Table 5 Strategies for adverse events management according to the expected event

Food allergy reactions to the consumption of nuts (Group 1)

Known allergy to nuts is part of exclusion criteria in this trial. If cases of unknown allergy are discovered, we will ask participants to immediately stop intervention and provide proper treatment until complete cessation of symptoms.

Gastrointestinal symptoms

The registered nutritionist will be trained to adjust dietary counseling according to the symptoms reported.

Choking and/or suffocation events (both groups)

We will train researchers to assess oral motor abilities of participants to chew and swallow foods during the screening process, so to diminish the probability of choking and/or suffocation events. To those who experience such conditions during the trial period, it will be possible to chance culinary preparations as to facilitate intake, as mentioned previously as a second line of counseling.

Food poisoning (both groups)

Since this is a dietary intervention-based trial, there is a chance of food poisoning in the study. Hygienic food preparation procedures will be stimulated by the care providers throughout the intervention period. To reduce the risk of poisoning from mycotoxins usually found in raw peanuts (Group 1), we will ask farmers to provide a report to ensure mycotoxin safety levels before every purchase.

Events related to blood testing or to the participants’ baseline cardiovascular condition

Bruises or phlebitis or new episodes of myocardial infarction are also expected. In presence of new MI, it may be necessary to stop intervention during the hospitalization and recovery period.