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

NCT ID: NCT05762263

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2023-12-31

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.

Conditions

Cardiometabolic Syndrome; Glucose Metabolism Disorders; Blood Pressure; Lipid Metabolism Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Flexitarian diet group

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.

Group Type: EXPERIMENTAL

Dietary

Intervention Type: BEHAVIORAL

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

Time-restricted eating group

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;

Group Type: EXPERIMENTAL

Dietary

Intervention Type: BEHAVIORAL

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

Flexitarian diet & time-restricted eating group

Treatment TRE and FD combined.

Group Type: EXPERIMENTAL

Dietary

Intervention Type: BEHAVIORAL

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

Interventions

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).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Warmia and Mazury in Olsztyn

OTHER

Sponsor Role: lead

Responsible Party

Marta Lonnie

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marta Lonnie, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Warmia and Mazury in Olsztyn

Locations

University of Warmia and Mazury in Olsztyn

Olsztyn, , Poland

Countries

Poland

Other Identifiers

2021/41/N/NZ9/01129

Identifier Type: -

Identifier Source: org_study_id