HyperuricemiaNCT04801745
Vegan Diet, Amla Fruits and Uric Acid
A study testing Healthy vegan diet, My Plate - Low Purine and Amla fruits in people with Hyperuricemia and Diet, Healthy, run by Fu Jen Catholic University at 1 site in Taiwan.
Trial summary
This is an intervention study aiming to test the effectiveness of a vegan diet, My Plate with low purine choices, and amla fruits on uric acid and other cardiometabolic risk factors in individuals with high serum uric acid levels. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hyperuricemia, Diet, Healthy, Cardiometabolic Syndrome
- What is being tested?
- Healthy vegan diet, My Plate - Low Purine and Amla fruits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Mar 2021to 30 Jan 2024
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men with serum uric acid > 7mg/dL
- Women with serum uric acid > 6mg/dL
- Willing to make diet changes according to dietary interventions
Who cannot join
- Age <19
- With cancer diagnosis
- With diseases that require special dietary needs
- On urate-lowering medication within 3 months
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Nutritional Science, Fu-Jen Catholic University
New Taipei City, 24205
About this study
Official title: Effects of a Healthy Vegan Diet Vs. Low Purine Diet, with or Without Amla Fruits (Emblica Officinalis) on Hyperuricemia and Other Cardiometabolic Risk Factors: a Randomized Two-by-two Factorial Trial
This is an intervention study aiming to test the effectiveness of a vegan diet, My Plate with low purine choices, and amla fruits on uric acid and other cardiometabolic risk factors in individuals with high serum uric acid levels.
Read the detailed description
Ninety-two participants with hyperuricemia will be randomly assigned to one of these 4 diet interventions: (1) vegan, (2) vegan with amla fruits, (3) my plate-low purine, (4) my plate-low purine with amla fruits. During the 3 months intervention phase, participants will attend group lessons and individual nutrition counseling sessions to assist adherence to the diet. At baseline, end of 3 months, and 1 year, participants will be measured on uric acid and other cardiometabolic risk factors, and some nutritional markers. Amla fruits powder, and some foods encouraged in each dietary arm will be provided to enhance adherence during the 3 months intervention phase.
- Conditions
- Hyperuricemia, Diet, Healthy, Cardiometabolic Syndrome
- Being tested
- Healthy vegan diet, My Plate - Low Purine, Amla fruits
- Keywords
- Vegan diet, Uric acid, Cardiometabolic risk factors, Amla fruits
- Medical subject headings
- Hyperuricemia, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy vegan dietOther
Participants will attend group lessons and individual nutrition counseling to help them adopt a healthy vegan diet.
My Plate - Low PurineOther
Participants will attend group lessons and individual nutrition counseling to help them adopt a balanced diet in accordance with my plate, and emphasis on choosing low purine options from the protein food groups.
Amla fruitsOther
Participants will be provided with powdered amla fruits, and will be instructed to take 3g per day.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Vegan Diet | Experimental | Education on healthy vegan diet Receives: Other: Healthy vegan diet |
| Healthy Vegan Diet with Amla fruits | Experimental | Education on healthy vegan diet, 3g of powdered amla fruits per day Receives: Other: Healthy vegan diet; Other: Amla fruits |
| My Plate - Low Purine | Active comparator | Education on "My Plate" diet with emphasis on choosing low purine protein options. Receives: Other: My Plate - Low Purine |
| My Plate - Low Purine with Amla Fruits. | Experimental | Education on "My Plate" diet with emphasis on choosing low purine protein options and with an addition of 3g of amla powder per day. Receives: Other: My Plate - Low Purine; Other: Amla fruits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uric acid
Serum uric acid
Measured: 3 months
Secondary outcomes (7)
Body mass index
body mass index calculated from height and weight
Measured: 3 months
Glucose metabolism
fasting glucose
Measured: 3 months
Lipid profile
cholesterol
Measured: 3 months
vitamin B12
serum vitamin B12
Measured: 3 months
holostranscobalamin
serum holotranscobalamin
Measured: 3 months
homocysteine
serum homocysteine
Measured: 3 months
vitamin D
serum 25(OH)D
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start20 Mar 2021
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tina Hsueh-Ting Chiu, Fu Jen Catholic University
- Investigators
- Tina Hsueh-Ting Chiu, PhD, Principal investigator, Fu-Jen Catholic University, Department of Nutritional Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801745
- Sponsor's protocol ID
- Interventional
- Status last verified
- Oct 2024
- First submitted
- 28 Feb 2021
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may be shared after the results have been published in peer review journals.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Healthy Vegan Diet Vs. Low Purine Diet, with or Without Amla Fruits (Emblica Officinalis) on Hyperuricemia and Other Cardiometabolic Risk Factors: a Randomized Two-by-two Factorial Trial
- ClinicalTrials.gov ID
- NCT04801745
- Acronym / sponsor ID
- Interventional
- Conditions
- Hyperuricemia, Diet, Healthy, Cardiometabolic Syndrome
- Keywords
- Vegan diet, Uric acid, Cardiometabolic risk factors, Amla fruits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Fu Jen Catholic UniversityUniversity, hospital or other
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 17 Mar 2021 (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.
