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CompletedNCT04801745Updated Oct 3, 2024

Vegan Diet, Amla Fruits and Uric Acid

An interventional study of Healthy vegan diet and My Plate - Low Purine in Hyperuricemia, Diet, Healthy and Cardiometabolic Syndrome, sponsored by Fu Jen Catholic University. Completed at 1 site in Taiwan. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-10-03.

Sponsored by Fu Jen Catholic University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hyperuricemia
  • Diet, Healthy
  • Cardiometabolic Syndrome

Keywords

  • Vegan diet
  • Uric acid
  • Cardiometabolic risk factors
  • Amla fruits
03

In context

Hyperuricemia

221 studies on the registry are indexed under Hyperuricemia; 41 are open to participants now.

This study's enrollment of 102 is above the median of 64 across 177 interventional studies indexed under Hyperuricemia.

Browse Hyperuricemia studies →

Lead sponsor

Fu Jen Catholic University is the lead sponsor of 46 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men with serum uric acid > 7mg/dL
  • Women with serum uric acid > 6mg/dL
  • Willing to make diet changes according to dietary interventions

Exclusion criteria

Exclusion Criteria:

  • Age \<19
  • With cancer diagnosis
  • With diseases that require special dietary needs
  • On urate-lowering medication within 3 months
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
102 participants (actual)

Study arms

  • Experimental
    Healthy Vegan Diet

    Education on healthy vegan diet

    Other: Healthy vegan diet

  • Experimental
    Healthy Vegan Diet with Amla fruits

    Education on healthy vegan diet, 3g of powdered amla fruits per day

    Other: Healthy vegan diet · Other: Amla fruits

  • Active comparator
    My Plate - Low Purine

    Education on "My Plate" diet with emphasis on choosing low purine protein options.

    Other: My Plate - Low Purine

  • Experimental
    My Plate - Low Purine with Amla Fruits.

    Education on "My Plate" diet with emphasis on choosing low purine protein options and with an addition of 3g of amla powder per day.

    Other: My Plate - Low Purine · Other: Amla fruits

Interventions

  • OtherHealthy vegan diet

    Participants will attend group lessons and individual nutrition counseling to help them adopt a healthy vegan diet.

  • OtherMy Plate - Low Purine

    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.

  • OtherAmla fruits

    Participants will be provided with powdered amla fruits, and will be instructed to take 3g per day.

06

What researchers measure

Primary outcomes

  1. Uric acid

    Serum uric acid

    Time frame: 3 months

Secondary outcomes

  1. Body mass index

    body mass index calculated from height and weight

    Time frame: 3 months

  2. Glucose metabolism

    fasting glucose

    Time frame: 3 months

  3. Lipid profile

    cholesterol

    Time frame: 3 months

  4. vitamin B12

    serum vitamin B12

    Time frame: 3 months

  5. holostranscobalamin

    serum holotranscobalamin

    Time frame: 3 months

  6. homocysteine

    serum homocysteine

    Time frame: 3 months

  7. vitamin D

    serum 25(OH)D

    Time frame: 3 months

07

Study locations

1 site
  • Department of Nutritional Science, Fu-Jen Catholic University
    New Taipei City, 24205, Taiwan
08

References and documents

Individual participant data

Plan to share: Undecided — IPD may be shared after the results have been published in peer review journals.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04801745
Lead sponsor
Fu Jen Catholic University
Responsible party
Tina Hsueh-Ting Chiu (Assistant Professor, Fu Jen Catholic University) — Principal investigator
First posted
Mar 17, 2021
Start date
Mar 20, 2021
Primary completion
Jan 30, 2024
Completion
Jan 30, 2024
Last update
Oct 3, 2024

Study contacts

Tina Hsueh-Ting Chiu, PhD
principal investigator · Fu-Jen Catholic University, Department of Nutritional Science

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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