Blood Pressure, Cardiometabolic Syndrome, Glucose Metabolism Disorders, Lipid Metabolism Disorders
Conditions
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.
Interventions
BEHAVIORALDietary
Depending on the allocation arm, participants will be advised to follow a particular dietary plan (either flexitarian eating, time-restricted eating or both combined).
Sponsors
University of Warmia and Mazury in Olsztyn
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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-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 nutrition markers-2 | baseline, after 8 weeks and after 20 weeks from baseline | Vitamin B12 \[pg/mL\] - COBAS e411 analyser |
| Change in insulin concentration | baseline, after 8 weeks and after 20 weeks from baseline | Insulin \[units/mL\] - 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 |
| 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 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 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 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 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 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 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 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 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 inflammatory markers-1 | baseline, after 8 weeks and after 20 weeks from baseline | interleukin-6 \[pg/mL\] - COBAS e411 analyser |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in cardiorespiratory fitness | baseline, after 8 weeks and after 20 weeks from baseline | Oxygen consumption (VO2) measured using ergospirometer CORTEX MetaMax 3b (ml oxygen/kg of body weight/minute). VO2 max is the maximum amount of oxygen the body can utilize during exercise. |
| Change in physical activity level | baseline, after 8 weeks and after 20 weeks from baseline | Measured using smartbands with pedometers (number of daily steps) |
| Participant's satisfaction with treatment upon completion | after 8 weeks | Satisfaction with treatment: DSat-28 questionnaire (10.1002/osp4.299) |
| Change in dietary behaviours | baseline, after 8 weeks and after 20 weeks from baseline | Dietary habits will be assessed using KomPAN questionnaire (https://doi.org/10.3390/nu10121845) |
| Change in sleep length | baseline, after 8 weeks and after 20 weeks from baseline | Measured using smartbands with sleep trackers: length (in hours) |
| Change in sleep quality | baseline, after 8 weeks and after 20 weeks from baseline | Measured using smartbands with sleep trackers: with metrics specific to the selected model (score). |
Countries
Poland
Outcome results
None listed