International Journal of Diabetes & its Complications
ISSN: 2573-8895 | DOI: 10.64030/2573-8895
Abeer Al Saweer, Fatima Al Alawi, Hanan Humaidan, Abdul Rasool Mahdi, Najat Abbas, Zainab Al Hasan, Sumaya Al Doseri, Ebtihaj Al Sitri, Taghreed Alyan, Rabha Salman, Amal Al Ghanim, Khawla Saad, Jaafar Abbas, Jameel Nasser, Motowo Nakajima, Tohru Tanaka, Aslam Sadiq and Riyadh Rehani
The primary objective of this study was to explore the safety and benefits of a nutritional supplement containing 100 mg of 5-aminolevulinic acid phosphate and 29 mg of sodium ferrous citrate (5-ALA phosphate/SFC) in patients with diabetes when administered in conjunction with standard-of-care hypoglycemic treatment. This post-marketing surveillance (PMS) study included 100 male and female diabetic patients from 14 healthcare centers in Bahrain, all of whom received 5-ALA phosphate/ SFC in addition to their routine diabetes medications. Outcomes were compared with data from 96 historical control patients who received standard-of-care treatment alone. Data were collected at 16-week intervals: pre-study (t0 –16 weeks), at treatment initiation (t0 ), at the end of treatment (t0 +16 weeks), and at post-treatment follow-up (t0 +32 weeks). Adverse events reported were either mild or unrelated to the supplement.
Patients receiving 5-ALA phosphate/SFC were categorized into four response classes based on changes in HbA1c levels: super- responders, responders, steady-responders, and non-responders. Statistically significant reductions in HbA1c were observed in both the super-responder and responder classes at post-treatment follow-up (p < 0.05). No abnormalities were noted in blood laboratory analyses post-treatment. Among non-responders, insulin was administered when oral hypoglycemic agents proved ineffective due to severe insulin resistance.
These findings provide evidence that 5-ALA phosphate/SFC is a safe and effective adjunct oral hypoglycemic supplement when used alongside standard-of-care treatments for diabetes. Further randomized, double-blind, placebo-controlled trials are warranted to confirm these findings. It was also postulated that 5-ALA phosphate/SFC upregulates mitochondrial function by enhancing heme production, which is important for the electron transport chain in the mitochondrial inner membrane. A follow-up study was also conducted to evaluate the supplement’s potential effect on mitochondrial activity, a factor often impaired in insulin-resistant individuals, particularly among super-responders