A multicenter clinical study with myo-inositol and alpha-lactalbumin in Mexican and Italian PCOS patients
An open-label, non-randomized, clinical study was carried out to understand the combined effect of Alpha-lactalbumin (alpha-LA) and myo-inositol (MI) in a more diverse population of women with PCOS.
Previous studies show that 28 – 38% of women with PCOS fail to respond to MI treatment, as a consequence of reduced or absent intestinal absorption, however alpha-LA, a milk protein with low immunogenicity was recently found to help with this drawback.
To test this further, a total of 67 patients from Mexico (n = 26) and Italy (n = 41) were assessed for study inclusion. Women were aged 18 – 40 years old, with PCOS (Rotterdam ESHRE-ASRM definition) and insulin resistance. However women with other causes of ovulatory disorders or androgen hyper production, body mass index ≥ 30, certain medications, changes in diet / physical activity and previous inositols treatment (within 3 months) were excluded from the study.
Of the 67 women, 37 anovulatory women with PCOS met the inclusion exclusion criteria for the study, with 3 women dropping out part way through the study.
Primary study outcome was change in HOMA-index after 3 and 6 months of treatment. Changes in progesterone, luteinizing hormone (LH), follicle-stimulating hormone (FSH), total testosterone, free testosterone, androstenedione, total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and triglycerides were also monitored for secondary outcomes.
Participants were given sachets each containing 2g of MI, 50mg alpha-LA and 200 µg of folic acid, to take twice a day, 30 minutes before food, for a total of 6 months.
Baseline characteristics of the two groups (Mexico, Italy) showed statistically significant differences between them at the start of the study with BMI, progesterone, insulin, HOMA-index, and androstenedione higher in the Mexican women, whilst glucose, LH, and free testosterone was higher in the Italian women.
Following treatment, initial analysis showed a significant improvement in the BMI of both groups after 3 months of treatment, which improved further by the end of the 6th month. This improvement in BMI was greater the further participants BMI was from normal.
Likewise progesterone levels, monitored monthly for ovulation, increased significantly to satisfactory levels by the 3rd month, and maintained to the end of the study.
Primary study outcomes; insulin, glucose and HOMA-index also improved significantly by the end of month 3, in both groups with the exception of blood sugar (glucose) levels in the Mexican women.
LH and FSH levels generally improved (trend) however only LH significantly decreased in the Italian group, while only FSH significantly decreased in the Mexican group.
All markers of androgen levels; total testosterone, free testosterone and androstenedione, showed significant reductions by the 3rd month, continuing on a downward trend to the very end, with androstenedione levels further decreased significantly compared to month 3.
Similarly total cholesterol, LDL and triglycerides significantly improved in both groups after 3 months of treatment, maintained to the end, while no change in HDL levels was seen.
Reported side effects were rare with only 2 Mexican women experiencing occasional episodes of nausea/vomiting or abdominal colic.
Overall the improvement following MI, alpha-LA and folic acid treatment was greater the further away baseline parameters were from normal in all participants.
SUMMARY: How much inositol should I take for PCOS
According to this study 2g of myo-inositol, 50mg alpha-lactalbumin and 200µg of folic acid, taken twice a day, 30 minutes before food, for a period of 6 months, significantly improved important parameters of PCOS in patients characterised by different metabolic profiles.
- No control group
- Small study size
Boscaini S, et al. (2019). Dietary α-lactalbumin alters energy balance, gut microbiota composition and intestinal nutrient transporter expression in high-fat diet-fed mice. https://doi.org/10.1017/s0007114519000461
Monastra G, et al. (2018). Alpha-lactalbumin effect on Myo-inositol intestinal absorption: in vivo and in vitro. https://doi.org/10.2174/1567201815666180509102641
Olivia M M, et al. (2018). Effects of myo-inositol plus alpha-lactalbumin in myo-inositol-resistant PCOS women. https://doi.org/10.1186/s13048-018-0411-2
Yamaguchi M, et al. (2009). Novel functions of bovine milk-derived alpha-lactalbumin: anti-nociceptive and anti-inflammatory activity caused by inhibiting cyclooxygenase-2 and phospholipase A2. https://doi.org/10.1248/bpb.32.366
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