MON-180 - Real-World Clinical Experience of BAIBA+ABA Oral Combination Targeting UCP-1 and GLP-1 Pathways on Body Composition and Clinical Hyperandrogenism in Indian Women with Polycystic Ovary Syndrome: A Multicentre Observational Study

Background: Polycystic ovary syndrome (PCOS) affects 6-20% of reproductive-age women and is driven by insulin resistance (IR) and visceral adiposity. In South Asian populations, UCP-1 gene polymorphisms impair adaptive thermogenesis while downregulated GLP-1 signaling diminishes incretin-mediated insulin sensitization, reducing efficacy of conventional interventions. ADA, AACE, and Endocrine Society guidelines position diet and exercise as primary management pillars. Preclinical studies confirm, beta-aminoisobutyric acid (BAIBA), an exercise-induced myokine, upregulates UCP-1-mediated white adipose browning via PPARα signaling, while abscisic acid (ABA) enhances GLP-1 secretion through LANCL2 receptor activation, improving IR and reducing visceral fat. However, clinical validation in humans was PCOS absent. This study provides the first real-world clinical evidence of a BAIBA+ABA combination as adjunct to lifestyle modification in Indian women with PCOS.

Methods: This multicentre, prospective, observational clinical study enrolled 91 Indian women with PCOS (Rotterdam criteria) across clinical sites in India. Patients received oral BAIBA+ABA adjunct to dietary and exercise counselling for a mean period of 3.3 months. Primary outcomes were body weight & waist circumference (WC). Secondary outcomes included clinical response rates for hirsutism, menstrual irregularity, ovarian cysts, hormonal acne, alopecia, and acanthosis nigricans, assessed by treating gynecologists at baseline and post-treatment.

Results: Mean body weight decreased from 81.4 kg to 73.6 kg (7.8 kg, 9.5% reduction), exceeding the 5% threshold for metabolic benefit. Mean WC decreased from 48.4 to 44.8 cm (3.6 cm, 7.4% reduction), indicating reduced central adiposity. Symptom responder rates were: hirsutism 88.4% (46/52), irregular menstrual cycles 86.5% (71/82), hormonal acne 85.4% (41/48), ovarian cysts 83.3% (30/36), alopecia 82.3% (14/17), and acanthosis nigricans 80.0% (16/20). No adverse events were reported.

Conclusion: Adjunctive BAIBA+ABA supplementation targeting UCP-1 and GLP-1 targets produced clinically meaningful weight loss, visceral fat reduction, and high responder rates across hyperandrogenic and metabolic PCOS symptoms in Indian women. These findings provide the first clinical validation supporting UCP-1+GLP-1 upregulation as complementary to lifestyle modification, particularly in South Asian women with impaired thermogenesis and incretin signaling. Large scale-controlled trials with metabolic biomarkers are warranted.

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