Trials / Not Yet Recruiting
Not Yet RecruitingNCT07209046
Impact of Probiotic (UltraFlora® Triplebiotic) on Weight Evolution on People After Discontinuation of GLP-1 Treatment.
A Randomized, Double-blind, Double-arm Study Conducted Directly With Consumers Via an App "Baritastic App", Evaluating the Efficacy of a Supplement Containing Bifidobacterium Lactis B420 and Pasteurized Akkermansia Muciniphila (UltraFlora® Triplebiotic) for 3 Months in Adults After Discontinuation of GLP-1 Treatment.
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 128 (estimated)
- Sponsor
- Metagenics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This is a randomized, double-blind, double arm study involving 128 participants who will undergo a total participation period of 12 weeks.
Detailed description
The trial begins with a screening to assess eligibility, followed by a 12-week treatment phase during which participants will receive a fixed-dose oral supplementation regimen. During this treatment period, participants will take UltraFlora® Triplebiotic at a fixed dose of 2 capsule per day, administered orally once daily with food. During the 12-week treatment period, participants will be asked to complete questions and track their weight changes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | UltraFlora® Triplebiotic | The duration of trial intervention and participation for an individual participant is approximately 3 months (12 weeks). Screening, during which eligibility to participate in the trial is assessed, occurs at baseline. A fixed, orally administered, dose of probiotic ( UltraFlora® Triplebiotics, 2 capsules/day) are taken daily with a glass of water. |
| DIETARY_SUPPLEMENT | Placebo | The duration of trial intervention and participation for an individual participant is approximately 3 months (12 weeks). Screening, during which eligibility to participate in the trial is assessed, occurs at baseline. A fixed, orally administered, dose of placebo (2 capsule/day) are taken daily with a glass of water. |
Timeline
- Start date
- 2025-11-01
- Primary completion
- 2026-06-30
- Completion
- 2026-07-31
- First posted
- 2025-10-06
- Last updated
- 2025-10-06
Source: ClinicalTrials.gov record NCT07209046. Inclusion in this directory is not an endorsement.