Effects of Sea Grape-Derived Nanoliposome Product in Adults with Prediabetes: A Randomised Controlled Clinical Trial

Intervention arm: Sea grape derived nanoliposome product plus standard care (Diet, physical activity, and risk factor counselling) - Active ingredient: Caulerpa lentillifera extract - Formulation: Nanoliposome encapsulated oral capsules - Dose: 75 mg per kg body weight daily - Duration: 90 days - Mode: Oral administration - Setting: Primary care settings (Puskesmas) - Implementation strategies: The investigational product will be administered under the supervision of trained physicians at participating Puskesmas. The dose will be determined based on participant body weight and prescribed by the study physician in accordance with the protocol. All physicians involved in the study will receive standardised training prior to trial implementation, delivered approximately 2 to 4 weeks before commencement of participant enrolment. The training will be provided by an expert team comprising study investigators and experienced clinicians, including a diabetologist. The training will be conducted over approximately 14 to 15 hours across two days and will cover study procedures, inclusion and exclusion criteria, dosing protocols, participant safety monitoring, and study documentation requirements. The programme will include a practical component of approximately 3 to 4 hours to ensure competency in intervention delivery and study procedures. Training will be delivered in person at Universitas Airlangga Hospital, utilising its clinical trial facilities, and will be supported by structured training materials. All physicians will be provided with standard operating procedures to guide intervention delivery and ensure consistency across sites. Ongoing support and refresher guidance will be available throughout the study period as required. The trial will be conducted across three Puskesmas, each supported by a dedicated research nurse responsible for participant follow up, adherence monitoring using capsule counts and participant diaries, and coordination of study related activities.