Table 4.
Summary of adverse events in all randomized participants
| All events (n people/N events) | Control (n = 30) | Multimodal lifestyle intervention (n = 32) | Multimodal lifestyle intervention + medical food (n = 31) |
|---|---|---|---|
| Adverse events | 15/25 | 9/11 | 12/22 |
| Musculoskeletal and connective tissue disorders | 6/6 | 3/3 | 5/5 |
| Fall | 1/1 | 0 | 1/1 |
| Cardiac disorders | 2/2 | 1/1 | 0 |
| Vascular disorders | 1/1 | 0 | 1/1 |
| Respiratory, thoracic, and mediastinal disorders | 1/1 | 3/3 | 2/2 |
| Gastrointestinal disorders | 4/4 | 2/2 | 3/3 |
| Psychiatric disorders | 2/2 | 0 | 2/4 |
| Skin and subcutaneous tissue disorders | 2/3 | 1/2 | 2/2 |
| Renal and urinary disorders | 1/1 | 0 | 3/3 |
| Reproductive system and breast disorders | 0 | 0 | 1/1 |
| Dental and gingival conditions | 1/1 | 0 | 0 |
| General disorders and administration site conditions/Investigations | 3/3 | 0 | 0 |
| Serious adverse events | 1/1 | 3/3 | 1/1 |
| Musculoskeletal and connective tissue disorders | 0 | 1/1 | 0 |
| Vascular disorders | 0 | 1/1 | 1/1 |
| Respiratory, thoracic, and mediastinal disorders | 0 | 1/1 | 0 |
| Renal and urinary disorders | 1/1 | 0 | 0 |
Data show number of participants / number of events. Some participants reported more than one event. (Serious) adverse events are presented by Medical Dictionary for Regulatory Activities preferred term. Adverse events were recorded at the 6-month visit in all participants, and also the 3-month visit in the two intervention arms. Participants were also asked if they had experienced any harm related to the study, such as stress or musculoskeletal pain