Vegan Diet, Amla Fruits and Uric Acid

Sponsor

Fu Jen Catholic University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04801745

Collaborator

(none)

Enrollment

Location

Arms

27.3

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperuricemia Diet, Healthy Cardiometabolic Syndrome	Other: Healthy vegan diet Other: My Plate - Low Purine Other: Amla fruits	N/A

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

Anticipated Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Mar 20, 2021

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

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: 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. Other: Amla fruits Participants will be provided with powdered amla fruits, and will be instructed to take 3g per day.

Outcome Measures

Primary Outcome Measures

Uric acid [3 months]
Serum uric acid

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Nutritional Science, Fu-Jen Catholic University	New Taipei City		Taiwan	24205

Sponsors and Collaborators

Fu Jen Catholic University

Investigators

Principal Investigator: Tina Hsueh-Ting Chiu, PhD, Fu-Jen Catholic University, Department of Nutritional Science

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tina Hsueh-Ting Chiu, Assistant Professor, Fu Jen Catholic University

ClinicalTrials.gov Identifier:

NCT04801745

Other Study ID Numbers:

Interventional

First Posted:

Mar 17, 2021

Last Update Posted:

Mar 17, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Tina Hsueh-Ting Chiu, Assistant Professor, Fu Jen Catholic University

Vegan diet

Uric acid

Cardiometabolic risk factors

Amla fruits

Additional relevant MeSH terms:

Metabolic Syndrome

Hyperuricemia

Study Results

No Results Posted as of Mar 17, 2021