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

NCT05762263 | Unknown

• 1 other identifier: 2021/41/N/NZ9/01129
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (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.

  baseline, after 8 weeks and after 20 weeks from baseline

Secondary Outcomes (17)

• Change in total cholesterol (TC)

  baseline, after 8 weeks and after 20 weeks from baseline

• Change in high-density lipoprotein (HDL) cholesterol

  baseline, after 8 weeks and after 20 weeks from baseline

• Change in low-density lipoprotein (LDL) cholesterol

  baseline, after 8 weeks and after 20 weeks from baseline

• Change in serum triglycerides (TG)

  baseline, after 8 weeks and after 20 weeks from baseline

• Change in body weight

  baseline, after 8 weeks and after 20 weeks from baseline

Other Outcomes (6)

• Change in sleep length

  baseline, after 8 weeks and after 20 weeks from baseline

• Change in sleep quality

  baseline, after 8 weeks and after 20 weeks from baseline

• Change in cardiorespiratory fitness

  baseline, after 8 weeks and after 20 weeks from baseline

Study Arms (4)

Control group

NO INTERVENTION

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

Flexitarian diet group

EXPERIMENTAL

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.

Behavioral: Dietary

Time-restricted eating group

EXPERIMENTAL

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;

Behavioral: Dietary

Flexitarian diet & time-restricted eating group

EXPERIMENTAL

Treatment TRE and FD combined.

Behavioral: Dietary

Interventions

Dietary 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; Flexitarian diet group; Time-restricted eating group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Warmia and Mazury in Olsztyn: lead

Study Sites (1)

University of Warmia and Mazury in Olsztyn

Olsztyn, 10-719, Poland

Location

MeSH Terms

Conditions

Metabolic Syndrome; Glucose Metabolism Disorders; Lipid Metabolism Disorders

Interventions

Diet

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Marta Lonnie, MSc

  University of Warmia and Mazury in Olsztyn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: March 9, 2023
• Study Start: April 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

PL (1)