Polyphenol-rich cocoa in reducing diabetes-related pulmonary and vascular dysfunction: Protocol for a randomized controlled trial.

BACKGROUND

Pulmonary and vascular complications in diabetes remain highly prevalent and remain leading causes of morbidity and mortality, including sudden death. Recent studies suggest that therapies targeting low-grade inflammation and oxidative stress could halt the decline in pulmonary/vascular function in diabetes. One potential therapy is naturally occurring polyphenols. This study aims to investigate the potential pulmonary/vascular benefits of polyphenols in individuals with diabetes.

METHODS

This is a 2-arm, parallel, randomized controlled trial with 1:1 randomization, involving 100 participants per arm. Participants will receive either 500 mg of polyphenol (in 10 g of polyphenol-rich cocoa) per day for three months (intervention group) or an identical-appearing placebo once daily for three months, in addition to standard of care. Clinical, lifestyle, biochemical, pulmonary, microvascular, and macrovascular measures will be taken at baseline (week 0), and at weeks 4, 8, and 12 of treatment. The primary endpoint is the change in percentage predicted forced expiratory volume in 1 s (FEV1) from baseline to 12 weeks. Key secondary endpoints include changes in microvascular function and macrovascular function measures from baseline to 12 weeks. The changes in % predicted FEV1 and secondary endpoints over time will be analyzed using linear mixed-effects models with fixed effects for treatment group, time (baseline, 4, 8, and 12 weeks), and the treatment group-by-time interaction. Safety will be assessed descriptively, with the number (percentage) of participants experiencing (serious) adverse events summarized by treatment group.

CONCLUSION

This study will provide data on how polyphenol-rich cocoa differentially impacts pulmonary and vascular functions in diabetes.