Weight and Metabolic Management Study

This study will evaluate elénzia CONTROL®, a multi-ingredient nutritional supplement, in adults who are managing their weight either without previous use of glucagon-like peptide-1 (GLP-1) receptor agonists or following recent discontinuation of GLP-1 therapy. GLP-1 receptor agonists are increasingly used for weight management; however, weight regain following discontinuation is common. Although nutritional and lifestyle support is recommended as part of ongoing weight management, evidence remains limited on specific nutritional strategies for supporting weight maintenance following discontinuation of GLP-1 therapy. For adults who have not previously used GLP-1 medications, nutritional approaches targeting physiological pathways involved in appetite regulation and metabolic function may also offer a means of supporting weight management. The study therefore includes two distinct populations: adults who have never used GLP-1 receptor agonists and adults who have recently discontinued GLP-1 therapy. These populations will be evaluated separately to account for their different weight-management contexts and expected responses. elénzia CONTROL® combines nutritional ingredients selected to target multiple physiological pathways relevant to weight and metabolic health, including pathways involved in appetite regulation, glucose and lipid metabolism, hepatic metabolic function, and thyroid hormone synthesis. Individual components of the formulation have previously been investigated in human studies; however, the complete elénzia CONTROL® formulation has not previously been evaluated in a controlled clinical trial. This study therefore represents the first formal clinical evaluation of the combined formulation in these populations. The primary aim is to determine the effect of elénzia CONTROL® supplementation on body weight over 16 weeks. In participants who have never used GLP-1 receptor agonists, the study will investigate whether supplementation supports weight reduction. In participants who have recently discontinued GLP-1 therapy, it will investigate whether supplementation helps prevent weight regain following discontinuation. The study will also examine broader changes that may be relevant to weight management and participants' overall experience. These include appetite, sugar cravings, mood, energy, dietary intake, sleep, physical activity, stress, weight-related quality of life, and waist circumference. Together, these measures are intended to provide a broader understanding of changes occurring during the study alongside changes in body weight. The study will be conducted remotely, allowing participants to take part from their usual home environment. Study activities will be managed digitally through a mobile application, including informed consent, study questionnaires, self-reported measurements, supplement-use recording, and ongoing study monitoring. This decentralised approach is intended to evaluate the intervention under conditions that reflect its intended real-world use while maintaining the methodological features of a randomised, double-blind, placebo-controlled clinical trial.