Weight and Metabolic Management Study

Elenzia200 enrolled

Overview

The goal of this clinical trial is to learn whether elénzia CONTROL®, a nutritional supplement, can support weight management in adults who have either never used GLP-1 weight-loss medications or have recently stopped using them. The main question it aims to answer is: Does taking elénzia CONTROL® for 16 weeks help reduce body weight in adults who have never used GLP-1 medications or help prevent weight regain in adults who have recently stopped using them? The study will also look at changes in appetite, sugar cravings, mood, energy, diet, sleep, physical activity, stress, quality of life, and waist circumference. Researchers will compare elénzia CONTROL® with a placebo (a look-alike supplement that does not contain the active ingredients) to see whether elénzia CONTROL® has an effect on weight management. Participants will: Take two capsules of elénzia CONTROL® or placebo once a day, 30 minutes before their largest meal, for 16 weeks. Use a mobile app to record whether they have taken their capsules and complete study questionnaires and assessments. Measure and report their body weight and waist circumference throughout the 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.

Interventions

elénzia CONTROL®DIETARY_SUPPLEMENT

elénzia CONTROL® is a commercially available multi-ingredient dietary supplement containing Eriomin® (lemon flavonoids including eriocitrin), bitter melon extract (10:1), SILIPHOS® (silybin-phosphatidylcholine complex), choline bitartrate, chromium picolinate, zinc bisglycinate chelate, iodine, and selenium. The formulation used in the study is identical to the commercially available product but is repackaged into white opaque capsules with study-specific labelling to maintain blinding. Participants will take two capsules orally once daily, 30 minutes before their largest meal, for 16 weeks.

PlaceboDIETARY_SUPPLEMENT

The placebo consists of microcrystalline cellulose (MCC), gluten-free rice bran, Nu-FLOW® (rice-derived silica), and E150a food-grade caramel colour. It is encapsulated in white opaque capsules that are visually identical in colour, size, and shape to the active supplement and packaged with study-specific labelling to maintain blinding. Participants will take two capsules orally once daily, 30 minutes before their largest meal, for 16 weeks.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults aged 25 to 65 years inclusive at the time of consent. * Participants must fall into one of the following cohorts: * GLP-1-naïve cohort: individuals who have never used GLP-1 receptor agonist medications. * Post-GLP-1 cohort: individuals who have discontinued GLP-1 receptor agonist therapy, with the last injection taken prior to enrolment. * Body mass index (BMI), calculated using self-reported height and weight at screening: * GLP-1-naïve cohort: BMI ≥27 kg/m² and \<40 kg/m². * Post-GLP-1 cohort: BMI \<40 kg/m², with no lower BMI limit. * Participants entering the post-GLP-1 cohort must have been on a stable GLP-1 receptor agonist dose for at least 6 months and achieved at least 10% body-weight reduction prior to discontinuation. * Participants must be capable of providing informed consent independently and demonstrate understanding of the study requirements. * Participants must be willing and able to complete study procedures remotely through a mobile application, provide self-measured weight and waist circumference data, and take the allocated study capsules daily as instructed. * Participants must have access to a compatible smartphone, reliable internet access, and their own home weighing scale. Additional participant characteristics: A prior diagnosis of prediabetes, insulin resistance, or polycystic ovary syndrome (PCOS) may be self-reported at screening for study population characterisation and subgroup analyses. These conditions are not required for eligibility and do not determine inclusion in the study. Exclusion Criteria: * Previous or current use of elénzia CONTROL®. * Current smoking or use of nicotine-containing products. * Pregnancy or breastfeeding. * Known hypersensitivity or allergy to any component of elénzia CONTROL® or the placebo, including citrus flavonoids, milk thistle extract, bitter melon extract, iodine, zinc, selenium or chromium. * Current use of insulin, sulfonylureas (e.g. gliclazide, glimepiride), warfarin, lithium, amiodarone, high-dose iodine supplements. * Current use of herbal or other dietary supplements specifically intended for weight loss, appetite control, fat burning, or blood glucose regulation. * Current use of anorexigenic medications, including sibutramine, bupropion for weight-loss indication, liraglutide, topiramate, orlistat, fluoxetine when used for appetite suppression, cannabinoids, medroxyprogesterone, megestrol, or systemic corticosteroids used as appetite stimulants. * Diagnosis of type 1 or type 2 diabetes mellitus. * History of significant endocrine disorders, including Cushing's disease or Addison's disease. * Chronic illnesses that may significantly affect food intake, weight regulation or metabolic status, including active malignancy, advanced liver disease, renal failure or acquired immunodeficiency syndrome (AIDS). * Current participation in another interventional clinical trial, or participation in an interventional study within the previous 30 days.

Outcomes

Primary Outcomes

Percentage Change in Body Weight From Baseline to Week 16

Percentage change in body weight from baseline to Week 16, calculated from participant-reported body weight measured using home weighing scales. Body weight is recorded through the study app. Analyses will be conducted separately within the GLP-1-naïve and post-GLP-1 cohorts.

Time frame: Baseline to Week 16

Absolute Change in Body Weight From Baseline to Week 16

Absolute change in body weight from baseline to Week 16, calculated from participant-reported body weight measured using home weighing scales and recorded through the study app. Analyses will be conducted separately within the GLP-1-naïve and post-GLP-1 cohorts.

Time frame: Baseline to Week 16

Secondary Outcomes

Change in Overall Appetite Score Assessed Using a Digital Visual Analogue Scale (VAS)

Appetite over the previous week is assessed through the study mobile app using four digital Visual Analogue Scale (VAS) items measuring hunger, fullness, satisfaction, and prospective food consumption. Each item is scored from 0 to 100 using a percentage-based slider. Hunger and prospective food consumption are reverse-scored, and the overall appetite score is calculated as the mean of the four items: \[satisfaction + fullness + (100 - hunger) + (100 - prospective food consumption)\] / 4. The overall score ranges from 0 to 100, with higher scores indicating greater satiety/lower appetite and lower scores indicating greater appetite.