Metabolic Effects of Plant-based Diet

Metabolic Effects of Plant-based Diet on Healthy Young Adults

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

Study Overview

• Status: Completed
• Conditions: Fatty Liver; Metabolic Syndrome; Insulin Resistance; Healthy Diet; Healthy Lifestyle; Healthy Nutrition
• Intervention / Treatment: Dietary supplement: Omnivore; Dietary supplement: Vegetarian; Dietary supplement: Vegan

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34010
    • Koç University Medical Faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control Group; 20 healthy individual will be in the control group. Participants of control group will not change their diet and will continue omnivore diet.	Dietary supplement: Omnivore; This study will evaluate effects of plant based diets (vegan and vegetarian). 60 omnivore individuals will be included. 20 of the participants will continue their omnivore diet as control group. 20 of the participants will change their diet to vegetarian, and 20 of them will change their diet to vegan.; Other Names: Control Group
Other: 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.	Dietary supplement: Vegetarian; 20 of the participants will change their diet to vegetarian diet. In this group participants will not eat any meat or meat product but can eat/drink milk products, egg and other animal products.
Other: 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.	Dietary supplement: Vegan; 20 of the participants will change their diet to vegan diet. In this group participants will not eat any kind of animal products.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Koç University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: April 22, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: plant-based; metabolic; fatty-liver
• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Liver Diseases; Hyperinsulinism; Fatty Liver; Metabolic Syndrome; Insulin Resistance
• Other Study ID Numbers: 28041993

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No