Weight and Metabolic Management Study

Sponsor
Elenzia
Study ID
NCT07789223
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 65 Years
Healthy Volunteers
Not accepted

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.
  • Placebo — DIETARY_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.

Study Details

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.

Key Dates

First listed
Aug 27, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GLP-1-Naïve - elénzia CONTROL®
    Participants who have never used GLP-1 receptor agonists will receive elénzia CONTROL® for 16 weeks.
  • Placebo Comparator: GLP-1-Naïve - Placebo
    Participants who have never used GLP-1 receptor agonists will receive placebo for 16 weeks.
  • Experimental: Post-GLP-1 - elénzia CONTROL®
    Participants who have recently discontinued GLP-1 receptor agonist therapy will receive elénzia CONTROL® for 16 weeks.
  • Placebo Comparator: Post-GLP-1 - Placebo
    Participants who have recently discontinued GLP-1 receptor agonist therapy will receive placebo for 16 weeks.

Primary Outcome Measure

Percentage Change in Body Weight From Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]

Central Contacts

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