Trial Outcomes & Findings for Diet Interventions in Psoriatic Arthritis (NCT NCT04180904)
NCT ID: NCT04180904
Last Updated: 2026-06-29
Results Overview
Disease Activity in Psoriatic Arthritis (DAPSA) is a total of the 5 elements listed below to assess disease activity from both clinical and patient-reported data. The total score falls within a range to indicate level of disease activity: 0-4 = Remission (minimum); 5-14 = Low; 15-28 = Moderate; \>28 = High Disease Activity. There is no theoretical upper limit to the DAPSA score. Total DAPSA score = TJ (Tender Joints) + SJ (Swollen Joints) + CRP (C-reactive protein) + Activity + Pain 1. Tender Joints Count (0-68 joints) 2. Swollen Joints Count (0-66 joints) 3. CRP (mg/dl) 4. Patient's assessment of disease activity and pain: 1. How active was your rheumatic disease on average during the last week? Scale of 1-10 (Not Active -Active) 2. How would you describe the overall level of joint pain during the last week? Scale of 1-10 (None-Very Severe)
COMPLETED
NA
92 participants
12 weeks
2026-06-29
Participant Flow
92 were consented for the study, as some were in screening at the time enrollment closed and to account for dropouts.
Participant milestones
| Measure |
Mediterranean (MED) Diet
Primary goal was to promote healthy dietary pattern following MED dietary principle: abundant use of olive oil and nuts (food delivery), as well as fruits, vegetables, fish, legumes No calorie restriction
|
DASH-LC (Low Calorie) Diet
Primary goal was to lose weight following a low calorie, low fat Dietary Approaches to Stop Hypertension (DASH) diet Calories limited to 1200-1600 a day (based on age, sex, BMI and goal for weight loss)
|
Standard of Care (Control)
Non-personalized dietary advice about healthy diet principles (10 minutes meeting with a dietician)
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
31
|
|
Overall Study
COMPLETED
|
29
|
23
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Diet Interventions in Psoriatic Arthritis
Baseline characteristics by cohort
| Measure |
Standard of Care (Control)
n=31 Participants
Non-personalized dietary advice about healthy diet principles (10 minutes meeting with a dietician)
|
Total
n=92 Participants
Total of all reporting groups
|
Mediterranean (MED) Diet
n=31 Participants
Primary goal was to promote healthy dietary pattern following MED dietary principle: abundant use of olive oil and nuts (food delivery), as well as fruits, vegetables, fish, legumes No calorie restriction
|
DASH-LC (Low Calorie) Diet
n=30 Participants
Primary goal was to lose weight following a low calorie, low fat Dietary Approaches to Stop Hypertension (DASH) diet Calories limited to 1200-1600 a day (based on age, sex, BMI and goal for weight loss)
|
|---|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 13 • n=267 Participants
|
55 years
STANDARD_DEVIATION 13 • n=265 Participants
|
57 years
STANDARD_DEVIATION 13 • n=9 Participants
|
52 years
STANDARD_DEVIATION 13 • n=27 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=267 Participants
|
64 Participants
n=265 Participants
|
18 Participants
n=9 Participants
|
22 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=267 Participants
|
28 Participants
n=265 Participants
|
13 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
23 Participants
n=267 Participants
|
74 Participants
n=265 Participants
|
25 Participants
n=9 Participants
|
26 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Non-White
|
8 Participants
n=267 Participants
|
18 Participants
n=265 Participants
|
6 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 weeksDisease Activity in Psoriatic Arthritis (DAPSA) is a total of the 5 elements listed below to assess disease activity from both clinical and patient-reported data. The total score falls within a range to indicate level of disease activity: 0-4 = Remission (minimum); 5-14 = Low; 15-28 = Moderate; \>28 = High Disease Activity. There is no theoretical upper limit to the DAPSA score. Total DAPSA score = TJ (Tender Joints) + SJ (Swollen Joints) + CRP (C-reactive protein) + Activity + Pain 1. Tender Joints Count (0-68 joints) 2. Swollen Joints Count (0-66 joints) 3. CRP (mg/dl) 4. Patient's assessment of disease activity and pain: 1. How active was your rheumatic disease on average during the last week? Scale of 1-10 (Not Active -Active) 2. How would you describe the overall level of joint pain during the last week? Scale of 1-10 (None-Very Severe)
Outcome measures
| Measure |
Mediterranean (MED) Diet
n=31 Participants
Primary goal was to promote healthy dietary pattern following MED dietary principle: abundant use of olive oil and nuts (food delivery), as well as fruits, vegetables, fish, legumes No calorie restriction
|
DASH-LC (Low Calorie) Diet
n=30 Participants
Primary goal was to lose weight following a low calorie, low fat Dietary Approaches to Stop Hypertension (DASH) diet Calories limited to 1200-1600 a day (based on age, sex, BMI and goal for weight loss)
