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Completed

NCT Number: NCT04801745

Vegan Diet, Amla Fruits and Uric Acid

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.

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Key information

Conditions

Hyperuricemia Cardiometabolic Syndrome Diet, Healthy Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutritional Science, Fu-Jen Catholic University

New Taipei City, 24205, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Healthy vegan diet

Other

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

My Plate - Low Purine

Other

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 fruits

Other

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

Primary outcomes

  1. Uric acid

    Time frame: 3 months

    Serum uric acid

Secondary outcomes

  1. Body mass index

    Time frame: 3 months

    body mass index calculated from height and weight

  2. Glucose metabolism

    Time frame: 3 months

    fasting glucose

  3. Lipid profile

    Time frame: 3 months

    cholesterol

  4. vitamin B12

    Time frame: 3 months

    serum vitamin B12

  5. holostranscobalamin

    Time frame: 3 months

    serum holotranscobalamin

  6. homocysteine

    Time frame: 3 months

    serum homocysteine

  7. vitamin D

    Time frame: 3 months

    serum 25(OH)D

Sponsors and collaborators

Lead sponsor

Fu Jen Catholic University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 17, 2021
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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