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

Primary Purpose

Cardiometabolic Syndrome, Glucose Metabolism Disorders, Blood Pressure

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Dietary
Sponsored by
University of Warmia and Mazury in Olsztyn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiometabolic Syndrome

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Warmia and Mazury in OlsztynRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control group

Flexitarian diet group

Time-restricted eating group

Flexitarian diet & time-restricted eating group

Arm Description

Habitual diet - healthy eating guidelines provided for ethical reasons, no restrictions on the time of eating

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 (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;

Treatment TRE and FD combined.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Change in body weight
Body weight (in kg) will be measured using a digital medical scale witl stadiometer.
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).
Change in body fat mass percentage
Determination of body fat percentage will be performed using SECA® mBCA 515 analyser
Change in waist circumference
Waist circumference measuring (in cm) will be performed using a non-strechable measuring tape.
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).
Change in visceral adipose tissue (VAT)
Determination of abdominal fat volume will be measured in litres and performed using SECA® mBCA 515 analyser
Change in inflammatory markers-1
interleukin-6 [pg/mL] - COBAS e411 analyser
Change in inflammatory markers-2
C-reactive protein (CRP) [mg/L] - COBAS Integra 400 Plus analyser
Change in nutrition markers-1
Homocysteine [μmol/L] - COBAS Integra 400 Plus analyser
Change in nutrition markers-2
Vitamin B12 [pg/mL] - COBAS e411 analyser
Change in insulin concentration
Insulin [units/mL] - COBAS e411 analyser
Change in haemoglobin glycosylated (HbA1c) concentration
HbA1c [mmol/l] - COBAS e411 analyser
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).

Full Information

First Posted
December 21, 2022
Last Updated
May 8, 2023
Sponsor
University of Warmia and Mazury in Olsztyn
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1. Study Identification

Unique Protocol Identification Number
NCT05762263
Brief Title
The Effect of Flexitarian, Time-restricted Eating on Cardiometabolic Traits in Normal Weight, Young Men
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Warmia and Mazury in Olsztyn

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiometabolic Syndrome, Glucose Metabolism Disorders, Blood Pressure, Lipid Metabolism Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Habitual diet - healthy eating guidelines provided for ethical reasons, no restrictions on the time of eating
Arm Title
Flexitarian diet group
Arm Type
Experimental
Arm Description
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.
Arm Title
Time-restricted eating group
Arm Type
Experimental
Arm Description
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;
Arm Title
Flexitarian diet & time-restricted eating group
Arm Type
Experimental
Arm Description
Treatment TRE and FD combined.
Intervention Type
Behavioral
Intervention Name(s)
Dietary
Intervention Description
Depending on the allocation arm, participants will be advised to follow a particular dietary plan (either flexitarian eating, time-restricted eating or both combined).
Primary Outcome Measure Information:
Title
Change in glucose homeostasis
Description
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
Secondary Outcome Measure Information:
Title
Change in total cholesterol (TC)
Description
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
Title
Change in high-density lipoprotein (HDL) cholesterol
Description
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
Title
Change in low-density lipoprotein (LDL) cholesterol
Description
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
Title
Change in serum triglycerides (TG)
Description
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
Title
Change in body weight
Description
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
Title
Change in body mass index (BMI)
Description
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
Title
Change in body fat mass percentage
Description
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
Title
Change in waist circumference
Description
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
Title
Change in waist-to-hip ratio
Description
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
Title
Change in visceral adipose tissue (VAT)
Description
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
Title
Change in inflammatory markers-1
Description
interleukin-6 [pg/mL] - COBAS e411 analyser
Time Frame
baseline, after 8 weeks and after 20 weeks from baseline
Title
Change in inflammatory markers-2
Description
C-reactive protein (CRP) [mg/L] - COBAS Integra 400 Plus analyser
Time Frame
baseline, after 8 weeks and after 20 weeks from baseline
Title
Change in nutrition markers-1
Description
Homocysteine [μmol/L] - COBAS Integra 400 Plus analyser
Time Frame
baseline, after 8 weeks and after 20 weeks from baseline
Title
Change in nutrition markers-2
Description
Vitamin B12 [pg/mL] - COBAS e411 analyser
Time Frame
baseline, after 8 weeks and after 20 weeks from baseline
Title
Change in insulin concentration
Description
Insulin [units/mL] - COBAS e411 analyser
Time Frame
baseline, after 8 weeks and after 20 weeks from baseline
Title
Change in haemoglobin glycosylated (HbA1c) concentration
Description
HbA1c [mmol/l] - COBAS e411 analyser
Time Frame
baseline, after 8 weeks and after 20 weeks from baseline
Title
Change in systolic and diastolic blood pressure
Description
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
Other Pre-specified Outcome Measures:
Title
Change in sleep length
Description
Measured using smartbands with sleep trackers: length (in hours)
Time Frame
baseline, after 8 weeks and after 20 weeks from baseline
Title
Change in sleep quality
Description
Measured using smartbands with sleep trackers: with metrics specific to the selected model (score).
Time Frame
baseline, after 8 weeks and after 20 weeks from baseline
Title
Change in cardiorespiratory fitness
Description
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.
Time Frame
baseline, after 8 weeks and after 20 weeks from baseline
Title
Change in physical activity level
Description
Measured using smartbands with pedometers (number of daily steps)
Time Frame
baseline, after 8 weeks and after 20 weeks from baseline
Title
Participant's satisfaction with treatment upon completion
Description
Satisfaction with treatment: DSat-28 questionnaire (10.1002/osp4.299)
Time Frame
after 8 weeks
Title
Change in dietary behaviours
Description
Dietary habits will be assessed using KomPAN questionnaire (https://doi.org/10.3390/nu10121845)
Time Frame
baseline, after 8 weeks and after 20 weeks from baseline

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marta Lonnie, MSc
Phone
+48895245514
Email
marta.lonnie@uwm.edu.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Lonnie, MSc
Organizational Affiliation
University of Warmia and Mazury in Olsztyn
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Warmia and Mazury in Olsztyn
City
Olsztyn
ZIP/Postal Code
10-719
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Lonnie, MSc
Phone
48895245514
Email
marta.lonnie@uwm.edu.pl
First Name & Middle Initial & Last Name & Degree
Lidia Wadolowska, Professor

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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