Recruiting
Not applicable
Weight and Metabolic Management Study
Condition(s) studied
OverweightObesityWeight Maintenance
Investigational drug(s) / intervention(s)
elénzia CONTROL®Placebo
elénzia CONTROL®: 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.
Placebo: 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.
Study summary
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.
Eligibility
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.
Primary outcome measure(s)
- Percentage Change in Body Weight From Baseline to Week 16 — 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.
- Absolute Change in Body Weight From Baseline to Week 16 — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Elénzia |
Redditch |
West Midlands |
Recruiting |
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