Abstract
Background
Women living with type 2 diabetes mellitus (T2DM) often encounter unique physiological and lifestyle-related hurdles that impact disease progression and management. Dietary interventions tailored to cultural and gender-specific needs are essential for effective diabetes management.
Aim
This pilot trial primarily evaluated feasibility and safety and, secondarily, explored the preliminary metabolic effects and practical implementation of a lacto-vegetarian diet combined with intermittent fasting in Indian women with T2DM.
Methods
In this 12-week, parallel-group, open-label randomized controlled trial, 10 women with T2DM (aged 25–60 years) were randomly allocated in a 1:1 ratio using block randomization to either an intervention group (lacto-vegetarian diet within a 10-h eating window) or a control group (usual diet). Glycemic, lipid, and anthropometric parameters were measured at baseline and after the intervention. Safety, tolerability, and participant-reported experiences were also assessed.
Results
Exploratory within-group analyses in the intervention arm demonstrated reductions in glycated hemoglobin (−11.3%), fasting insulin (−47.4%), body weight (−3.96.0%), and body mass index (−3.98%) while the control group showed no meaningful changes. Lipid parameters showed no meaningful changes. No serious adverse events occurred; mild fatigue, hypoglycemia, and constipation were reported but resolved without intervention. Participants expressed improvements in energy, appetite control, and emotional well-being. No reductions in diabetes medication were reported, likely due to the short duration of the intervention.
Conclusion
This pilot randomized controlled trial was feasible, safe, and well-tolerated and showed signals of potential metabolic benefit in women with T2DM. This pilot study is part of an ongoing clinical trial, and the complete results will be presented upon completion of the full trial.
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