OBJECTIVE: The aim of this study was to evaluate the combined effects of 5-aminolevulinic acid phosphate (ALA-P) and iron on the glycemic index in mildly hyperglycemic adults. METHODS: This double-blind, randomized placebo-controlled trial comprised 212 subjects (ages 35-70 y, fasting plasma glucose 105-125 mg/dL or hemoglobin (Hb)A1c 6.1%-7.1%). These participants were randomly assigned to four groups receiving either one of three doses of ALA-P and iron as sodium ferrous citrate (5 mg and 0.6 mg, 5 mg and 1.8 mg, or 15 mg and 1.8 mg, respectively) or a placebo, administered orally once a day over a 12-wk period. RESULTS: Fifteen mg ALA-P plus 1.8 mg iron decreased the fasting plasma glucose level (2.32 mg/dL, 95% confidence interval [CI], 0.24-4.42, P = 0.029), serum glycoalbumin (0.22%, 95% CI, 0.02-0.42; P = 0.031), and 2h-oral glucose tolerance test levels (14.2 mg/dL, 95% CI, 1.8-26.6; P = 0.025) more than the placebo. However, the levels of HbA1c, fasting insulin, serum 1,5-anhydro-d-glucitol, and Homeostasis Model of Assessment-Insulin Resistance showed no appreciable changes. The participant numbers with impaired glucose tolerance and impaired fasting glucose decreased in the highest dosage group of ALA-P plus iron compared with the placebo group. CONCLUSION: An oral intake of ALA would be a novel approach to prevent type 2 diabetes mellitus.
RCT Entities:
OBJECTIVE: The aim of this study was to evaluate the combined effects of 5-aminolevulinic acid phosphate (ALA-P) and iron on the glycemic index in mildly hyperglycemic adults. METHODS: This double-blind, randomized placebo-controlled trial comprised 212 subjects (ages 35-70 y, fasting plasma glucose 105-125 mg/dL or hemoglobin (Hb)A1c 6.1%-7.1%). These participants were randomly assigned to four groups receiving either one of three doses of ALA-P and iron as sodium ferrous citrate (5 mg and 0.6 mg, 5 mg and 1.8 mg, or 15 mg and 1.8 mg, respectively) or a placebo, administered orally once a day over a 12-wk period. RESULTS: Fifteen mg ALA-P plus 1.8 mg iron decreased the fasting plasma glucose level (2.32 mg/dL, 95% confidence interval [CI], 0.24-4.42, P = 0.029), serum glycoalbumin (0.22%, 95% CI, 0.02-0.42; P = 0.031), and 2h-oral glucose tolerance test levels (14.2 mg/dL, 95% CI, 1.8-26.6; P = 0.025) more than the placebo. However, the levels of HbA1c, fasting insulin, serum 1,5-anhydro-d-glucitol, and Homeostasis Model of Assessment-Insulin Resistance showed no appreciable changes. The participant numbers with impaired glucose tolerance and impaired fasting glucose decreased in the highest dosage group of ALA-P plus iron compared with the placebo group. CONCLUSION: An oral intake of ALA would be a novel approach to prevent type 2 diabetes mellitus.
Authors: Judith A Simcox; Thomas Creighton Mitchell; Yan Gao; Steven F Just; Robert Cooksey; James Cox; Richard Ajioka; Deborah Jones; Soh-Hyun Lee; Daniel King; Jingyu Huang; Donald A McClain Journal: Diabetes Date: 2014-10-14 Impact factor: 9.461