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

Blood Pressure Clinical Trial

— FlexiFast  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05762263
• Other study ID #: 2021/41/N/NZ9/01129
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 2023

Study information

• Verified date: November 2023
• Source: University of Warmia and Mazury in Olsztyn
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 96
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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).

Locations

Country	Name	City	State
Poland	University of Warmia and Mazury in Olsztyn	Olsztyn

Sponsors (1)

Lead Sponsor	Collaborator
University of Warmia and Mazury in Olsztyn

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in sleep length	Measured using smartbands with sleep trackers: length (in hours)	baseline, after 8 weeks and after 20 weeks from baseline
Other	Change in sleep quality	Measured using smartbands with sleep trackers: with metrics specific to the selected model (score).	baseline, after 8 weeks and after 20 weeks from baseline
Other	Change in cardiorespiratory fitness	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.	baseline, after 8 weeks and after 20 weeks from baseline
Other	Change in physical activity level	Measured using smartbands with pedometers (number of daily steps)	baseline, after 8 weeks and after 20 weeks from baseline
Other	Participant's satisfaction with treatment upon completion	Satisfaction with treatment: DSat-28 questionnaire (10.1002/osp4.299)	after 8 weeks
Other	Change in dietary behaviours	Dietary habits will be assessed using KomPAN questionnaire (https://doi.org/10.3390/nu10121845)	baseline, after 8 weeks and after 20 weeks from baseline
Primary	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.	baseline, after 8 weeks and after 20 weeks from baseline
Secondary	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.	baseline, after 8 weeks and after 20 weeks from baseline
Secondary	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.	baseline, after 8 weeks and after 20 weeks from baseline
Secondary	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.	baseline, after 8 weeks and after 20 weeks from baseline
Secondary	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.	baseline, after 8 weeks and after 20 weeks from baseline
Secondary	Change in body weight	Body weight (in kg) will be measured using a digital medical scale witl stadiometer.	baseline, after 8 weeks and after 20 weeks from baseline
Secondary	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).	baseline, after 8 weeks and after 20 weeks from baseline
Secondary	Change in body fat mass percentage	Determination of body fat percentage will be performed using SECA® mBCA 515 analyser	baseline, after 8 weeks and after 20 weeks from baseline
Secondary	Change in waist circumference	Waist circumference measuring (in cm) will be performed using a non-strechable measuring tape.	baseline, after 8 weeks and after 20 weeks from baseline
Secondary	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).	baseline, after 8 weeks and after 20 weeks from baseline
Secondary	Change in visceral adipose tissue (VAT)	Determination of abdominal fat volume will be measured in litres and performed using SECA® mBCA 515 analyser	baseline, after 8 weeks and after 20 weeks from baseline
Secondary	Change in inflammatory markers-1	interleukin-6 [pg/mL] - COBAS e411 analyser	baseline, after 8 weeks and after 20 weeks from baseline
Secondary	Change in inflammatory markers-2	C-reactive protein (CRP) [mg/L] - COBAS Integra 400 Plus analyser	baseline, after 8 weeks and after 20 weeks from baseline
Secondary	Change in nutrition markers-1	Homocysteine [µmol/L] - COBAS Integra 400 Plus analyser	baseline, after 8 weeks and after 20 weeks from baseline
Secondary	Change in nutrition markers-2	Vitamin B12 [pg/mL] - COBAS e411 analyser	baseline, after 8 weeks and after 20 weeks from baseline
Secondary	Change in insulin concentration	Insulin [units/mL] - COBAS e411 analyser	baseline, after 8 weeks and after 20 weeks from baseline
Secondary	Change in haemoglobin glycosylated (HbA1c) concentration	HbA1c [mmol/l] - COBAS e411 analyser	baseline, after 8 weeks and after 20 weeks from baseline
Secondary	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).	baseline, after 8 weeks and after 20 weeks from baseline