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Cardiometabolic SyndromeFlexiFastNCT05762263

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

A study testing Dietary in people with Cardiometabolic Syndrome and Glucose Metabolism Disorders, run by University of Warmia and Mazury in Olsztyn at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 40 years, men onlyHealthy volunteers can take part
What is being tested?
Dietary
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 sitePoland
Study dates
1 Apr 2023to Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • Females
  • Age <18 and >40 years
  • Overweight or obesity (BMI>25 kg/m2)
  • WC > 94cm
  • Alcohol >14 units/week
  • Smoking
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • University of Warmia and Mazury in Olsztyn

    Olsztyn, 10-719

Other trials in Poland

About this study

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

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.

Read more

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.

Being tested
Dietary
Medical subject headings
Metabolic Syndrome, Glucose Metabolism Disorders, Lipid Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DietaryBehavioural

    Depending on the allocation arm, participants will be advised to follow a particular dietary plan (either flexitarian eating, time-restricted eating or both combined).

Study groups in NCT05762263
Study groupRoleWhat they receive
Control groupNo interventionHabitual diet - healthy eating guidelines provided for ethical reasons, no restrictions on the time of eating
Flexitarian diet groupExperimentalFlexitarian 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.
Receives: Behavioral: Dietary
Time-restricted eating groupExperimentalTime 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;
Receives: Behavioral: Dietary
Flexitarian diet & time-restricted eating groupExperimentalTreatment TRE and FD combined.
Receives: Behavioral: Dietary

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline, after 8 weeks and after 20 weeks from baseline

Secondary outcomes (17)

  1. 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.

    Measured: baseline, after 8 weeks and after 20 weeks from baseline

  2. 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.

    Measured: baseline, after 8 weeks and after 20 weeks from baseline

  3. 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.

    Measured: baseline, after 8 weeks and after 20 weeks from baseline

  4. 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.

    Measured: baseline, after 8 weeks and after 20 weeks from baseline

  5. Change in body weight

    Body weight (in kg) will be measured using a digital medical scale witl stadiometer.

    Measured: baseline, after 8 weeks and after 20 weeks from baseline

  6. 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).

    Measured: baseline, after 8 weeks and after 20 weeks from baseline

  7. Change in body fat mass percentage

    Determination of body fat percentage will be performed using SECA® mBCA 515 analyser

    Measured: baseline, after 8 weeks and after 20 weeks from baseline

  8. Change in waist circumference

    Waist circumference measuring (in cm) will be performed using a non-strechable measuring tape.

    Measured: baseline, after 8 weeks and after 20 weeks from baseline

  9. 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).

    Measured: baseline, after 8 weeks and after 20 weeks from baseline

  10. Change in visceral adipose tissue (VAT)

    Determination of abdominal fat volume will be measured in litres and performed using SECA® mBCA 515 analyser

    Measured: baseline, after 8 weeks and after 20 weeks from baseline

  11. Change in inflammatory markers-1

    interleukin-6 [pg/mL] - COBAS e411 analyser

    Measured: baseline, after 8 weeks and after 20 weeks from baseline

  12. Change in inflammatory markers-2

    C-reactive protein (CRP) [mg/L] - COBAS Integra 400 Plus analyser

    Measured: baseline, after 8 weeks and after 20 weeks from baseline

  13. Change in nutrition markers-1

    Homocysteine [μmol/L] - COBAS Integra 400 Plus analyser

    Measured: baseline, after 8 weeks and after 20 weeks from baseline

  14. Change in nutrition markers-2

    Vitamin B12 [pg/mL] - COBAS e411 analyser

    Measured: baseline, after 8 weeks and after 20 weeks from baseline

  15. Change in insulin concentration

    Insulin [units/mL] - COBAS e411 analyser

    Measured: baseline, after 8 weeks and after 20 weeks from baseline

  16. Change in haemoglobin glycosylated (HbA1c) concentration

    HbA1c [mmol/l] - COBAS e411 analyser

    Measured: baseline, after 8 weeks and after 20 weeks from baseline

  17. 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).

    Measured: baseline, after 8 weeks and after 20 weeks from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2023
  2. Study start1 Apr 2023
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05762263
Sponsor's protocol ID
2021/41/N/NZ9/01129
Acronym
FlexiFast
Status last verified
Nov 2023
First submitted
21 Dec 2022
Last updated
7 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Dietary in people with Cardiometabolic Syndrome and Glucose Metabolism Disorders, run by University of Warmia and Mazury in Olsztyn at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in glucose homeostasis (time frame: baseline, after 8 weeks and after 20 weeks from baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05762263.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.

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