Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 15, 2023
Date Accepted: Nov 1, 2023
MMP-9 Testing of Golden Rice Cookies with P. crocatum Active Extract for Preventing Foot Ulcers in Diabetic Patients: Protocol for a Randomized Controlled Trial
ABSTRACT
Background:
Diabetic Foot Ulcer (DFU) significantly reduces the quality of life for patients, prolongs hospital stays, and is the cause of approximately 70,000 lower limb amputations globally each year. DFU can be prevented by optimizing blood sugar levels and preventing complications or treating peripheral neuropathy. Golden Rice has been proven to lower blood sugar levels due to its β-carotene content, and P. crocatum has been found to be effective in reducing the risk factors of DFU through biomolecular regulation because of its polyphenol content.
Objective:
This study aims to identify the effectiveness of P. crocatum cookies with Golden Rice as the main ingredient for preventing diabetic foot ulcers (DFU) through the regulation mechanism of matrix metalloproteinase-9.
Methods:
This study is an experiment clinical research that follows the randomized controlled trial (RCT) method and employs a single-blind design. The participants in the study are outpatients from primary health centers in Makassar who have been diagnosed with Diabetes Mellitus. The sample for the study will be chosen randomly and divided into two groups: the intervention group and the control group. The intervention group will be instructed to consume golden rice cookies enriched with the active extract of P. crocatum, while the control group will be given cookies without P. crocatum and golden rice. The participants will consume these cookies twice a day for a duration of 14 days. Both types of cookies will be packaged in identical packaging. The dependent variable in this study is the expression of MMP-9, which will be assessed at two time points: before the intervention (pre-test) and after the intervention (post-test). MMP-9 will be examined using the western blotting method.
Results:
Data collection was conducted between July and September 2023. Analysis of responses began in November 2023, with the publication of results expected by 2024.
Conclusions:
The results of this trial should help practitioners in selecting the optimal approach for improving diabetes self-management in therapeutic snacking of patients with Type 2 Diabetes Mellitus. Clinical Trial: International Registered Report Identifier (IRRID): TCTR20230502001
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