Phytate Decreases Formation of Advanced Glycation End-Products in Patients with Type II Diabetes: Randomized Crossover Trial
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Interventional (Human) Studies
84
Enhanced Details
Methods
Randomized single-center crossover trial in adults with type 2 diabetes mellitus treated at Hospital Son Llàtzer in the Balearic Islands, Spain. Thirty-five subjects were randomized and 33 completed the clinical study; the intervention groups were balanced 1:1 and each participant received both diet periods.
Intervention
Participants received phytate, specifically 1 capsule of 380 mg calcium-magnesium IP6 orally three times daily with each main meal for 12 weeks per diet period. The trial used a randomized crossover design comparing the IP6 diet with the same diet without IP6, separated by a 12-week washout.
Results
IP6 supplementation was associated with a favorable short-term reduction in glycation markers. After 3 months on the IP6 diet, HbA1c decreased from 7.8 ± 0.1% to 7.5 ± 0.1% (p = 0.029) and AGEs decreased from 7.8 ± 0.4% to 5.8 ± 0.3% (p < 0.001); these changes were not seen on the non-IP6 diet. After the washout/follow-up period, HbA1c and AGEs rose again in the IP6 period, suggesting the effect was treatment-dependent rather than durable. The regimen was reported as well tolerated, with no adverse safety signals and no impairment of iron status.
Limitations
The study was small, single-center, and used a short 12-week treatment period in a crossover design, which limits precision and generalizability. Follow-up was brief, and several secondary metabolic outcomes showed mostly no significant between-arm differences, with some results reported only in tables. Blinding was not stated in the provided packet, so expectation bias cannot be excluded.
Abstract
No abstract available