Vegan Diet, Amla Fruits and Uric Acid

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hyperuricemia; Diet, Healthy; Cardiometabolic Syndrome
• Intervention / Treatment: Other: Healthy vegan diet; Other: Amla fruits; Other: My Plate - Low Purine

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 Type: Interventional
• Enrollment (Anticipated): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 24205
    • Recruiting
    • Department of Nutritional Science, Fu-Jen Catholic University
    • Contact: Tina Chiu, PhD; Phone Number: +885-2-2905-3541; Email: tina925@gmail.com
    • Principal Investigator: Tina Chiu, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fu Jen Catholic University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 20, 2021
• Primary Completion (ANTICIPATED): June 30, 2024
• Study Completion (ANTICIPATED): June 30, 2024

Study Registration Dates

• First Submitted: February 28, 2021
• First Submitted That Met QC Criteria: March 12, 2021
• First Posted (ACTUAL): March 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Uric acid; Cardiometabolic risk factors; Vegan diet; Amla fruits
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome; Hyperuricemia
• Other Study ID Numbers: interventional (Oncolys BioPharma Inc)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD may be shared after the results have been published in peer review journals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No