[Hot Science] Clinical Trial: Mediterranean diet with extra-virgin olive oil and use of glucose-lowering medications

Study Design and Method

• Subjects were adults free of cardiovascular disease who had either type 2 diabetes or at least three major cardiovascular risk factors with no glucose-lowering medication use at enrollment (N = 3,230), randomized to the following interventions:
  • Extra Virgin Olive Oil (EVOO) group (N = 2543)
    • Mediterranean diet
    • 1 L per week of EVOO given and at least 4 tablespoons/day intake recommended
    • Dietary training done by dietitians at baseline and quarterly
  • Mixed Nuts group (N = 2454)
    • Mediterranean diet
    • 30 g per day of mixed nuts given  
    • Dietary training done by dietitians at baseline and quarterly
  • Control (N = 2450)
    • General diet with advice on low-fat intake
    • Small nonfood gift given
    • Dietary training done by dietitian at baseline, thereafter, low-fat diet leaflet

Data collection

• Three sets of questionnaires were administered at randomization and yearly thereafter
  • A general medical questionnaire
  • A validated food frequency questionnaire
  • A validated physical activity questionnaire
• Time-to-event analyses were performed for two outcomes
  • Introduction of the first glucose-lowering medication (oral or injectable)
  • Insulin initiation

Result

• After a median follow-up of 3.2 years,
  • When compared with control group, the adjusted hazard ratios of starting a first glucose-lowering medication were,
    • 0.78 (95% CI, 0.62-0.98) for EVOO group
    • 0.89 (95% CI, 0.71-1.12) for Mixed Nuts group
• After a median follow-up of 5.1 years,
  • When compared with control group, the adjusted hazard ratios of insulin initiation were,
    • 0.87 (95% CI, 0.68-1.11) for EVOO group
    • 0.89 (95% CI, 0.69-1.14) for Mixed Nuts group

Conclusion

A Mediterranean diet with extra-virgin olive oil may delay the introduction of new-onset glucose-lowering medications among those with type 2 diabetes. However, a Mediterranean diet did not result in a significantly lower need for insulin.

Link to Publication: https://www.ncbi.nlm.nih.gov/pubmed/31182491

Reference

Basterra-Gortari et al. Diabetes Care. 2019;42:1390-1397.
 

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