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The Diet Gout Trial (DIGO)

Primary Purpose

Gout, Hyperuricemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Subsidy for food purchases and dietitian education
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gout focused on measuring Diet, Nutrition, DASH, Gout, Hyperuricemia, Potassium, Uric acid, Trial, Blood pressure, Glucose, Lipid, Cholesterol, Weight, Arthritis, BMI, Body mass index, Fruit, Vegetable, Low fat dairy, Lean meat, Fiber

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age > 18-100 years

Self-reported gout diagnosis

Serum Uric Acid > 7 mg/dL

Exclusion Criteria:

Recent or planned changes to urate lowering therapies (e.g. allopurinol, febuxostat, probenecid)

Recent or planned changes to hypertension, lipid, or diabetes medications

Patients with hyperkalemia (>5 mmol/L)

Chronic kidney disease (GFR < 30 cc/min), kidney transplant, dialysis

Gastro-intestinal conditions (e.g. history of gastric bypass surgery, active inflammatory bowel disease, malabsorption, or major GI resection)

Active cancer treatment (e.g. radiation or chemotherapy)

Diagnosis of any of the following in the past 6 months: heart attack, heart failure, angina, coronary bypass or angioplasty, or Chronic Obstructive Pulmonary Disease (COPD)

Alcohol use over 14 drinks per week

Inability to give informed consent

Active use of warfarin, insulin, or chronic steroids (like prednisone)

Terminal or mental illness

Sites / Locations

  • Johns Hopkins ProHealth Research Clinic
  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dietitian-Directed Diet

Self-Directed Diet

Arm Description

Participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.

Participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period.

Outcomes

Primary Outcome Measures

Uric Acid Level
Measured in serum
Uric Acid Level
Measured in serum
Uric Acid Level
Measured in serum

Secondary Outcome Measures

Systolic Blood Pressure (mm Hg)
Diastolic Blood Pressure (mm Hg)
Fasting Blood Glucose (mg/dL)
Measured in serum
Low Density Lipoprotein Cholesterol (mg/dL)
Measured in serum
Body Mass Index (kg/m^2)
Derived from baseline height, and serial weight measurements

Full Information

First Posted
June 14, 2018
Last Updated
March 3, 2021
Sponsor
Johns Hopkins University
Collaborators
Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Harvard Medical School (HMS and HSDM), Rheumatology Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03569020
Brief Title
The Diet Gout Trial
Acronym
DIGO
Official Title
Dietary Approaches to Stop Hypertension (DASH) Diet Effects on Serum Uric Acid (SUA) in Adults With Hyperuricemia and Gout
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 7, 2018 (Actual)
Primary Completion Date
July 23, 2019 (Actual)
Study Completion Date
July 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Harvard Medical School (HMS and HSDM), Rheumatology Research Foundation

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
Unhealthy diet has long been associated with high uric acid levels and gout. The DASH diet may lower uric acid levels. This study will examine the effects of the DASH diet on uric acid in adults with a history of gout.
Detailed Description
The public health burden of gout is substantial. Several lines of evidence suggest that a DASH diet might lower uric acid. However, there are no trials of the DASH diet in adults with gout. This trial is a cross-over study of the effects of a DASH-like diet on uric acid in adults with gout and hyperuricemia, who are not taking urate-lowering therapy. Perpetuated by the "Western" lifestyle and resulting obesity epidemic, the prevalence of gout has increased over the past few decades to 3.9% of US adults (8.3 million individuals). This prevalence increases with age to 9.3% of US adults over 60 years (4.7 million). Participants will be community-dwelling adults, aged 18+ with a baseline serum uric acid level of 7 mg/dL, who have a self-reported history of gout and are not taking urate lowering medications (e.g. allopurinol, febuxostat, probenecid). This trial is comprised of two study periods: (1) a dietitian-directed diet (DD) or (2) self-directed usual diet (SD). Each period lasts 4 weeks. All participants will participate in both periods, but half will undergo the dietitian-directed diet first while the other half will undergo the self-directed diet first. During the dietitian-directed diet, participants will receive $105/week of foods in a pattern that conforms to the DASH diet. The DASH diet emphasizes fruit, vegetables, lean meat, low fat dairy, and high fiber, while restricting red meat, sweets, and sugary beverages. During the self-directed diet, participants will be asked to eat their typical diet outside of the study. Investigators anticipate 40 participants in this study. The primary outcome is uric acid. Secondary outcomes of this study include: body mass index, systolic and diastolic blood pressure, fasting cholesterol, and fasting blood glucose. Both primary and secondary outcomes will be measured 3 times: (1) before the study begins (baseline), (2) after period 1 (at 4 weeks), and (3) after period 2 (at 8 weeks). Patient-reported outcomes, dietary compliance, and urine electrolytes will be assessed throughout the study as well. The primary comparison will be serum uric acid concentrations measured after the 4-week dietitian-directed diet versus uric acid concentrations measured after the 4-week self-directed diet (DD vs. SD). Comparisons will be made within person using generalized estimating equations (GEE) with and without adjustment for baseline uric acid concentration. Investigators will use GEE models for secondary outcomes as well.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout, Hyperuricemia
Keywords
Diet, Nutrition, DASH, Gout, Hyperuricemia, Potassium, Uric acid, Trial, Blood pressure, Glucose, Lipid, Cholesterol, Weight, Arthritis, BMI, Body mass index, Fruit, Vegetable, Low fat dairy, Lean meat, Fiber

