Metabolic Effects of Plant-based Diet

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

Detailed Description
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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.

Official Title
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Metabolic Effects of Plant-based Diet on Healthy Young Adults

Conditions
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Healthy Diet, Fatty Liver, Insulin Resistance, Metabolic Syndrome, Healthy Lifestyle, Healthy Nutrition

Intervention / Treatment
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* Dietary Supplement: Omnivore
* Dietary Supplement: Vegetarian
* Dietary Supplement: Vegan


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control Group<br>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<br>* 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.<br>* Other names: Control Group;|
| Other: Vegetarian<br>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<br>* 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.<br>|
| Other: Vegan<br>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<br>* 20 of the participants will change their diet to vegan diet. In this group participants will not eat any kind of animal products.<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plant-based, metabolic, fatty-liver