NAFLD, Non-alcoholic Fatty Liver DiseasePhase 1BJNCT05909631
Comparing Effects of Beetroot Juice and Mediterranean Diet on Liver Enzymes and Sonography in Patients With NAFLD
A Phase 1 study testing Beetroot juice, Mediterranean diet alone (MeD) and Mediterranean diet with beet juice (BJ+MeD) in people with NAFLD, Non-alcoholic Fatty Liver Disease, run by Sulaimani Polytechnic University at 1 site in Iraq.
Trial summary
The goal of this clinical trial study is to investigate comparing Effects of Beetroot juice and Mediterranean diet on Liver Enzymes and Sonographic appearance in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD) The main question[s] it aims to answer are: 1. Beetroot juice has role in reduce Liver Enzymes 2. Read more about this study
- Who is it for?
- Ages 19 to 73 yearsHealthy volunteers can take part
- Conditions the study is for
- NAFLD, Non-alcoholic Fatty Liver Disease
- What is being tested?
- Beetroot juice, Mediterranean diet alone (MeD) and Mediterranean diet with beet juice (BJ+MeD)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteIraq
- Study dates
- 10 Jan 2023to 11 Apr 2023
- Phase
- Phase 1
- 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 19 to 73 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients had to be between the ages of 19 and 73, and they had to have NAFLD as their main diagnosis.
- For a NAFLD diagnosis, ultrasound proof of fatty liver (stage I or above) and an elevated level of liver enzymes were required.
Who cannot join
- history of diseases like cardiovascular, liver, chronic hepatitis C, and kidney disease
- supplement use within the previous six months; hormone therapy; use of drugs like amiodarone, methotrexate, and corticosteroids
- cases of starvation or inadequate nutrition; pregnancy; metabolic disorders like Wilson disease and glycogen storage disease; a history of liver irradiation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Effects of Beetroot Juice and Mediterranean Diet on Liver Enzymes and Sonography in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD): A Randomized Control Trials
The goal of this clinical trial study is to investigate comparing Effects of Beetroot juice and Mediterranean diet on Liver Enzymes and Sonographic appearance in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD)
The main question[s] it aims to answer are:
- Beetroot juice has role in reduce Liver Enzymes
- Mediterranean diet has role in reduce Liver Enzymes
Read the detailed description
Patients with NAFLD were identified and enrolled for this research at the PAR hospital in the Kurdistan Region of Iraq.
For 12 weeks, for the group members who were receiving the MeD, we recommended consuming Mediterranean foods like fish, poultry, sources of omega-3, vegetables and colored fruits, legumes and nuts, and low-fat goods while avoiding inflammatory foods like high-fat foods, processed meats, fast food, simple sugars, chips, and soft drinks.
At baseline, the participants' demographic and anthropometric information, including as gender, age, weight, height, smoking status, location of residence, and physical activity, were recorded.
- Conditions
- NAFLD, Non-alcoholic Fatty Liver Disease
- Being tested
- Beetroot juice, placebo, Mediterranean diet alone (MeD), Mediterranean diet with beet juice (BJ+MeD)
- Keywords
- Mediterranean diet, Beetroot juice, nonalcoholic fatty liver
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot juiceOther
250 ml of concentrated beetroot juice, were given to participants in the BJ groups .This was carried out in the morning, 30 minutes before breakfast, and on an empty stomach.
placeboOther
250 ml of a placebo
Mediterranean diet alone (MeD)Other
Mediterranean diet alone (MeD)
Mediterranean diet with beet juice (BJ+MeD)Combination product
Mediterranean diet with beet juice (BJ+MeD).
| Study group | Role | What they receive |
|---|---|---|
| 250 ml of a placebo | Placebo comparator | 250 ml of a placebo Receives: Other: placebo |
| beetroot juice (BJ) | Experimental | 250 ml of concentrated beetroot juice Receives: Other: Beetroot juice |
| Mediterranean diet with beet juice (BJ+MeD) | Experimental | Mediterranean diet with beet juice (BJ+MeD) Receives: Combination Product: Mediterranean diet with beet juice (BJ+MeD) |
| Mediterranean diet alone (MeD) | Experimental | Mediterranean diet alone (MeD) Receives: Other: Mediterranean diet alone (MeD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beetroot juice has role in reduce liver enzymes
Beetroot juice was given for 12 weeks and has role in reduce Serum Bilirubin, alkaline phosphatase (ALP), alanine transaminase (ALT), and liver enzyme was measured by blood sampling tests.
Measured: 12 weeks
Secondary outcomes (1)
Mediterranean diet contributes to lower liver enzyme levels.
Mediterranean diet was given for 12 weeks and has role in reduce Serum Bilirubin, alkaline phosphatase (ALP), alanine transaminase (ALT), and liver enzyme was measured by blood sampling tests.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start10 Jan 2023
- Primary completion20 Feb 2023
- Study completion11 Apr 2023
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 NAFLD, Non-alcoholic Fatty Liver DiseaseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants were split into four groups: control, Mediterranean diet with beet juice (BJ+MeD), Mediterranean diet alone (MeD) and beetroot juice (BJ). The Mediterranean diet included fruits, vegetables, fish, poultry, and other lean meats (without skin), sources of omega-3 fatty acids, nuts, and legumes. Beetroot juice had 250 mg of beetroot.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sulaimani Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hawal Lateef Fateh, Sulaimani Polytechnic University
- Investigators
- Hawal Lateef, Msc, Principal investigator, Nursing department, sulaimany polytechni university, kurdistan, iraq
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909631
- Sponsor's protocol ID
- KTC1212
- Acronym
- BJ
- Status last verified
- Jun 2023
- First submitted
- 10 May 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fateh HL, Rashid SA, Muhammad SS, Al-Jaf SH, Ali AM. Comparing effects of beetroot juice and Mediterranean diet on liver enzymes and sonographic appearance in patients with non-alcoholic fatty liver disease: a randomized control trials. Front Nutr. 2023 Aug 17;10:1181706. doi: 10.3389/fnut.2023.1181706. eCollection 2023.
