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Vegan Diet, Amla Fruits and Uric Acid

Primary Purpose

Hyperuricemia, Diet, Healthy, Cardiometabolic Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Healthy vegan diet
My Plate - Low Purine
Amla fruits
Sponsored by
Fu Jen Catholic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperuricemia focused on measuring Vegan diet, Uric acid, Cardiometabolic risk factors, Amla fruits

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Nutritional Science, Fu-Jen Catholic UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Arm Label

Healthy Vegan Diet

Healthy Vegan Diet with Amla fruits

My Plate - Low Purine

My Plate - Low Purine with Amla Fruits.

Arm Description

Education on healthy vegan diet

Education on healthy vegan diet, 3g of powdered amla fruits per day

Education on "My Plate" diet with emphasis on choosing low purine protein options.

Education on "My Plate" diet with emphasis on choosing low purine protein options and with an addition of 3g of amla powder per day.

Outcomes

Primary Outcome Measures

Uric acid
Serum uric acid

Secondary Outcome Measures

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

Full Information

First Posted
February 28, 2021
Last Updated
November 4, 2022
Sponsor
Fu Jen Catholic University
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1. Study Identification

Unique Protocol Identification Number
NCT04801745
Brief Title
Vegan Diet, Amla Fruits and Uric Acid
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fu Jen Catholic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia, Diet, Healthy, Cardiometabolic Syndrome
Keywords
Vegan diet, Uric acid, Cardiometabolic risk factors, Amla fruits

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Vegan Diet
Arm Type
Experimental
Arm Description
Education on healthy vegan diet
Arm Title
Healthy Vegan Diet with Amla fruits
Arm Type
Experimental
Arm Description
Education on healthy vegan diet, 3g of powdered amla fruits per day
Arm Title
My Plate - Low Purine
Arm Type
Active Comparator
Arm Description
Education on "My Plate" diet with emphasis on choosing low purine protein options.
Arm Title
My Plate - Low Purine with Amla Fruits.
Arm Type
Experimental
Arm Description
Education on "My Plate" diet with emphasis on choosing low purine protein options and with an addition of 3g of amla powder per day.
Intervention Type
Other
Intervention Name(s)
Healthy vegan diet
Intervention Description
Participants will attend group lessons and individual nutrition counseling to help them adopt a healthy vegan diet.
Intervention Type
Other
Intervention Name(s)
My Plate - Low Purine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Amla fruits
Intervention Description
Participants will be provided with powdered amla fruits, and will be instructed to take 3g per day.
Primary Outcome Measure Information:
Title
Uric acid
Description
Serum uric acid
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Body mass index
Description
body mass index calculated from height and weight
Time Frame
3 months
Title
Glucose metabolism
Description
fasting glucose
Time Frame
3 months
Title
Lipid profile
Description
cholesterol
Time Frame
3 months
Title
vitamin B12
Description
serum vitamin B12
Time Frame
3 months
Title
holostranscobalamin
Description
serum holotranscobalamin
Time Frame
3 months
Title
homocysteine
Description
serum homocysteine
Time Frame
3 months
Title
vitamin D
Description
serum 25(OH)D
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tina Hsueh-Ting Chiu, PhD
Phone
+886-2-2905-3541
Email
tina925@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tina Hsueh-Ting Chiu, PhD
Organizational Affiliation
Fu-Jen Catholic University, Department of Nutritional Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nutritional Science, Fu-Jen Catholic University
City
New Taipei City
ZIP/Postal Code
24205
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tina Chiu, PhD
Phone
+885-2-2905-3541
Email
tina925@gmail.com
First Name & Middle Initial & Last Name & Degree
Tina Chiu, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
IPD may be shared after the results have been published in peer review journals.

Learn more about this trial

Vegan Diet, Amla Fruits and Uric Acid

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