Clinical trials

This study will assess the impact of maternal moringa supplementation to mothers of breastfeeding infants on milk output, milk composition, exclusive breastfeeding duration, and maternal and child health. This will be accomplish by conducting a randomized, controlled dietary intervention study enrolling breastfeeding mothers and their newborn infants. Mothers will be randomized to receive either 10g dried moringa leaf powder in carrier vs. carrier alone, consumed daily for four months, with follow-up for 2 years. Women must be \>18 years of age, ≤ 30 days postpartum and exclusively breastfeeding at the time of enrollment. Infants must be at least 37 weeks of gestational age, be healthy and are able to feed orally and consume human milk. After randomization and enrollment, breast milk samples will be obtained at baseline, 2, 4, and 6 months. Serum from mothers will be collected at recruitment, 2, 6,and 9 months; infant serum will be collected by capillary sample at recruitment and approximately at 4, 6, 12, 18, and 24 months. Infant hemoglobin and infant feeding weights (test weights) will be collected on sequential days at recruitment, 4, and 6 months. 24-hour dietary recall: the foods and drinks consumed by mothers in the 24 hours prior to each milk sample. Other assessments will include perceptions of breastfeeding, assess complementary feeding practices. Review will be conducted of maternal and infant infections, diagnoses, and hospitalizations at the time of visit or since the last visit.

The investigator hypothesizes that treatment with the ß3 agonist mirabegron results in improved glucose metabolism, including a reversal of prediabetes in obese, insulin-resistant human research participants, and this is further improved by combination therapy with tadalafil. The investigator will comprehensively analyze glucose homeostasis in prediabetic patients treated for 14 weeks with mirabegron, tadalafil or both drugs as compared to a placebo.

Mirabegron (Myrbetriq®, Astellas) is a highly specific and well-tolerated ß3 agonist marketed for overactive bladder. This trial will assess the effects of mirabegron on glucose tolerance and adipose tissue in prediabetic patients