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Effect of Mediterranean diet combined with healthy food boxes on blood glucose levels of people with type 2 diabetes and low socioeconomic status: a randomized controlled trial

Effect of Mediterranean diet combined with healthy food boxes on blood glucose levels of people with type 2 diabetes and low socioeconomic status: a randomized controlled trial - Food Pharmacy trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57037
Enrollment
40
Registered
2024-10-08
Start date
2025-01-08
Completion date
Unknown
Last updated
2026-06-15

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

Conditions

Diabetes mellitus type 2 Non-insulin dependent diabetes

Interventions

Both groups will be recommended to follow the Mediterranean diet. Participants in the intervention group will receive weekly whole plant-based food boxes supplied from local farms in the South Holla

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Diagnosed T2D - BMI > 25 kg/m2 - Aged 18 - 75 years - Be living in Rotterdam South - Yearly income below 25.000 euro

Exclusion criteria

Exclusion criteria: - Pregnancy or lactation during the trial - Severe psychiatric disorders, use of antipsychotic drugs - Serious heart conditions such as: significant heart arrhythmia, unstable angina pectoris, decompensated congestive heart failure - Organ failure - Untreated hypothyroidism - End-stage renal failure - Carcinomas - Transplants, myocardial infarct, cerebrovascular accident, or any large-scale surgery within the last 3 months - Corticosteroid-induced diabetes (in patients still using corticosteroids) - Food allergies for the products delivered in the food boxes

Design outcomes

Primary

MeasureTime frame
Between-group difference in HbA1c (mmol/mol) from baseline to three months. HbA1c will be measured using routine clinical lab procedures.

Secondary

MeasureTime frame
- Anthropometry: Body weight and waist circumference - Cardiovascular risk factors: LDL cholesterol, total cholesterol, HDL cholesterol, triglycerides, fasting blood glucose and blood pressure, measured with routine lab procedures - Quality of life - Work productivity - Demographic variables, drug use, smoking and drinking habits, exercise and (diabetes) medication use - Food intake and adherence to the diet intervention (% used products of food boxes) - Patient satisfaction - Number of participants that drop out

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 21, 2026