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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| Beth Israel Deaconess Medical Center | OTHER |
| Harvard Medical School (HMS and HSDM) | OTHER |
| Rheumatology Research Foundation |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Edgar Miller | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins ProHealth Research Clinic | Woodlawn | Maryland | 21207 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33186448 | Derived | 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. | |
| 32933342 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dietitian-Directed Diet Then Self-Directed Diet | During the 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. 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. This is followed by 4-weeks of the self-directed diet (referent diet). During the self-directed diet, participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period. This is followed by the 4-week Dietitian-Directed Diet. |
| FG001 | Self-Directed Diet Then Dietitian-Directed Diet | During the self-directed diet, participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period. This is followed by the 4-week Dietitian-Directed Diet. During the 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
|
This was a crossover design. Baseline characteristics are presented by participants' period 1 assignment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dietitian-Directed Diet Then Self-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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Uric Acid Level | Measured in serum | This was a crossover design. All 43 participants underwent both interventions. The data is presented by first period assignment. | Posted | Mean | Standard Deviation | mg/dL | Baseline |
|
This was a crossover design of 2 interventions. Each intervention lasted about 4 weeks. Adverse events in response to the intervention were assessed at the end of each intervention period during an in-person visit. Thus adverse event surveillance was performed at 4 weeks and 8 weeks for each participant in the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stephen Juraschek | Beth Israel Deaconess Medical Center | 617-754-1416 | sjurasch@bidmc.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 29, 2018 | May 22, 2019 | ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jun 10, 2019 | Jul 11, 2019 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 20, 2019 | Jul 11, 2019 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D006073 | Gout |
| D033461 | Hyperuricemia |
| D001835 | Body Weight |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
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| OTHER |
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.
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Investigators will not know which assignment the participants were given. The laboratory measuring uric acid will not know which intervention the participants were assigned.
Measured in serum |
| Baseline, 4-weeks, 8-weeks |
| Low Density Lipoprotein Cholesterol (mg/dL) | Measured in serum | Baseline, 4-weeks, 8-weeks |
| Body Mass Index (kg/m^2) | Derived from baseline height, and serial weight measurements | Baseline, 4-weeks, 8-weeks |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| NOT COMPLETED |
|
| BG001 | Self-Directed Diet Then Dietitian-Directed Diet | Participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period. |
| BG002 | Total | Total of all reporting groups |
| mg/dL |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Self-Directed Diet Then Dietitian-Directed Diet | Participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period. |
|
|
| Primary | Uric Acid Level | Measured in serum | This was a crossover study. Data are presented by first period assignment. The 4-week results represent period 1. | Posted | Mean | Standard Deviation | mg/dL | At 4-weeks |
|
|
|
| Primary | Uric Acid Level | Measured in serum | This was a crossover design. Results are presented by period 1 assignment. The 8-week results represent the effect of the second period. | Posted | Mean | Standard Deviation | mg/dL | At 8-weeks |
|
|
|
| Secondary | Systolic Blood Pressure (mm Hg) | Posted | Mean | Standard Deviation | mm Hg | Baseline, 4-weeks, 8-weeks |
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| Secondary | Diastolic Blood Pressure (mm Hg) | Posted | Mean | Standard Deviation | mm Hg | At baseline, 4-weeks, 8-weeks |
|
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| Secondary | Fasting Blood Glucose (mg/dL) | Measured in serum | Posted | Mean | Standard Deviation | mg/dL | Baseline, 4-weeks, 8-weeks |
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| Secondary | Low Density Lipoprotein Cholesterol (mg/dL) | Measured in serum | Posted | Mean | Standard Deviation | mg/dL | Baseline, 4-weeks, 8-weeks |
|
|
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| Secondary | Body Mass Index (kg/m^2) | Derived from baseline height, and serial weight measurements | One person in the Dietitian-Directed Diet and then Self-Directed Diet did not provide a body mass index measurement during the follow-up visit. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline, 4-weeks, 8-weeks |
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | Self-Directed Diet | Participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period. | 0 | 43 | 0 | 43 | 0 | 43 |
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| D011686 |
| Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| Period 2 (8-weeks) |
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| Period 2 |
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| Period 2 |
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| Period 2 |
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| Period 1 |
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| Period 2 |
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