This is an intervention study aiming to test the effectiveness of a vegan diet, My Plate with low purine choices, and amla fruits on uric acid and other cardiometabolic risk factors in individuals with high serum uric acid levels.
Detailed description
Ninety-two participants with hyperuricemia will be randomly assigned to one of these 4 diet interventions: (1) vegan, (2) vegan with amla fruits, (3) my plate-low purine, (4) my plate-low purine with amla fruits. During the 3 months intervention phase, participants will attend group lessons and individual nutrition counseling sessions to assist adherence to the diet. At baseline, end of 3 months, and 1 year, participants will be measured on uric acid and other cardiometabolic risk factors, and some nutritional markers. Amla fruits powder, and some foods encouraged in each dietary arm will be provided to enhance adherence during the 3 months intervention phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Vegan Diet | Experimental | Other: Healthy vegan dietEducation on healthy vegan diet |
| Healthy Vegan Diet with Amla fruits | Experimental | Other: Healthy vegan diet, Other: Amla fruitsEducation on healthy vegan diet, 3g of powdered amla fruits per day |
| My Plate - Low Purine | Active comparator | Other: My Plate - Low PurineEducation on "My Plate" diet with emphasis on choosing low purine protein options. |
| My Plate - Low Purine with Amla Fruits. | Experimental | Other: My Plate - Low Purine, Other: Amla fruitsEducation on "My Plate" diet with emphasis on choosing low purine protein options and with an addition of 3g of amla powder per day. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men with serum uric acid > 7mg/dL
- Women with serum uric acid > 6mg/dL
- Willing to make diet changes according to dietary interventions
Key exclusion criteria (4 listed)
- Age <19
- With cancer diagnosis
- With diseases that require special dietary needs
- On urate-lowering medication within 3 months
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 |
|---|---|---|
| Healthy vegan dietParticipants will attend group lessons and individual nutrition counseling to help them adopt a healthy vegan diet. | Other | Healthy Vegan Diet, Healthy Vegan Diet with Amla fruits |
| My Plate - Low PurineParticipants will attend group lessons and individual nutrition counseling to help them adopt a balanced diet in accordance with my plate, and emphasis on choosing low purine options from the protein food groups. | Other | My Plate - Low Purine, My Plate - Low Purine with Amla Fruits. |
| Amla fruitsParticipants will be provided with powdered amla fruits, and will be instructed to take 3g per day. | Other | Healthy Vegan Diet with Amla fruits, My Plate - Low Purine with Amla Fruits. |
Primary outcome
Uric acid
Time frame: 3 months
Serum uric acid
7 secondary outcomes
Body mass index
Time frame: 3 months
Glucose metabolism
Time frame: 3 months
Lipid profile
Time frame: 3 months
vitamin B12
Time frame: 3 months
holostranscobalamin
Time frame: 3 months
homocysteine
Time frame: 3 months
vitamin D
Time frame: 3 months
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 3 Oct 2024.
- Individual participant dataSharing planned: Undecided. IPD may be shared after the results have been published in peer review journals.
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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.
Tina Hsueh-Ting Chiu, PhD principal investigator
Fu-Jen Catholic University, Department of Nutritional Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy vegan diet, My Plate - Low Purine and Amla fruits in people with Hyperuricemia and Diet, Healthy, run by Fu Jen Catholic University at 1 site in Taiwan.
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 3 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 3 Oct 2024. 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 Taiwan. 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?
Uric acid (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2024.