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A diet for the treatment of gout

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21749
Enrollment
30
Registered
2020-09-15
Start date
2020-09-15
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout

Interventions

The dietary intervention is a whole food plant based diet and it will be offered as an individual counselling package of in total 3 hours divided between introduction session (60 minutes) and four con

Sponsors

Reade
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Diagnosis of gout confirmed by a rheumatologist (first or recurrent episode) based on the ACR criteria. • Hyperuricemia (? = 7 mg/dL (0.42 mmol/L) and ? = 6 mg/dL (0.36 mmol/L)) (2). • Waist circumference of ? = 102 cm and ? = 88 cm.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • 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 guideline gout 2013: https://www.nvr.nl/richtlijnen/nvr-richtlijnen-standpunten-en-zorgpaden/) including ?2 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, see appendix B). • Inability to be scheduled for counselling and measurement visits. • Psychiatric disease. • No informed consent.

Design outcomes

Primary

MeasureTime frame
Serum uric acid

Secondary

MeasureTime frame
cardiovascular risk, adherence, metabolic parameters, physical, mental and social health and costs

Contacts

Public ContactWendy Walrabenstein

Reade

w.walrabenstein@reade.nl+31658869219

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)