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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Fu Jen Catholic University
- Enrollment
- 102
- Locations
- 2
- Primary Endpoint
- Uric acid
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •With cancer diagnosis
- •With diseases that require special dietary needs
- •On urate-lowering medication within 3 months
Outcomes
Primary Outcomes
Uric acid
Time Frame: 3 months
Serum uric acid
Secondary Outcomes
- vitamin B12(3 months)
- homocysteine(3 months)
- vitamin D(3 months)
- Body mass index(3 months)
- holostranscobalamin(3 months)
- Glucose metabolism(3 months)
- Lipid profile(3 months)
Investigators
Tina Hsueh-Ting Chiu
Assistant Professor
Fu Jen Catholic University