A pilot randomized controlled trial with a one-year extension period on the effect of a whole food plant-based diet for patients with gout

• Conditions: gewrichtsaandoeningen: jicht en metabool syndroom/hart- en vaatziekten; gout

• Registration Number: NL-OMON49186
• Lead Sponsor: Reade

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Diagnosis of gout confirmed by a rheumatologist (first or recurrent episode)
based on the ACR criteria (Neogi et al, 2015).
Hyperuricemia (* * 7 mg/dL (0.42 mmol/L) and * * 6 mg/dL (0.36 mmol/L))
(Duskin-Bitan et al., 2014).
Waist circumference of * * 102 cm and * * 88 cm.

Exclusion Criteria

- Concurrent presence of other forms of inflammatory joint disease than gout.
- Intractable gout due to side effects or contra-indications for standard flare
treatment (NSAIDs, colchicine and corticosteroids).
- Current use of urate lowering therapy or use of urate lowering therapy in the
last 30 days.
- Indication for urate lowering therapy according national guidelines (NVR gout
2013) including 2 or more flares in one year, tophaceous gout or history of
urate urolithiasis. Unless agreement between patient and treating
rheumatologist led to the decision to postpone the start of ULT for the
duration of at least the first 4 months of the study.
- Pregnancy.
- Insufficient comprehension of Dutch language.
- Already following a (near-)vegan diet.
- In case of smoking, unwillingness to stop smoking for at least the duration
of the study.
- Low e-health competencies (lowest proficiency according to Pharos quick scan)
- Inability to be scheduled for counselling and measurement visits.
- Psychiatric disease.
- No informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome for the RCT study is the difference in mean change in serum<br /><br>uric acid levels between intervention- and control groups. The primary outcome<br /><br>for the extension study is the within-subject mean change in serum uric acid<br /><br>levels from 0-16 months. </p><br>