A multicenter clinical study with myo-inositol and alpha-lactalbumin in Mexican and Italian PCOS patients
Main article: Getting pregnant with PCOS
Women with PCOS are commonly prescribed Metformin and thiazolidinediones, to treat this disorder, however both drugs have adverse side-effects.
Myo-inositol on the other hand is a natural dietary supplement which also exerts an insulin sensitizing action with no reported side-effects at therapeutic doses.
Various studies investigating the effect of myo-inositol in women with PCOS found that 28-38% of women failed to respond satisfactorily to treatment. This resistance to inositol is attributed to reduced or absent intestinal absorption caused by unknown factors.
Alpha-lactalbumin is a milk protein previously shown to increase the passage of steroids or metals (i.e. iron) through biological membranes. In two recent studies, the addition of alpha-lactalbumin was shown to increase the intestinal absorption of myo-inositol, in vitro and in vivo, however the human trial group was small (n=14) requiring further studies to confirm the preliminary findings.
To evaluate the effect of myo-inositol and alpha-lactalbumin treatment in a group of Mexican and Italian patients affected by PCOS.
A total of 67 patients from Mexico (n = 26) and Italy (n = 41) were assessed for study inclusion. All women were aged 18-40 years old, with PCOS (Rotterdam ESHRE-ASRM definition) and insulin resistance.
Following assessment women identified with other causes of ovulatory disorders or excess androgen production, body mass index ≥ 30, certain medications, changes in diet / physical activity and previous inositol treatment (within 3 months) were automatically excluded from the study to minimise potential bias.
In total, 37 anovulatory women with PCOS satisfied the inclusion exclusion criteria for this study and were given sachets, each containing 2g of myo-inositol, 50mg alpha-lactalbumin and 200µg of folic acid, to take twice a day, 30 minutes before food, for a total of 6 months.
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.
Of the 37 participants, 33 completed the study, with 14 women from Mexico and 20 from Italy.
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 all higher in the Mexican group, whilst glucose, LH, and free testosterone was higher among the Italian women.
Post-trial 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, down 0.3 to 0.6 kg/m2. Interestingly this improvement in BMI was greater the further participants BMI was from normal.
Likewise progesterone levels, monitored monthly for ovulation, increased significantly up to satisfactory levels by the 3rd month, and was maintained to the end of the study, with final levels up 13 to 17.5 ng/ml.
Next primary study outcomes; insulin, glucose and HOMA-index also improved significantly by the end of the 3rd month, across both groups. This trend continued to the very end, with the exception of blood sugar (glucose) levels in the Mexican women.
LH and FSH levels generally improved however only LH significantly decreased (-4.7 IU/L) in the Italian group, while only FSH significantly decreased (-2.1 IU/L) in the Mexican group.
Likewise markers of androgen levels; total testosterone, free testosterone and androstenedione, showed statistically significant reductions by the 3rd month, continuing on a downward trend to the very end, with androstenedione levels significantly decreased further compared to the 3rd month.
|Total testosterone (nmol/L)||-27||-25|
|Free testosterone (nmol/L)||-1.1||-1.1|
Similarly total cholesterol, low density lipoprotein (LDL) and triglycerides significantly improved in both groups after 3 months of treatment, maintained to the end, while no real change in high density lipoprotein (HDL) levels was seen.
|Total cholesterol (mmol/L)||-33||-38|
|Low density lipoprotein (mmol/L)||-13||-10|
|High density lipoprotein (mmol/L)||+2||+3|
Reported side effects were rare with only 2 Mexican women experiencing occasional episodes of nausea/vomiting or abdominal colic.
The authors noted that the improvement following myo-inositol, alpha-lactalbumin and folic acid treatment was greater the further away baseline parameters were from normal in all participants.
SUMMARY: HOW ALPHA-LACTALBUMIN BENEFITS PCOS
Women with PCOS taking myo-inositol (2g), alpha-lactalbumin (50mg) and folic acid (200µg) supplements combined observed a loss in weight, decreased androgen levels, improved lipid profile and increased progesterone levels, back to normal indicating a resumption in ovulation, and improved fertility.
- No control group
- Small study size
No external funding was declared for this study.
Homeostatic Model Assessment for insulin resistance.
An experiment performed outside the living organism usually within a laboratory.
A medical test or experiment that is done on a whole living organism.
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
Ovulation disorders are very common and present in 18-25% of couples who see a specialist for infertility treatment. In the general population…. Read more
Polycystic ovary syndrome is a common endocrine condition that affects how a woman’s ovaries work. Described as a low-grade chronic…. Read more