Clinical trial NCT05762263: The Effect of Flexitarian, Time-restricted Eating on Cardiometabolic Traits in Normal Weight, Young Men
Official title: The Effect of Flexitarian, Time-restricted Eating on Cardiometabolic Traits in Normal Weight, Young Men: a Factorial Randomized Controlled Trial (FlexiFast Study)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiometabolic Syndrome
Glucose Metabolism Disorders
Blood Pressure
Lipid Metabolism Disorders
Lead sponsor: University of Warmia and Mazury in Olsztyn
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 96
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in glucose homeostasis
timeFrame: baseline, after 8 weeks and after 20 weeks from baseline
Secondary outcomes:
measure: Change in total cholesterol (TC)
timeFrame: baseline, after 8 weeks and after 20 weeks from baseline
measure: Change in high-density lipoprotein (HDL) cholesterol
timeFrame: baseline, after 8 weeks and after 20 weeks from baseline
measure: Change in low-density lipoprotein (LDL) cholesterol
timeFrame: baseline, after 8 weeks and after 20 weeks from baseline
measure: Change in serum triglycerides (TG)
timeFrame: baseline, after 8 weeks and after 20 weeks from baseline
measure: Change in body weight
timeFrame: baseline, after 8 weeks and after 20 weeks from baseline
measure: Change in body mass index (BMI)
timeFrame: baseline, after 8 weeks and after 20 weeks from baseline
measure: Change in body fat mass percentage
timeFrame: baseline, after 8 weeks and after 20 weeks from baseline
measure: Change in waist circumference
timeFrame: baseline, after 8 weeks and after 20 weeks from baseline
measure: Change in waist-to-hip ratio
timeFrame: baseline, after 8 weeks and after 20 weeks from baseline
measure: Change in visceral adipose tissue (VAT)
timeFrame: baseline, after 8 weeks and after 20 weeks from baseline
measure: Change in inflammatory markers-1
timeFrame: baseline, after 8 weeks and after 20 weeks from baseline
measure: Change in inflammatory markers-2
timeFrame: baseline, after 8 weeks and after 20 weeks from baseline
measure: Change in nutrition markers-1
timeFrame: baseline, after 8 weeks and after 20 weeks from baseline
measure: Change in nutrition markers-2
timeFrame: baseline, after 8 weeks and after 20 weeks from baseline
measure: Change in insulin concentration
timeFrame: baseline, after 8 weeks and after 20 weeks from baseline
measure: Change in haemoglobin glycosylated (HbA1c) concentration
timeFrame: baseline, after 8 weeks and after 20 weeks from baseline
measure: Change in systolic and diastolic blood pressure
timeFrame: baseline, after 8 weeks and after 20 weeks from baseline
Other outcomes:
measure: Change in sleep length
timeFrame: baseline, after 8 weeks and after 20 weeks from baseline
measure: Change in sleep quality
timeFrame: baseline, after 8 weeks and after 20 weeks from baseline
measure: Change in cardiorespiratory fitness
timeFrame: baseline, after 8 weeks and after 20 weeks from baseline
measure: Change in physical activity level
timeFrame: baseline, after 8 weeks and after 20 weeks from baseline
measure: Participant's satisfaction with treatment upon completion
timeFrame: after 8 weeks
measure: Change in dietary behaviours
timeFrame: baseline, after 8 weeks and after 20 weeks from baseline
Locations:
city: Olsztyn
country: Poland
facility: University of Warmia and Mazury in Olsztyn
Study officials:
affiliation: University of Warmia and Mazury in Olsztyn
name: Marta Lonnie, MSc
role: PRINCIPAL_INVESTIGATOR
References: