GoutDIGONCT03569020
The Diet Gout Trial
A study testing Subsidy for food purchases and dietitian education in people with Gout and Hyperuricemia, run by Johns Hopkins University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gout, Hyperuricemia
- What is being tested?
- Subsidy for food purchases and dietitian education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Aug 2018to 23 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18-100 years
- Self-reported gout diagnosis
- Serum Uric Acid > 7 mg/dL
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Johns Hopkins ProHealth Research Clinic
Woodlawn, Maryland, 21207
About this study
Official title: Dietary Approaches to Stop Hypertension (DASH) Diet Effects on Serum Uric Acid (SUA) in Adults With Hyperuricemia and Gout
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.
Read the 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.
- Conditions
- Gout, Hyperuricemia
- Being tested
- Subsidy for food purchases and dietitian education
- 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
- Medical subject headings
- Gout, Hyperuricemia, Body Weight, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subsidy for food purchases and dietitian educationOther
$105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uric Acid Level
Measured in serum
Measured: Baseline
Uric Acid Level
Measured in serum
Measured: At 4-weeks
Uric Acid Level
Measured in serum
Measured: At 8-weeks
Secondary outcomes (5)
Systolic Blood Pressure (mm Hg)
Measured: Baseline, 4-weeks, 8-weeks
Diastolic Blood Pressure (mm Hg)
Measured: At baseline, 4-weeks, 8-weeks
Fasting Blood Glucose (mg/dL)
Measured in serum
Measured: Baseline, 4-weeks, 8-weeks
Low Density Lipoprotein Cholesterol (mg/dL)
Measured in serum
Measured: Baseline, 4-weeks, 8-weeks
Body Mass Index (kg/m^2)
Derived from baseline height, and serial weight measurements
Measured: Baseline, 4-weeks, 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start7 Aug 2018
- Primary completion23 Jul 2019
- Study completion23 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Harvard Medical School (HMS and HSDM), Rheumatology Research Foundation
- Responsible party
- Sponsor
- Investigators
- Edgar Miller, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569020
- Sponsor's protocol ID
- IRB00153409
- Acronym
- DIGO
- Status last verified
- Nov 2019
- First submitted
- 14 Jun 2018
- Last updated
- 30 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33186448Miller 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.
PubMed 32933342
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Approaches to Stop Hypertension (DASH) Diet Effects on Serum Uric Acid (SUA) in Adults With Hyperuricemia and Gout
- ClinicalTrials.gov ID
- NCT03569020
- Acronym / sponsor ID
- DIGO / IRB00153409
- Conditions
- Gout, Hyperuricemia
- Keywords
- Diet, Nutrition, DASH, Gout, Hyperuricemia, Potassium, Uric acid, Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Harvard Medical School (HMS and HSDM), Rheumatology Research Foundation
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 23 Jul 2019 (actual)
- Study completion
- 23 Jul 2019 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Posted 30 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dietitian-Directed Diet | Experimental | Other: Subsidy for food purchases and dietitian educationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18-100 years
- Self-reported gout diagnosis
- Serum Uric Acid > 7 mg/dL
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Dietitian-Directed Diet |
Primary outcome
Uric Acid Level
Time frame: Baseline
Measured in serum
Uric Acid Level
Time frame: At 4-weeks
Measured in serum
Uric Acid Level
Time frame: At 8-weeks
Measured in serum
5 secondary outcomes
Systolic Blood Pressure (mm Hg)
Time frame: Baseline, 4-weeks, 8-weeks
Diastolic Blood Pressure (mm Hg)
Time frame: At baseline, 4-weeks, 8-weeks
Fasting Blood Glucose (mg/dL)
Time frame: Baseline, 4-weeks, 8-weeks
Low Density Lipoprotein Cholesterol (mg/dL)
Time frame: Baseline, 4-weeks, 8-weeks
Body Mass Index (kg/m^2)
Time frame: Baseline, 4-weeks, 8-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33186448Ghazi 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.
- Derived from this study: PubMed 32933342Miller 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edgar Miller principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subsidy for food purchases and dietitian education in people with Gout and Hyperuricemia, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uric Acid Level (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03569020, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.