The effect of flour from the rind of the yellow passion fruit on glycemic control of people with diabetes mellitus type 2: a randomized clinical trial.

BACKGROUND

The single or combined use of herbal and dietary products with medications has shown benefits in the metabolic modulation of carbohydrates, in the restoring of the function of pancreatic beta cells, and in insulin resistance. To analyze the effect of the use of flour made from the rind of the yellow passion fruit on the glycemic control of people with diabetes mellitus type 2.

METHODS

An open, prospective, randomized clinical trial was undertaken with 54 participants over an eight-week period. The participants from the case group were advised to ingest 12 g of the flour, three times daily; before breakfast, lunch and dinner.

RESULTS

After eight weeks of use of the flour made from the rind of the yellow passion fruit, we did not identify significant statistical differences in the values for capillary blood glucose (p = 0.562), fasting blood glucose (p = 0.268) or glycated hemoglobin (p = 0.229) between the study groups. In the case group, we identified an increase (29.6%-37%) of the people with normal HbA1c; however, this did not have statistical relevance (p = 0.274).

CONCLUSIONS

Based in our findings, we believe it is important to extend the time of exposure to the intervention and increase the rigor in the monitoring of adherence in future studies on this topic. Only in this way will we be able to make confident inferences in relation to the use of flour made from the rind of theyellow passion fruit as a therapeutic tool for glycemic and/or metabolic control in persons with DM 2.

CONCLUSIONS

In the sample in question, the use of the flour made from the rind of the yellow passion fruit, over an eight-week period, did not improve the glycemic control of people with type 2 diabetes. Trial registration: U1111.1187.3616. Registered 6 September, retrospectively registered, in the Brazilian Clinical Trials Registry.