Effect of Consumption of Cape Gooseberries on blood glucose control among patients with type 2 diabetes mellitus in Kampala, Uganda : a protocol for a randomized controlled trial

Abstract

Purpose: This study seeks to examine the efficacy of Cape gooseberries (Physalis peruviana) in regulating blood glucose levels, contributing to diabetes management. By exploring this cost-effective treatment option, this study could inform public health policies, empower communities to use local resources for managing chronic diseases, and encourage further studies on indigenous foods, ultimately enhancing the understanding of their potential to prevent diseases and promote health. Patients and Methods: A 12-week randomized controlled trial will be conducted with 200 diabetic patients recruited from St. Francis Nsambya and Mulago hospital diabetes clinics. The intervention group will consume 80 grams of fresh gooseberry per day in addition to regular diet and the control group will only consume their regular diet. Fasting blood glucose (FBG) will be assessed at baseline and bi-weekly, while the glycated haemoglobin (HbA1c) levels will be assessed at baseline, 6 weeks and 12 weeks. Adherence will be assessed through food intake diaries, bi-weekly group meetings, and Short Message Service (SMS) reminders. Statistical analysis will be conducted using SPSS. Descriptive statistics will summarize baseline characteristics for both theintervention and control arms. Independent t-tests will compare differences between the intervention and control arms. A p-value of <0.05 will be considered statistically significant. The primary outcomes are change in the levels of FBG and HbA1c levels. The secondary outcomes are rates of adherence and reported side effects. Discussion: The study is expected to provide evidence that daily consumption of Cape gooseberries improves FBG and HbA1c in patients with T2DM. Positive results could support the integration of indigenous fruit into the dietary recommendations, offering a potentially less expensive strategy for T2DM management and inform future research and public health interventions.