Secondary Analysis of RCT Reports Higher Baseline GI Symptom Severity in Women Across Most Domains

This study represents a secondary analysis of a randomized controlled trial conducted in New Zealand. The population consisted of 200 adults with increased cardiometabolic risk. The intervention involved a 12-week New Zealand-adapted Mediterranean diet and behavioral intervention. Follow-up duration was 12 weeks. The primary outcome assessed gastrointestinal symptom severity using the GSRS.

Specific details regarding the comparator group were not reported in the available data. Similarly, the study phase and publication type were not reported. The secondary outcomes included health-related quality of life assessed by SF-36 and the influence of participant characteristics on symptoms. No specific comparator intervention details were provided for this analysis.

Regarding main results, baseline gastrointestinal symptom severity scores were analyzed by gender. Women reported significantly higher baseline gastrointestinal symptom severity scores on average across all GSRS domains except reflux. Results showed p < 0.05. Effect size and absolute numbers were not reported. This indicates a statistically significant difference in baseline characteristics between genders.

Safety and tolerability data were not reported, including adverse events, serious adverse events, and discontinuations. No limitations were listed in the provided JSON structure. Practice relevance was not reported. Clinicians should interpret these baseline findings cautiously as they do not reflect intervention efficacy directly. The study highlights baseline demographic variations rather than treatment outcomes.