Vegan Diet, Amla Fruits and Uric Acid

Diet, Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04801745
• Other study ID #: Interventional
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2022
• Source: Fu Jen Catholic University
• Contact: Tina Hsueh-Ting Chiu, PhD
• Phone: +886-2-2905-3541
• Email: tina925[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiometabolic Syndrome
• Diet, Healthy
• Hyperuricemia
• Metabolic Syndrome

Intervention

Other:
• Healthy vegan diet
Participants will attend group lessons and individual nutrition counseling to help them adopt a healthy vegan diet.
• My 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.
• Amla fruits
Participants will be provided with powdered amla fruits, and will be instructed to take 3g per day.

Locations

Country	Name	City	State
Taiwan	Department of Nutritional Science, Fu-Jen Catholic University	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Fu Jen Catholic University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uric acid	Serum uric acid	3 months
Secondary	Body mass index	body mass index calculated from height and weight	3 months
Secondary	Glucose metabolism	fasting glucose	3 months
Secondary	Lipid profile	cholesterol	3 months
Secondary	vitamin B12	serum vitamin B12	3 months
Secondary	holostranscobalamin	serum holotranscobalamin	3 months
Secondary	homocysteine	serum homocysteine	3 months
Secondary	vitamin D	serum 25(OH)D	3 months