Weight and Metabolic Management Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-65
SponsorElenzia
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 25 to 65 years inclusive at the time of consent.
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.
GLP-1-naïve cohort: BMI ≥27 kg/m² and <40 kg/m².
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
elénzia CONTROL®
Dietary supplementelénzia 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
Dietary supplementThe 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.
Treatment groups
200 Participants
are divided into 4 treatment groupsGroup A: GLP-1-Naïve - elénzia CONTROL®Experimental treatment 1 intervention
Group B: GLP-1-Naïve - PlaceboPlacebo comparator 1 intervention
Group C: Post-GLP-1 - elénzia CONTROL®Experimental treatment 1 intervention
Group D: Post-GLP-1 - PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 162
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 16Secondary outcomes
1
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.
Time frame
Baseline and every 2 weeks through Week 162
Change in Sugar Cravings Assessed Using a Digital Visual Analogue Scale (VAS)
Sugar cravings over the previous week are assessed through the study mobile app using a single-item digital Visual Analogue Scale (VAS). Participants rate the strength of their craving for sugary foods using a percentage-based slider ranging from 0 (No craving) to 100 (Extreme craving). Higher scores indicate stronger sugar cravings. Change from baseline will be evaluated over the 16-week study period.
Time frame
Baseline and every 2 weeks through Week 163
Change in Overall Mood Assessed Using a Digital Visual Analogue Scale (VAS)
Overall mood over the previous week is assessed through the study mobile app using a single-item digital Visual Analogue Scale (VAS). Participants rate their overall mood using a percentage-based slider ranging from 0 (Very low) to 100 (Excellent mood). Higher scores indicate better overall mood. Change from baseline will be evaluated over the 16-week study period.
Time frame
Baseline and every 2 weeks through Week 164
Change in Energy Levels Assessed Using a Digital Visual Analogue Scale (VAS)
Perceived energy levels over the previous week are assessed through the study mobile app using a single-item digital Visual Analogue Scale (VAS). Participants rate their energy levels using a percentage-based slider ranging from 0 (Very low) to 100 (Very high). Higher scores indicate higher perceived energy levels. Change from baseline will be evaluated over the 16-week study period.
Time frame
Baseline and every 2 weeks through Week 16 Source ClinicalTrials.gov