PubMed 37662597
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Effects of Beetroot Juice and Mediterranean Diet on Liver Enzymes and Sonography in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD): A Randomized Control Trials
- ClinicalTrials.gov ID
- NCT05909631
- Acronym / sponsor ID
- BJ / KTC1212
- Conditions
- NAFLD, Non-alcoholic Fatty Liver Disease
- Keywords
- Mediterranean diet, Beetroot juice, nonalcoholic fatty liver
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Sulaimani Polytechnic UniversityUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 11 Apr 2023 (actual)
- First posted
- 18 Jun 2023 (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 goal of this clinical trial study is to investigate comparing Effects of Beetroot juice and Mediterranean diet on Liver Enzymes and Sonographic appearance in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD)
The main question[s] it aims to answer are:
- Beetroot juice has role in reduce Liver Enzymes
- Mediterranean diet has role in reduce Liver Enzymes
Detailed description
Patients with NAFLD were identified and enrolled for this research at the PAR hospital in the Kurdistan Region of Iraq.
For 12 weeks, for the group members who were receiving the MeD, we recommended consuming Mediterranean foods like fish, poultry, sources of omega-3, vegetables and colored fruits, legumes and nuts, and low-fat goods while avoiding inflammatory foods like high-fat foods, processed meats, fast food, simple sugars, chips, and soft drinks.
At baseline, the participants' demographic and anthropometric information, including as gender, age, weight, height, smoking status, location of residence, and physical activity, were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The participants were split into four groups: control, Mediterranean diet with beet juice (BJ+MeD), Mediterranean diet alone (MeD) and beetroot juice (BJ). The Mediterranean diet included fruits, vegetables, fish, poultry, and other lean meats (without skin), sources of omega-3 fatty acids, nuts, and legumes. Beetroot juice had 250 mg of beetroot.
| Arm | Type | Receives |
|---|---|---|
| 250 ml of a placebo | Placebo comparator | Other: placebo250 ml of a placebo |
| beetroot juice (BJ) | Experimental | Other: Beetroot juice250 ml of concentrated beetroot juice |
| Mediterranean diet with beet juice (BJ+MeD) | Experimental | Combination Product: Mediterranean diet with beet juice (BJ+MeD)Mediterranean diet with beet juice (BJ+MeD) |
| Mediterranean diet alone (MeD) | Experimental | Other: Mediterranean diet alone (MeD)Mediterranean diet alone (MeD) |
Who may qualify
- Ages
- 19 to 73 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients had to be between the ages of 19 and 73, and they had to have NAFLD as their main diagnosis.
- For a NAFLD diagnosis, ultrasound proof of fatty liver (stage I or above) and an elevated level of liver enzymes were required.
Key exclusion criteria (3 listed)
- history of diseases like cardiovascular, liver, chronic hepatitis C, and kidney disease
- supplement use within the previous six months; hormone therapy; use of drugs like amiodarone, methotrexate, and corticosteroids
- cases of starvation or inadequate nutrition; pregnancy; metabolic disorders like Wilson disease and glycogen storage disease; a history of liver irradiation
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 |
|---|---|---|
| Beetroot juice250 ml of concentrated beetroot juice, were given to participants in the BJ groups .This was carried out in the morning, 30 minutes before breakfast, and on an empty stomach. | Other | beetroot juice (BJ) |
| placebo250 ml of a placebo | Other | 250 ml of a placebo |
| Mediterranean diet alone (MeD)Mediterranean diet alone (MeD) | Other | Mediterranean diet alone (MeD) |
| Mediterranean diet with beet juice (BJ+MeD)Mediterranean diet with beet juice (BJ+MeD). | Combination product | Mediterranean diet with beet juice (BJ+MeD) |
Primary outcome
Beetroot juice has role in reduce liver enzymes
Time frame: 12 weeks
Beetroot juice was given for 12 weeks and has role in reduce Serum Bilirubin, alkaline phosphatase (ALP), alanine transaminase (ALT), and liver enzyme was measured by blood sampling tests.
1 secondary outcome
Mediterranean diet contributes to lower liver enzyme levels.
Time frame: 12 weeks
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 18 Jun 2023.
- Derived from this study: PubMed 37662597Fateh HL, Rashid SA, Muhammad SS, Al-Jaf SH, Ali AM. Comparing effects of beetroot juice and Mediterranean diet on liver enzymes and sonographic appearance in patients with non-alcoholic fatty liver disease: a randomized control trials. Front Nutr. 2023 Aug 17;10:1181706. doi: 10.3389/fnut.2023.1181706. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Hawal Lateef, Msc principal investigator
Nursing department, sulaimany polytechni university, kurdistan, iraq
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Beetroot juice, Mediterranean diet alone (MeD) and Mediterranean diet with beet juice (BJ+MeD) in people with NAFLD, Non-alcoholic Fatty Liver Disease, run by Sulaimani Polytechnic University at 1 site in Iraq.
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 2 inclusion and 3 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 18 Jun 2023. 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 Iraq. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Beetroot juice has role in reduce liver enzymes (time frame: 12 weeks). 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 NCT05909631, 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 18 Jun 2023.