NCT04801745

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

March 20, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

October 3, 2024

Status Verified

October 1, 2024

Enrollment Period

2.9 years

First QC Date

February 28, 2021

Last Update Submit

October 1, 2024

Conditions

HyperuricemiaDiet, HealthyCardiometabolic Syndrome

Keywords

Vegan dietUric acidCardiometabolic risk factorsAmla fruits

Outcome Measures

Primary Outcomes (1)

  • Uric acid

    Serum uric acid

    3 months

Secondary Outcomes (7)

  • Body mass index

    3 months

  • Glucose metabolism

    3 months

  • Lipid profile

    3 months

  • vitamin B12

    3 months

  • holostranscobalamin

    3 months

  • +2 more secondary outcomes

Study Arms (4)

Healthy Vegan Diet

EXPERIMENTAL

Education on healthy vegan diet

Other: Healthy vegan diet

Healthy Vegan Diet with Amla fruits

EXPERIMENTAL

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

Other: Healthy vegan dietOther: Amla fruits

My Plate - Low Purine

ACTIVE COMPARATOR

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

Other: My Plate - Low Purine

My Plate - Low Purine with Amla Fruits.

EXPERIMENTAL

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 PurineOther: Amla fruits

Interventions

Healthy vegan dietOTHER

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

Healthy Vegan DietHealthy Vegan Diet with Amla fruits
My Plate - Low PurineOTHER

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 PurineMy Plate - Low Purine with Amla Fruits.
Amla fruitsOTHER

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

Healthy Vegan Diet with Amla fruitsMy Plate - Low Purine with Amla Fruits.

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men with serum uric acid \> 7mg/dL
  • Women with serum uric acid \> 6mg/dL
  • Willing to make diet changes according to dietary interventions

You may not qualify if:

  • Age \<19
  • With cancer diagnosis
  • With diseases that require special dietary needs
  • On urate-lowering medication within 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutritional Science, Fu-Jen Catholic University

New Taipei City, 24205, Taiwan

Location

MeSH Terms

Conditions

HyperuricemiaMetabolic Syndrome

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Tina Hsueh-Ting Chiu, PhD

    Fu-Jen Catholic University, Department of Nutritional Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 28, 2021

First Posted

March 17, 2021

Study Start

March 20, 2021

Primary Completion

January 30, 2024

Study Completion

January 30, 2024

Last Updated

October 3, 2024

Record last verified: 2024-10

Locations

TW(1)