Metabolic Effects of Plant-based Diet

Metabolic Syndrome Clinical Trial

Official title:

Metabolic Effects of Plant-based Diet on Healthy Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05351853
• Other study ID #: 28041993
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: October 2022
• Source: Koç University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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,

Related Conditions & MeSH terms

• Fatty Liver
• Healthy Diet
• Healthy Lifestyle
• Insulin Resistance
• Metabolic Syndrome

Intervention

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.
• 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.
• Vegan
20 of the participants will change their diet to vegan diet. In this group participants will not eat any kind of animal products.

Locations

Country	Name	City	State
Turkey	Koc University Medical Faculty	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Koç University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.