Vegan Diet, Amla Fruits and Uric Acid

NCT ID: NCT04801745

Last Updated: 2024-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-20

Study Completion Date

2024-01-30

Brief Summary

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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

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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.

Conditions

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Hyperuricemia Diet, Healthy Cardiometabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Healthy Vegan Diet

Education on healthy vegan diet

Group Type EXPERIMENTAL

Healthy vegan diet

Intervention Type OTHER

Participants will attend group lessons and individual nutrition counseling to help them adopt a healthy vegan diet.

Healthy Vegan Diet with Amla fruits

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

Group Type EXPERIMENTAL

Healthy vegan diet

Intervention Type OTHER

Participants will attend group lessons and individual nutrition counseling to help them adopt a healthy vegan diet.

Amla fruits

Intervention Type OTHER

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

My Plate - Low Purine

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

Group Type ACTIVE_COMPARATOR

My Plate - Low Purine

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

My Plate - Low Purine

Intervention Type OTHER

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

Intervention Type OTHER

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

Interventions

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Healthy vegan diet

Participants will attend group lessons and individual nutrition counseling to help them adopt a healthy vegan diet.

Intervention Type 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.

Intervention Type OTHER

Amla fruits

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fu Jen Catholic University

OTHER

Sponsor Role lead

Responsible Party

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Tina Hsueh-Ting Chiu

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tina Hsueh-Ting Chiu, PhD

Role: PRINCIPAL_INVESTIGATOR

Fu-Jen Catholic University, Department of Nutritional Science

Locations

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Department of Nutritional Science, Fu-Jen Catholic University

New Taipei City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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Interventional

Identifier Type: -

Identifier Source: org_study_id

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