Metabolic Effects of Plant-based Diet

Not Applicable

Completed

• Conditions: Insulin Resistance; Fatty Liver; Metabolic Syndrome; Healthy Lifestyle; Healthy Diet; Healthy Nutrition
• Interventions: Dietary Supplement: Vegan; Dietary Supplement: Vegetarian; Dietary Supplement: Omnivore

• Registration Number: NCT05351853
• Lead Sponsor: Koç University

Brief Summary

The purpose of this study is to assess the metabolic effects of plant based diet on healthy young adults.

Detailed Description

An internet announcement will be made and 60 participants who meet the eligibility requirements will be randomly selected. After being informed about study, all participants (60 omnivores) giving written informed consent will be assigned to the vegan and vegetarian groups of the study according to their preferences, while 20 participants will continue to be omnivores as the control group. At week 0 and 24, blood samples, urine samples, proton density fat fraction MRI evaluations and body composition analyze will be completed.

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2022-04-22
• Study First Posted: 2022-04-28
• Primary Completion: 2022-07-30
• Study Completion: 2022-07-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-12
• Last Update Posted: 2022-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Being 18-40 years old,
2. BMI is 18-30 kg/m2,
3. Having no chronic diseases,
4. Not smoking

Exclusion Criteria

1. Having chronic disease,
2. Being older than 40 years old or younger than 18 years old,
3. Smoking,
4. Alcoholism or drinking more than 140 gr/week of alcohol,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vegan	Vegan	20 healthy individual will be in the control group. Participants of this group will change their diet from omnivore to vegan (%100 plant based) after the beginning of the study.
Vegetarian	Vegetarian	20 healthy individual will be in the control group. Participants of this group will change their diet from omnivore to vegetarian (no meat /meat products) after the beginning of the study.
Control Group	Omnivore	20 healthy individual will be in the control group. Participants of control group will not change their diet and will continue omnivore diet.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Liver Steatosis at 6 months	At week 24 liver steatosis change will be compared between the groups.	Liver steatosis change will be compared between groups at the end of the study.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Insulin Resistance at 6 months	At week 24 insulin resistance change will be compared between the groups.	Insulin resistance change will be compared between groups at the end of the study.

Trial Locations

Locations (1)

Koc University Medical Faculty; 🇹🇷 Istanbul, Turkey