Trial Outcomes & Findings for The Diet Gout Trial (NCT NCT03569020)
NCT ID: NCT03569020
Last Updated: 2021-03-30
Results Overview
Measured in serum
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
43 participants
Primary outcome timeframe
Baseline
Results posted on
2021-03-30
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Period 1
STARTED
|
22
|
21
|
|
Period 1
COMPLETED
|
22
|
21
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
22
|
21
|
|
Period 2
COMPLETED
|
22
|
21
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Diet Gout Trial
Baseline characteristics by cohort
| Measure |
Dietitian-Directed Diet Then Self-Directed Diet
n=22 Participants
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.
|
Self-Directed Diet Then Dietitian-Directed Diet
n=21 Participants
Participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.5 mg/dL
STANDARD_DEVIATION 13.3 • n=5 Participants
|
60.5 mg/dL
STANDARD_DEVIATION 10.7 • n=7 Participants
|
59.0 mg/dL
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
21 participants
n=7 Participants
|
43 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: This was a crossover design. All 43 participants underwent both interventions. The data is presented by first period assignment.
Measured in serum
Outcome measures
| Measure |
Dietitian-Directed Diet Then Self-Directed Diet
n=22 Participants
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.
|
Self-Directed Diet Then Dietitian-Directed Diet
n=21 Participants
Participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period.
|
|---|---|---|
|
Uric Acid Level
|
8.23 mg/dL
Standard Deviation 0.74
|
8.03 mg/dL
Standard Deviation 0.79
|
PRIMARY outcome
Timeframe: At 4-weeksPopulation: This was a crossover study. Data are presented by first period assignment. The 4-week results represent period 1.
Measured in serum
Outcome measures
| Measure |
Dietitian-Directed Diet Then Self-Directed Diet
n=22 Participants
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.
|
Self-Directed Diet Then Dietitian-Directed Diet
n=21 Participants
Participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period.
|
|---|---|---|
|
Uric Acid Level
|
7.67 mg/dL
Standard Deviation 1.25
|
8.03 mg/dL
Standard Deviation 1.13
|
PRIMARY outcome
Timeframe: At 8-weeksPopulation: This was a crossover design. Results are presented by period 1 assignment. The 8-week results represent the effect of the second period.
Measured in serum
Outcome measures
| Measure |
Dietitian-Directed Diet Then Self-Directed Diet
n=22 Participants
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.
|
Self-Directed Diet Then Dietitian-Directed Diet
n=21 Participants
Participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period.
|
|---|---|---|
|
Uric Acid Level
|
7.75 mg/dL
Standard Deviation 1.15
|
7.98 mg/dL
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: Baseline, 4-weeks, 8-weeksOutcome measures
| Measure |
Dietitian-Directed Diet Then Self-Directed Diet
n=22 Participants
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.
|
Self-Directed Diet Then Dietitian-Directed Diet
n=21 Participants
Participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period.
|
|---|---|---|
|
Systolic Blood Pressure (mm Hg)
Baseline
|
125.0 mm Hg
Standard Deviation 17.0
|
123.5 mm Hg
Standard Deviation 12.4
|
|
Systolic Blood Pressure (mm Hg)
Period 1 (4-weeks)
|
126.4 mm Hg
Standard Deviation 15.2
|
123.7 mm Hg
Standard Deviation 14.2
|
|
Systolic Blood Pressure (mm Hg)
Period 2 (8-weeks)
|
129.4 mm Hg
Standard Deviation 17.2
|
124.8 mm Hg
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: At baseline, 4-weeks, 8-weeksOutcome measures
| Measure |
Dietitian-Directed Diet Then Self-Directed Diet
n=22 Participants
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.
|
Self-Directed Diet Then Dietitian-Directed Diet
n=21 Participants
Participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period.
|
|---|---|---|
|
Diastolic Blood Pressure (mm Hg)
Baseline
|
74.9 mm Hg
Standard Deviation 11.3
|
72.6 mm Hg
Standard Deviation 10.5
|
|
Diastolic Blood Pressure (mm Hg)
Period 1
|
76.1 mm Hg
Standard Deviation 11.9
|
75.0 mm Hg
Standard Deviation 11.8
|
|
Diastolic Blood Pressure (mm Hg)
Period 2
|
77.3 mm Hg
Standard Deviation 11.7
|
74.0 mm Hg
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: Baseline, 4-weeks, 8-weeksMeasured in serum
Outcome measures
| Measure |
Dietitian-Directed Diet Then Self-Directed Diet
n=22 Participants
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.
|
Self-Directed Diet Then Dietitian-Directed Diet
n=21 Participants
Participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period.
|
|---|---|---|
|
Fasting Blood Glucose (mg/dL)
Baseline
|
93.0 mg/dL
Standard Deviation 11.6
|
103.0 mg/dL
Standard Deviation 18.1
|
|
Fasting Blood Glucose (mg/dL)
Period 1
|
96.5 mg/dL
Standard Deviation 12.1
|
103.2 mg/dL
Standard Deviation 27.7
|
|
Fasting Blood Glucose (mg/dL)
Period 2
|
97.1 mg/dL
Standard Deviation 12.7
|
97.6 mg/dL
Standard Deviation 16.6
|
SECONDARY outcome
Timeframe: Baseline, 4-weeks, 8-weeksMeasured in serum
Outcome measures
| Measure |
Dietitian-Directed Diet Then Self-Directed Diet
n=22 Participants
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.
|
Self-Directed Diet Then Dietitian-Directed Diet
n=21 Participants
Participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period.
|
|---|---|---|
|
Low Density Lipoprotein Cholesterol (mg/dL)
Baseline
|
109.0 mg/dL
Standard Deviation 31.1
|
115.5 mg/dL
Standard Deviation 41.2
|
|
Low Density Lipoprotein Cholesterol (mg/dL)
Period 1
|
105.3 mg/dL
Standard Deviation 34.4
|
113.4 mg/dL
Standard Deviation 41.5
|
|
Low Density Lipoprotein Cholesterol (mg/dL)
Period 2
|
107.5 mg/dL
Standard Deviation 33.8
|
105.5 mg/dL
Standard Deviation 36.8
|
SECONDARY outcome
Timeframe: Baseline, 4-weeks, 8-weeksPopulation: 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.
Derived from baseline height, and serial weight measurements
Outcome measures
| Measure |
Dietitian-Directed Diet Then Self-Directed Diet
n=22 Participants
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.
|
Self-Directed Diet Then Dietitian-Directed Diet
n=21 Participants
Participants will be asked to consume their typical diet for 4 weeks. There will be no subsidy during this period.
|
|---|---|---|
|
Body Mass Index (kg/m^2)
Baseline
|
33.4 kg/m^2
Standard Deviation 6.4
|
33.5 kg/m^2
Standard Deviation 7.5
|
|
Body Mass Index (kg/m^2)
Period 1
|
33.0 kg/m^2
Standard Deviation 6.4
|
33.6 kg/m^2
Standard Deviation 7.8
|
|
Body Mass Index (kg/m^2)
Period 2
|
33.6 kg/m^2
Standard Deviation 6.5
|
33.5 kg/m^2
Standard Deviation 8.0
|
Adverse Events
Dietitian-Directed Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Self-Directed Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Stephen Juraschek
Beth Israel Deaconess Medical Center
Phone: 617-754-1416
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place