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Completed

NCT Number: NCT05351853

Metabolic Effects of Plant-based Diet

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

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Koc University Medical Faculty

Istanbul, 34010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Omnivore

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.

Other names: Control Group

Vegetarian

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

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.

Primary outcomes

  1. Change from Baseline Liver Steatosis at 6 months

    Time frame: 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 outcomes

  1. Change from Baseline Insulin Resistance at 6 months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Koç University

Other

Registry information

Official study title

Metabolic Effects of Plant-based Diet on Healthy Young Adults

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 28, 2022
Registry last updated
Oct 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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