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Half of participants will be randomly assigned 1 of 2 potential sequences. All participants will ultimately participate in each study period, but the order will be randomly assigned 1:1.
Masking
InvestigatorOutcomes Assessor
Masking Description
Investigators will not know which assignment the participants were given. The laboratory measuring uric acid will not know which intervention the participants were assigned.
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietitian-Directed Diet
Arm Type
Experimental
Arm Description
Participants will be provided $105/week ($15/day) to purchase foods in servings that correspond to the DASH diet and thus include fruits, vegetables, lean meat, low fat dairy, and high fiber foods. Participants will also be asked to restrict red meat, sweets, and sugary beverages during this intervention period. A dietitian will help participants order foods from a digital supermarket. Foods will be delivered to the Johns Hopkins ProHealth Research Clinic for weekly pick-up. This study period will last 4 weeks.
Arm Title
Self-Directed Diet
Arm Type
No Intervention
Arm Description
Participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period.
Intervention Type
Other
Intervention Name(s)
Subsidy for food purchases and dietitian education
Intervention Description
$105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet.
Primary Outcome Measure Information:
Title
Uric Acid Level
Description
Measured in serum
Time Frame
Baseline
Title
Uric Acid Level
Description
Measured in serum
Time Frame
At 4-weeks
Title
Uric Acid Level
Description
Measured in serum
Time Frame
At 8-weeks
Secondary Outcome Measure Information:
Title
Systolic Blood Pressure (mm Hg)
Time Frame
Baseline, 4-weeks, 8-weeks
Title
Diastolic Blood Pressure (mm Hg)
Time Frame
At baseline, 4-weeks, 8-weeks
Title
Fasting Blood Glucose (mg/dL)
Description
Measured in serum
Time Frame
Baseline, 4-weeks, 8-weeks
Title
Low Density Lipoprotein Cholesterol (mg/dL)
Description
Measured in serum
Time Frame
Baseline, 4-weeks, 8-weeks
Title
Body Mass Index (kg/m^2)
Description
Derived from baseline height, and serial weight measurements
Time Frame
Baseline, 4-weeks, 8-weeks

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age > 18-100 years Self-reported gout diagnosis Serum Uric Acid > 7 mg/dL Exclusion Criteria: Recent or planned changes to urate lowering therapies (e.g. allopurinol, febuxostat, probenecid) Recent or planned changes to hypertension, lipid, or diabetes medications Patients with hyperkalemia (>5 mmol/L) Chronic kidney disease (GFR < 30 cc/min), kidney transplant, dialysis Gastro-intestinal conditions (e.g. history of gastric bypass surgery, active inflammatory bowel disease, malabsorption, or major GI resection) Active cancer treatment (e.g. radiation or chemotherapy) Diagnosis of any of the following in the past 6 months: heart attack, heart failure, angina, coronary bypass or angioplasty, or Chronic Obstructive Pulmonary Disease (COPD) Alcohol use over 14 drinks per week Inability to give informed consent Active use of warfarin, insulin, or chronic steroids (like prednisone) Terminal or mental illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edgar Miller
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins ProHealth Research Clinic
City
Woodlawn
State/Province
Maryland
ZIP/Postal Code
21207
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33186448
Citation
Ghazi L, Drawz PE, Pajewski NM, Juraschek SP. The Association of Orthostatic Hypotension With Ambulatory Blood Pressure Phenotypes in SPRINT. Am J Hypertens. 2021 May 22;34(5):511-520. doi: 10.1093/ajh/hpaa184.
Results Reference
derived
PubMed Identifier
32933342
Citation
Miller HN, Charleston J, Wu B, Gleason K, White K, Dennison Himmelfarb CR, Ford DE, Plante TB, Gelber AC, Appel LJ, Miller ER 3rd, Juraschek SP. Use of electronic recruitment methods in a clinical trial of adults with gout. Clin Trials. 2021 Feb;18(1):92-103. doi: 10.1177/1740774520956969. Epub 2020 Sep 15.
Results Reference
derived
Links:
URL
https://www.mdpi.com/2072-6643/13/2/538/htm
Description
Main results paper

Learn more about this trial

The Diet Gout Trial

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