolic Traits in Normal Weight, Young Men
- Conditions
- Glucose Metabolism DisordersLipid Metabolism DisordersCardiometabolic SyndromeBlood Pressure
- Interventions
- Behavioral: Dietary
- Registration Number
- NCT05762263
- Lead Sponsor
- University of Warmia and Mazury in Olsztyn
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 96
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Flexitarian diet & time-restricted eating group Dietary Treatment TRE and FD combined. Flexitarian diet group Dietary 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. Time-restricted eating group Dietary 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;
- Primary Outcome Measures
Name Time Method Change in glucose homeostasis baseline, after 8 weeks and after 20 weeks from baseline 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.
- Secondary Outcome Measures
Name Time Method Change in waist circumference baseline, after 8 weeks and after 20 weeks from baseline Waist circumference measuring (in cm) will be performed using a non-strechable measuring tape.
Change in high-density lipoprotein (HDL) cholesterol baseline, after 8 weeks and after 20 weeks from baseline 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.
Change in insulin concentration baseline, after 8 weeks and after 20 weeks from baseline Insulin \[units/mL\] - COBAS e411 analyser
Change in body weight baseline, after 8 weeks and after 20 weeks from baseline Body weight (in kg) will be measured using a digital medical scale witl stadiometer.
Change in waist-to-hip ratio baseline, after 8 weeks and after 20 weeks from baseline The waist-to-hip ratio will be calculated from the measured values of waist and hip circumferences: waist circumference (cm) / hip circumference (cm).
Change in low-density lipoprotein (LDL) cholesterol baseline, after 8 weeks and after 20 weeks from baseline 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.
Change in serum triglycerides (TG) baseline, after 8 weeks and after 20 weeks from baseline 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.
Change in body mass index (BMI) baseline, after 8 weeks and after 20 weeks from baseline The measured values of body height and weight will be used for the calculation of body mass index (in kg/m\^2).
Change in body fat mass percentage baseline, after 8 weeks and after 20 weeks from baseline Determination of body fat percentage will be performed using SECA® mBCA 515 analyser
Change in inflammatory markers-1 baseline, after 8 weeks and after 20 weeks from baseline interleukin-6 \[pg/mL\] - COBAS e411 analyser
Change in inflammatory markers-2 baseline, after 8 weeks and after 20 weeks from baseline C-reactive protein (CRP) \[mg/L\] - COBAS Integra 400 Plus analyser
Change in nutrition markers-1 baseline, after 8 weeks and after 20 weeks from baseline Homocysteine \[μmol/L\] - COBAS Integra 400 Plus analyser
Change in total cholesterol (TC) baseline, after 8 weeks and after 20 weeks from baseline 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.
Change in visceral adipose tissue (VAT) baseline, after 8 weeks and after 20 weeks from baseline Determination of abdominal fat volume will be measured in litres and performed using SECA® mBCA 515 analyser
Change in systolic and diastolic blood pressure baseline, after 8 weeks and after 20 weeks from baseline 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).
Change in nutrition markers-2 baseline, after 8 weeks and after 20 weeks from baseline Vitamin B12 \[pg/mL\] - COBAS e411 analyser
Change in haemoglobin glycosylated (HbA1c) concentration baseline, after 8 weeks and after 20 weeks from baseline HbA1c \[mmol/l\] - COBAS e411 analyser
Trial Locations
- Locations (1)
University of Warmia and Mazury in Olsztyn
🇵🇱Olsztyn, Poland