Metabolic Effects of Plant-based Diet

Sponsor

Koç University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05351853

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Diet Fatty Liver Insulin Resistance Metabolic Syndrome Healthy Lifestyle Healthy Nutrition	Dietary Supplement: Omnivore Dietary Supplement: Vegetarian Dietary Supplement: Vegan	N/A

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 12, blood samples, urine samples, proton density fat fraction MRI evaluations and body composition analyze will be completed.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Metabolic Effects of Plant-based Diet on Healthy Young Adults

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Jul 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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. and at the end of it.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Being 18-40 years old,
BMI is 18-30 kg/m2,
Having no chronic diseases,
Not smoking

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Koc University Medical Faculty	Istanbul		Turkey	34010

Sponsors and Collaborators

Koç University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Koç University

ClinicalTrials.gov Identifier:

NCT05351853

Other Study ID Numbers:

28041993

First Posted:

Apr 28, 2022

Last Update Posted:

Apr 28, 2022

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Koç University

plant-based

metabolic

fatty-liver

Additional relevant MeSH terms:

Fatty Liver

Metabolic Syndrome

Insulin Resistance

Study Results

No Results Posted as of Apr 28, 2022