The Diet Gout Trial

NCT03569020 | Completed Results

• 1 other identifier: IRB00153409
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Uric Acid Level

  Measured in serum

  Baseline

• Uric Acid Level

  Measured in serum

  At 4-weeks

• Uric Acid Level

  Measured in serum

  At 8-weeks

Secondary Outcomes (5)

• Systolic Blood Pressure (mm Hg)

  Baseline, 4-weeks, 8-weeks

• Diastolic Blood Pressure (mm Hg)

  At baseline, 4-weeks, 8-weeks

• Fasting Blood Glucose (mg/dL)

  Baseline, 4-weeks, 8-weeks

• Low Density Lipoprotein Cholesterol (mg/dL)

  Baseline, 4-weeks, 8-weeks

• Body Mass Index (kg/m^2)

  Baseline, 4-weeks, 8-weeks

Study Arms (2)

Dietitian-Directed Diet

EXPERIMENTAL

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

Self-Directed Diet

NO INTERVENTION

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

Interventions

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.

Dietitian-Directed Diet

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18-100 years
• Self-reported gout diagnosis
• Serum Uric Acid \> 7 mg/dL

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Massachusetts General Hospital: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Harvard Medical School (HMS and HSDM): collaborator
• Rheumatology Research Foundation: collaborator

Study Sites (2)

Johns Hopkins ProHealth Research Clinic

Woodlawn, Maryland, 21207, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• 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.

  PMID: 33186448 DERIVED

• 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.

  PMID: 32933342 DERIVED

MeSH Terms

Conditions

Gout; Hyperuricemia; Body Weight; Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Limitations and Caveats

There may have been carryover effects from the interventions on the primary outcome (serum urate). We were not adequately powered to rule out carry over effects, using a period-by-intervention interaction term in our models.

Results Point of Contact

• Title: Dr. Stephen Juraschek
• Organization: Beth Israel Deaconess Medical Center

sjurasch@bidmc.harvard.edu

617-754-1416

Study Officials

• Edgar Miller

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators will not know which assignment the participants were given. The laboratory measuring uric acid will not know which intervention the participants were assigned.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: June 26, 2018
• Study Start: August 7, 2018
• Primary Completion: July 23, 2019
• Study Completion: July 23, 2019
• Last Updated: March 30, 2021
• Results First Posted: March 30, 2021

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)