Metabolic Effects of Plant-based Diet

NCT ID: NCT05351853

Last Updated: 2022-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-07-30

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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Omnivore

Intervention Type DIETARY_SUPPLEMENT

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 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.

Group Type OTHER

Vegetarian

Intervention Type DIETARY_SUPPLEMENT

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 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.

Group Type OTHER

Vegan

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Control Group

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Koç University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Koc University Medical Faculty

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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28041993

Identifier Type: -

Identifier Source: org_study_id

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