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The Diet Gout Trial (DIGO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03569020
Recruitment Status : Completed
First Posted : June 26, 2018
Last Update Posted : November 27, 2019
Sponsor:
Collaborators:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Harvard Medical School
Rheumatology Research Foundation
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Gout Hyperuricemia Other: Subsidy for food purchases and dietitian education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Double (Investigator, Outcomes 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.
Primary Purpose: Treatment
Official Title: Dietary Approaches to Stop Hypertension (DASH) Diet Effects on Serum Uric Acid (SUA) in Adults With Hyperuricemia and Gout
Actual Study Start Date : August 7, 2018
Actual Primary Completion Date : July 23, 2019
Actual Study Completion Date : July 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gout

Arm Intervention/treatment
Experimental: Dietitian-Directed Diet
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.
Other: Subsidy for food purchases and dietitian education
$105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet.

No Intervention: Self-Directed Diet
Participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period.



Primary Outcome Measures :
  1. Uric acid level [ Time Frame: Baseline ]
    Measured in serum

  2. Uric acid level [ Time Frame: At 4-weeks ]
    Measured in serum

  3. Uric acid level [ Time Frame: At 8-weeks ]
    Measured in serum


Secondary Outcome Measures :
  1. Blood pressure as assessed by systolic and diastolic blood pressure [ Time Frame: Baseline ]
  2. Blood pressure as assessed by systolic and diastolic blood pressure [ Time Frame: At 4-weeks ]
  3. Blood pressure as assessed by systolic and diastolic blood pressure [ Time Frame: At 8-weeks ]
  4. Change in Fasting blood glucose [ Time Frame: Baseline, 4-weeks, 8-weeks ]
    Measured in serum

  5. Change in Fasting lipid panel [ Time Frame: Baseline, 4-weeks, 8-weeks ]
    Measured in serum

  6. Change in Body mass index [ Time Frame: Baseline, 4-weeks, 8-weeks ]
    Derived from baseline height, and serial weight measurements



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03569020


Locations
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United States, Maryland
Johns Hopkins ProHealth Research Clinic
Woodlawn, Maryland, United States, 21207
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Johns Hopkins University
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Harvard Medical School
Rheumatology Research Foundation
Investigators
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Principal Investigator: Edgar Miller Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:
Informed Consent Form  [PDF] October 29, 2018
Study Protocol  [PDF] June 10, 2019
Statistical Analysis Plan  [PDF] May 20, 2019

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03569020    
Other Study ID Numbers: IRB00153409
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
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
Additional relevant MeSH terms:
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Gout
Hyperuricemia
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Pathologic Processes