|
Standard of Care (Control)
n=31 Participants
Non-personalized dietary advice about healthy diet principles (10 minutes meeting with a dietician)
|
|---|---|---|---|
|
Change in Disease Activity in Psoriatic Arthritis (DAPSA)
|
-2.1 score on a scale
Interval -4.3 to 0.2
|
-6.5 score on a scale
Interval -10.4 to -2.6
|
-5.0 score on a scale
Interval -7.9 to -2.2
|
SECONDARY outcome
Timeframe: 24 weeksDisease Activity in Psoriatic Arthritis (DAPSA) is a total of the 5 elements listed below to assess disease activity from both clinical and patient-reported data. The total score falls within a range to indicate level of disease activity: 0-4 = Remission (minimum); 5-14 = Low; 15-28 = Moderate; \>28 = High Disease Activity. There is no theoretical upper limit to the DAPSA score. DAPSA = TJ (Tender Joints) + SJ (Swollen Joints) + CRP (C-reactive protein) + Activity + Pain 1. Tender Joints Count (0-68 joints) 2. Swollen Joints Count (0-66 joints) 3. CRP (mg/dl) 4. Patient's assessment of disease activity and pain: 1. How active was your rheumatic disease on average during the last week? Scale of 1-10 (Not Active -Active) 2. How would you describe the overall level of joint pain during the last week? Scale of 1-10 (None-Very Severe)
Outcome measures
| Measure |
Mediterranean (MED) Diet
n=31 Participants
Primary goal was to promote healthy dietary pattern following MED dietary principle: abundant use of olive oil and nuts (food delivery), as well as fruits, vegetables, fish, legumes No calorie restriction
|
DASH-LC (Low Calorie) Diet
n=30 Participants
Primary goal was to lose weight following a low calorie, low fat Dietary Approaches to Stop Hypertension (DASH) diet Calories limited to 1200-1600 a day (based on age, sex, BMI and goal for weight loss)
|
Standard of Care (Control)
n=31 Participants
Non-personalized dietary advice about healthy diet principles (10 minutes meeting with a dietician)
|
|---|---|---|---|
|
Change in Disease Activity in Psoriatic Arthritis (DAPSA)
|
-4.6 score on a scale
Interval -7.1 to -2.1
|
-7.2 score on a scale
Interval -10.3 to -4.2
|
-7.3 score on a scale
Interval -10.4 to -4.2
|
SECONDARY outcome
Timeframe: Varying times: (at Baseline) 0, 12, 24 Weeks-Psoriatic Arthritis Disease Impact- Psoriatic Arthritis Impact of Disease (PSAID). The PsAID is a measure developed by the European League Against Rheumatism (EULAR) and is composed of domains selected by an international group of patients with psoriatic arthritis. The questionnaire uses a weighted scoring system (weights were derived by patient impression of importance) and has a range of 0-10. A lower score indicates lower impact of disease from the patient perspective, and a score of 4 is considered a patient acceptable symptom state.
Outcome measures
| Measure |
Mediterranean (MED) Diet
n=31 Participants
Primary goal was to promote healthy dietary pattern following MED dietary principle: abundant use of olive oil and nuts (food delivery), as well as fruits, vegetables, fish, legumes No calorie restriction
|
DASH-LC (Low Calorie) Diet
n=30 Participants
Primary goal was to lose weight following a low calorie, low fat Dietary Approaches to Stop Hypertension (DASH) diet Calories limited to 1200-1600 a day (based on age, sex, BMI and goal for weight loss)
|
Standard of Care (Control)
n=31 Participants
Non-personalized dietary advice about healthy diet principles (10 minutes meeting with a dietician)
|
|---|---|---|---|
|
Patient Reported Outcomes-Psoriatic Arthritis Disease Impact
Week 12
|
-0.4 score on a scale
Interval -1.0 to 0.1
|
-0.9 score on a scale
Interval -1.6 to -0.2
|
-0.6 score on a scale
Interval -1.2 to 0.1
|
|
Patient Reported Outcomes-Psoriatic Arthritis Disease Impact
Week 24
|
-0.4 score on a scale
Interval -1.1 to 0.3
|
-1.6 score on a scale
Interval -2.3 to -0.9
|
-0.7 score on a scale
Interval -1.4 to 0.0
|
SECONDARY outcome
Timeframe: Varying times: (at Baseline) 0, 12, 24 Weeks-Fatigue- PROMIS (Patient-Reported Outcomes Measurement Information System) Fatigue (CAT) The PROMIS Fatigue scale assesses fatigue experience and impact of fatigue over 7 days. The instrument includes items on exhaustion and ability to function normally in physical, social, mental and family roles and activities. This instrument has good content validity and responsiveness in rheumatoid arthritis, a similar inflammatory arthritis. We will use the CAT (Computerized Adaptive Test) response instrument. PROMIS uses Item Response Theory (IRT) statistical model that links individual questions to a presumed underlying trait or concept of global health represented by all items in the scale; instruments are scored using item-level calibrations ("response pattern scoring") in an online tool (T-Score range 0-100, where 50 is the mean with a standard deviation of 10). Increasing score indicates higher level of fatigue.
