Vegan Diet, Amla Fruits and Uric Acid

Not Applicable

Completed

• Conditions: Hyperuricemia; Diet, Healthy; Cardiometabolic Syndrome
• Interventions: Other: My Plate - Low Purine; Other: Healthy vegan diet; Other: Amla fruits

• Registration Number: NCT04801745
• Lead Sponsor: Fu Jen Catholic University

Brief 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.

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 Timeline

• Study First Submitted: 2021-02-28
• Study First Submitted QC: 2021-03-12
• Study First Posted: 2021-03-17
• Study Start: 2021-03-20
• Primary Completion: 2024-01-30
• Study Completion: 2024-01-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
My Plate - Low Purine with Amla Fruits.	My Plate - Low Purine	Education on "My Plate" diet with emphasis on choosing low purine protein options and with an addition of 3g of amla powder per day.
Healthy Vegan Diet with Amla fruits	Healthy vegan diet	Education on healthy vegan diet, 3g of powdered amla fruits per day
Healthy Vegan Diet	Healthy vegan diet	Education on healthy vegan diet
Healthy Vegan Diet with Amla fruits	Amla fruits	Education on healthy vegan diet, 3g of powdered amla fruits per day
My Plate - Low Purine with Amla Fruits.	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.
My Plate - Low Purine	My Plate - Low Purine	Education on "My Plate" diet with emphasis on choosing low purine protein options.

Primary Outcome Measures

Name	Time	Method
Uric acid	3 months	Serum uric acid

Secondary Outcome Measures

Name	Time	Method
Glucose metabolism	3 months	fasting glucose
homocysteine	3 months	serum homocysteine
vitamin D	3 months	serum 25(OH)D
Body mass index	3 months	body mass index calculated from height and weight
holostranscobalamin	3 months	serum holotranscobalamin
Lipid profile	3 months	cholesterol
vitamin B12	3 months	serum vitamin B12

Trial Locations

Locations (1)

Department of Nutritional Science, Fu-Jen Catholic University; 🇨🇳 New Taipei City, Taiwan