Impact of Probiotic (UltraFlora® Triplebiotic) on Weight Evolution on People After Discontinuation of GLP-1 Treatment.

Metagenics

Status: Not yet enrolling

Conditions: Adults; GLP-1

Treatments: Dietary Supplement: UltraFlora® Triplebiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07209046

GLO-NAM-2025-04

Details and patient eligibility

About

This is a randomized, double-blind, double arm study involving 128 participants who will undergo a total participation period of 12 weeks.

Full 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Providing written informed consent
2. Males and females of at least 18 years old
3. Body mass index (BMI) between 25 and 30 (including 25 and 30) (Weight: 25 < BMI < 30)
4. Having undergone treatment with GLP-1 for more than 3 months but for less than 1 year.
5. Having stopped GLP-1 treatment for a maximum of 4 weeks
6. Being willing to maintain stable dietary habits and physical activity levels throughout the trial period
7. Being willing not to introduce any other food supplements during the trial period (supplements used in the two weeks prior to enrolling in the trial and used consistently throughout are acceptable, except for probiotics).

Exclusion criteria

1. Being on GLP-1 treatment
2. Having had any type of bariatric surgery, or planned bariatric surgery during the period of trial participation.
3. Suffering from a severe chronic disease (e.g., cancer, HIV, hepatic or renal impairment, diabetes type I), inflammatory bowel disease (IBD), Coeliac Disease, and/or being immunocompromised.
4. Suffering from any uncontrolled endocrine disorder.
5. Having consumed any probiotic supplements in the 3 months prior to enrollment.
6. Having used any antibiotic treatment in the 3 months prior to enrollment.
7. Having a known allergy to the ingredients in the study product.
8. Being pregnant or lactating (breastfeeding) or trying to become pregnant.
9. Participating in an other clinical trial.
10. Suffering from dementia or inability to take the trial treatment in an appropriate way.
11. Taking UltraFlora® Triplebiotic or any similar product from competitors prior to trial participation

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 2 patient groups, including a placebo group

UltraFlora® Triplebiotic

Active Comparator group

Description:

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 the study products (UltraFlora® Triplebiotic, 2 capsules/day) are taken daily with breakfast.

Treatment:

Dietary Supplement: UltraFlora® Triplebiotic

Orally administration of 2 capsules/day of placebo

Placebo Comparator group

Description:

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 the placebo (2 capsules/day) are taken daily with breakfast.

Treatment:

Dietary Supplement: Placebo