Back to resultsMetabolic Effects of Plant-based Diet
Primary Purpose
Healthy Diet, Fatty Liver, Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Omnivore
Vegetarian
Vegan
Sponsored by
About this trial
This is an interventional other trial for Healthy Diet focused on measuring plant-based, metabolic, fatty-liver
Eligibility Criteria
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,
Sites / Locations
- Koc University Medical Faculty
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Control Group
Vegetarian
Vegan
Arm Description
20 healthy individual will be in the control group. Participants of control group will not change their diet and will continue omnivore diet.
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.
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.
Outcomes
Primary Outcome Measures
Change from Baseline Liver Steatosis at 6 months
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
Insulin resistance change will be compared between groups at the end of the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05351853
Brief Title
Metabolic Effects of Plant-based Diet
Official Title
Metabolic Effects of Plant-based Diet on Healthy Young Adults
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Koç University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the metabolic effects of plant based diet on healthy young adults.
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 24, blood samples, urine samples, proton density fat fraction MRI evaluations and body composition analyze will be completed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Diet, Fatty Liver, Insulin Resistance, Metabolic Syndrome, Healthy Lifestyle, Healthy Nutrition
Keywords
plant-based, metabolic, fatty-liver
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Other
Arm Description
20 healthy individual will be in the control group. Participants of control group will not change their diet and will continue omnivore diet.
Arm Title
Vegetarian
Arm Type
Other
Arm Description
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.
Arm Title
Vegan
Arm Type
Other
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omnivore
Other Intervention Name(s)
Control Group
Intervention Description
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
Intervention Name(s)
Vegetarian
Intervention Description
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
Intervention Name(s)
Vegan
Intervention Description
20 of the participants will change their diet to vegan diet. In this group participants will not eat any kind of animal products.
Primary Outcome Measure Information:
Title
Change from Baseline Liver Steatosis at 6 months
Description
Liver steatosis change will be compared between groups at the end of the study.
Time Frame
At week 24 liver steatosis change will be compared between the groups.
Secondary Outcome Measure Information:
Title
Change from Baseline Insulin Resistance at 6 months
Description
Insulin resistance change will be compared between groups at the end of the study.
Time Frame
At week 24 insulin resistance change will be compared between the groups.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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,
Facility Information:
Facility Name
Koc University Medical Faculty
City
Istanbul
ZIP/Postal Code
34010
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Metabolic Effects of Plant-based Diet
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