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BACKGROUND: Diabetic foot ulcers (DFUs) present a formidable challenge to both patients and health care systems. DFUs significantly reduce the quality of life for patients, prolong hospital stays, and are the cause of approximately 70,000 lower limb amputations across the globe annually. Prevention of DFUs primarily involves the optimization of blood sugar levels and the effective management of complications, particularly peripheral neuropathy. Golden Rice has been proven to lower blood sugar levels due to its beta-carotene content, and Piper crocatum (P. crocatum) has been found to be effective in reducing the risk factors of DFUs through biomolecular regulation because of its polyphenol content. OBJECTIVE: The principal objective of this study is to identify the efficacy of P. crocatum-enriched cookies, with Golden Rice as their primary ingredient, in preventing DFUs. The evaluation will center on their impact on the expression of matrix metalloproteinase-9 (MMP-9), a pivotal factor in the development of DFUs. METHODS: This study is an experimental clinical research that follows the randomized controlled trial method and uses a single-blind design. The participants in the study are outpatients from primary health centers in Makassar, Indonesia, who have been diagnosed with diabetes mellitus. The sample for the study will be randomly selected and subsequently categorized into 2 groups: the intervention group and the control group. The intervention group consumes P. crocatum-enriched Golden Rice cookies, while the control group receives cookies without these additives. The participants from both groups will consume their respective cookies (packaged identically) twice a day for 14 days. The cookies will be prepared according to a modified recipe with an emphasis on low glucose content, resulting in 51 calories per cookie, comprising 1% carbohydrates, 6% fat, 4% cholesterol, and 4% fiber, excluding gluten, sugar, and salt. They will be baked at 158°C for 20 minutes. The process involves the addition of 20% Golden Rice and 10% P. crocatum ethanol extract, both prepared via maceration with 96% ethanol. The dependent variable in this study is the expression of gelatinases matrix metalloproteinase, to be assessed at 2 distinct time points-preintervention (pretest) and postintervention (posttest)-with the evaluation conducted through the western blotting method. RESULTS: The recruitment and testing phase started in January 2024. The study is scheduled to be completed by the end of March 2024. Data analysis will commence in April 2024, and the publication of the results is anticipated in the same year (2024). The study will report on the changes in primary data, encompassing gelatinases matrix metalloproteinase, as well as secondary data, including the ankle-brachial index, neuropathy score, and random blood glucose level. CONCLUSIONS: The findings of this trial are expected to significantly impact the selection of strategies by health care practitioners to enhance diabetes self-management, particularly in the domain of therapeutic snacking, for patients diagnosed with diabetes mellitus. TRIAL REGISTRATION: Thai Clinical Trials Registry TCTR20230502001; https://www.thaiclinicaltrials.org/show/TCTR20230502001. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/49940.
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<b>Background and Objective:</b> Biofilms as a bacterial defense are relatively more difficult to eradicate with antibiotics, thus pathogenic bacteria in their biofilm form can cause serious problems for human health. Lakum <i>(Causonis trifolia</i> L.) is an herbaceous plant with many biological activities, one of which is an antimicrobial compound containing flavonoids, squalene, nimbidin, saponins, anthocyanins, tannins, myricetin, others. This study aimed to determine the antibiofilm activity of Lakum leaf extract against<i> Staphylococcus aureus </i>bacteria and the active compounds that play a role in inhibiting monomicrobial biofilms. <b>Materials and Methods:</b> This research method was carried out with an <i>in vitro</i> experimental study design using observations of phytochemical screening test results and the effectiveness of Lakum leaf antibiofilm on<i> Staphylococcus aureus</i> through microplate reader readings that measure optical density values. <b>Results:</b> This study showed that Lakum leaves contain alkaloids, flavonoids, phenolics, polyphenols, tannins and saponins. In addition, Lakum leaves gave biofilm inhibitory activity in the middle and maturation phase with the highest concentration in 1% extract of 76.95±0.0007 and 72.85± 0.0003%, respectively. Meanwhile, the lowest concentration was 0.125% extract of 65.65±0.0001% in the middle phase and 59.71±0.0003% in the maturation phase. <b>Conclusion:</b> That Lakum leaves have biofilm inhibitory activity on <i>Staphylococcus aureus</i> with flavonoid compounds, tannins and polyphenols that work as active substances in inhibiting the biofilm formation.