Vegan Diet, Amla Fruits and Uric Acid

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hyperuricemia, Diet, Healthy, Cardiometabolic Syndrome

Intervention / Treatment
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* Other: Healthy vegan diet
* Other: My Plate - Low Purine
* Other: Amla fruits


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Vegan Diet<br>Education on healthy vegan diet | Other: Healthy vegan diet<br>* Participants will attend group lessons and individual nutrition counseling to help them adopt a healthy vegan diet.<br>|
| Experimental: Healthy Vegan Diet with Amla fruits<br>Education on healthy vegan diet, 3g of powdered amla fruits per day | Other: Healthy vegan diet<br>* Participants will attend group lessons and individual nutrition counseling to help them adopt a healthy vegan diet.<br>Other: Amla fruits<br>* Participants will be provided with powdered amla fruits, and will be instructed to take 3g per day.<br>|
| Active Comparator: My Plate - Low Purine<br>Education on My Plate diet with emphasis on choosing low purine protein options. | Other: My Plate - Low Purine<br>* 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.<br>|
| Experimental: My Plate - Low Purine with Amla Fruits.<br>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<br>* 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.<br>Other: Amla fruits<br>* Participants will be provided with powdered amla fruits, and will be instructed to take 3g per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uric acid | Serum uric acid | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index | body mass index calculated from height and weight | 3 months | 
| Glucose metabolism | fasting glucose | 3 months | 
| Lipid profile | cholesterol | 3 months | 
| vitamin B12 | serum vitamin B12 | 3 months | 
| holostranscobalamin | serum holotranscobalamin | 3 months | 
| homocysteine | serum homocysteine | 3 months | 
| vitamin D | serum 25(OH)D | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vegan diet, Uric acid, Cardiometabolic risk factors, Amla fruits