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Completed

NCT Number: NCT03569020

The Diet Gout Trial

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins ProHealth Research Clinic, Woodlawn, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Subsidy for food purchases and dietitian education

Other

$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 outcomes

  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 outcomes

  1. Systolic Blood Pressure (mm Hg)

    Time frame: Baseline, 4-weeks, 8-weeks

  2. Diastolic Blood Pressure (mm Hg)

    Time frame: At baseline, 4-weeks, 8-weeks

  3. Fasting Blood Glucose (mg/dL)

    Time frame: Baseline, 4-weeks, 8-weeks

    Measured in serum

  4. Low Density Lipoprotein Cholesterol (mg/dL)

    Time frame: Baseline, 4-weeks, 8-weeks

    Measured in serum

  5. Body Mass Index (kg/m^2)

    Time frame: Baseline, 4-weeks, 8-weeks

    Derived from baseline height, and serial weight measurements

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • Harvard Medical School (HMS and HSDM)
  • Massachusetts General Hospital
  • Rheumatology Research Foundation

Registry information

Official study title

Dietary Approaches to Stop Hypertension (DASH) Diet Effects on Serum Uric Acid (SUA) in Adults With Hyperuricemia and Gout

Acronym: DIGO

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 26, 2018
Registry last updated
Mar 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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