Healthy DietNCT05351853
Metabolic Effects of Plant-based Diet
A study testing Omnivore, Vegetarian and Vegan in people with Healthy Diet and Fatty Liver, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to assess the metabolic effects of plant based diet on healthy young adults. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Diet, Fatty Liver, Insulin Resistance
- What is being tested?
- Omnivore, Vegetarian and Vegan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2021to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being 18-40 years old,
- BMI is 18-30 kg/m2,
- Having no chronic diseases,
- Not smoking
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Koc University Medical Faculty
Istanbul, 34010
About this study
Official title: Metabolic Effects of Plant-based Diet on Healthy Young Adults
The purpose of this study is to assess the metabolic effects of plant based diet on healthy young adults.
Read the 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.
- Conditions
- Healthy Diet, Fatty Liver, Insulin Resistance, Metabolic Syndrome, Healthy Lifestyle, Healthy Nutrition
- Being tested
- Omnivore, Vegetarian, Vegan
- Keywords
- plant-based, metabolic, fatty-liver
- Medical subject headings
- Fatty Liver, Insulin Resistance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmnivoreDietary supplement
Also called Control Group
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.
VegetarianDietary 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.
VeganDietary supplement
20 of the participants will change their diet to vegan diet. In this group participants will not eat any kind of animal products.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Vegan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Liver Steatosis at 6 months
Liver steatosis change will be compared between groups at the end of the study.
Measured: At week 24 liver steatosis change will be compared between the groups.
Secondary outcomes (1)
Change from Baseline Insulin Resistance at 6 months
Insulin resistance change will be compared between groups at the end of the study.
Measured: At week 24 insulin resistance change will be compared between the groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 Oct 2021
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy DietStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351853
- Sponsor's protocol ID
- 28041993
- Status last verified
- Oct 2022
- First submitted
- 8 Dec 2021
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guler Senturk B, Gurses B, Soyturk C, Copur S, Incir S, Siriopol D, Hasbal NB, Akyildiz M, van Raalte DH, Kanbay M. Effects of plant-based diet on metabolic parameters, liver and kidney steatosis: a prospective interventional open-label study. Br J Nutr. 2025 Feb 14;133(3):289-298. doi: 10.1017/S0007114525000017. Epub 2025 Jan 10.
PubMed 39789792
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Plant-based Diet on Healthy Young Adults
- ClinicalTrials.gov ID
- NCT05351853
- Acronym / sponsor ID
- 28041993
- Conditions
- Healthy Diet, Fatty Liver, Insulin Resistance, Metabolic Syndrome, Healthy Lifestyle, Healthy Nutrition
- Keywords
- plant-based, metabolic, fatty-liver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Dietary Supplement: Omnivore20 healthy individual will be in the control group. Participants of control group will not change their diet and will continue omnivore diet. |
| Vegetarian | Other | Dietary Supplement: Vegetarian20 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. |
| Vegan | Other | Dietary Supplement: Vegan20 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being 18-40 years old,
- BMI is 18-30 kg/m2,
- Having no chronic diseases,
- Not smoking
Key exclusion criteria (4 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmnivoreAlso: Control GroupThis 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. | Dietary supplement | Control Group |
| Vegetarian20 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. | Dietary supplement | Vegetarian |
| Vegan20 of the participants will change their diet to vegan diet. In this group participants will not eat any kind of animal products. | Dietary supplement | Vegan |
Primary outcome
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.
1 secondary outcome
Change from Baseline Insulin Resistance at 6 months
Time frame: At week 24 insulin resistance change will be compared between the groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Derived from this study: PubMed 39789792Guler Senturk B, Gurses B, Soyturk C, Copur S, Incir S, Siriopol D, Hasbal NB, Akyildiz M, van Raalte DH, Kanbay M. Effects of plant-based diet on metabolic parameters, liver and kidney steatosis: a prospective interventional open-label study. Br J Nutr. 2025 Feb 14;133(3):289-298. doi: 10.1017/S0007114525000017. Epub 2025 Jan 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omnivore, Vegetarian and Vegan in people with Healthy Diet and Fatty Liver, run by Koç University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Liver Steatosis at 6 months (time frame: At week 24 liver steatosis change will be compared between the groups.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05351853, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.