Outcome measures
| Measure |
Mediterranean (MED) Diet
n=31 Participants
Primary goal was to promote healthy dietary pattern following MED dietary principle: abundant use of olive oil and nuts (food delivery), as well as fruits, vegetables, fish, legumes No calorie restriction
|
DASH-LC (Low Calorie) Diet
n=30 Participants
Primary goal was to lose weight following a low calorie, low fat Dietary Approaches to Stop Hypertension (DASH) diet Calories limited to 1200-1600 a day (based on age, sex, BMI and goal for weight loss)
|
Standard of Care (Control)
n=31 Participants
Non-personalized dietary advice about healthy diet principles (10 minutes meeting with a dietician)
|
|---|---|---|---|
|
Patient Reported Outcomes-Fatigue
Week 12
|
-3.3 t score
Interval -5.0 to -1.7
|
-1.2 t score
Interval -4.1 to 1.6
|
-2.3 t score
Interval -4.8 to 0.3
|
|
Patient Reported Outcomes-Fatigue
Week 24
|
-4.1 t score
Interval -6.5 to -1.7
|
-3.0 t score
Interval -5.9 to -0.2
|
-3.2 t score
Interval -5.8 to -0.6
|
SECONDARY outcome
Timeframe: Varying times: (at Baseline) 0, 12, 24 WeeksChanges in Weight; Weight\_kg; Weight and Height will be combined to report BMI in kg/m\^2; Body Mass Index (BMI) \_ wt/h²; The standard weight status categories associated with BMI ranges for adults are listed as; BMI Weight Status: Below 18.5 Underweight 18.5 - 24.9 Normal or Healthy Weight 25.0 - 29.9 Overweight 30.0 and Above Obese Accessed on 11/19/19, https://www.cdc.gov/healthyweight/assessing/bmi/adult\_bmi/index.html#Interpreted
Outcome measures
| Measure |
Mediterranean (MED) Diet
n=31 Participants
Primary goal was to promote healthy dietary pattern following MED dietary principle: abundant use of olive oil and nuts (food delivery), as well as fruits, vegetables, fish, legumes No calorie restriction
|
DASH-LC (Low Calorie) Diet
n=30 Participants
Primary goal was to lose weight following a low calorie, low fat Dietary Approaches to Stop Hypertension (DASH) diet Calories limited to 1200-1600 a day (based on age, sex, BMI and goal for weight loss)
|
Standard of Care (Control)
n=31 Participants
Non-personalized dietary advice about healthy diet principles (10 minutes meeting with a dietician)
|
|---|---|---|---|
|
Metabolic Profile-Weight
Week 24
|
-1.0 kg
Interval -2.6 to 0.6
|
-3.5 kg
Interval -5.8 to -1.2
|
-2.5 kg
Interval -4.2 to -0.8
|
|
Metabolic Profile-Weight
Week 12
|
-1.4 kg
Interval -2.6 to -0.2
|
-3.3 kg
Interval -4.8 to -1.8
|
-2.0 kg
Interval -3.3 to -0.8
|
SECONDARY outcome
Timeframe: Varying times: (at Baseline) 0, 12, 24 WeeksWaist measurement\_cm
Outcome measures
| Measure |
Mediterranean (MED) Diet
n=31 Participants
Primary goal was to promote healthy dietary pattern following MED dietary principle: abundant use of olive oil and nuts (food delivery), as well as fruits, vegetables, fish, legumes No calorie restriction
|
DASH-LC (Low Calorie) Diet
n=30 Participants
Primary goal was to lose weight following a low calorie, low fat Dietary Approaches to Stop Hypertension (DASH) diet Calories limited to 1200-1600 a day (based on age, sex, BMI and goal for weight loss)
|
Standard of Care (Control)
n=31 Participants
Non-personalized dietary advice about healthy diet principles (10 minutes meeting with a dietician)
|
|---|---|---|---|
|
Metabolic Profile-Waist Measurement
|
-2.5 cm
Interval -4.0 to -1.0
|
-2.2 cm
Interval -4.4 to 0.0
|
-2.6 cm
Interval -4.1 to -1.1
|
Adverse Events
Mediterranean (MED) Diet
DASH-LC (Low Calorie) Diet
Standard of Care (Control)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place