Metabolic Effects of Plant-based Diet

NCT05351853 | Completed

• 1 other identifier: 28041993
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

plant-based; metabolic; fatty-liver

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from Baseline Insulin Resistance at 6 months

  At week 24 insulin resistance change will be compared between the groups.

Study Arms (3)

Control Group

OTHER

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

Vegetarian

OTHER

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

Vegan

OTHER

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

Interventions

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.

Also known as: Control Group

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.

Vegetarian

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.

Vegan

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koc University Medical Faculty

Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatty Liver; Insulin Resistance; Metabolic Syndrome

Interventions

Control Groups; Diet, Vegetarian; Diet, Vegan

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: April 28, 2022
• Study Start: October 1, 2021
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-10

Locations

TU (1)