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

Официальное название

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.

Обзор

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

Подробное описание

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.

Вмешательства

• Пищевая добавка 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.
• Пищевая добавка 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.

Первичные конечные точки

• weight measurement [Срок оценки: From enrollment to the end of treatment at 12 weeks (90 days)]

Вторичные конечные точки (3)

• IBS-SSS (Irritable Bowel Syndrome - Severity Scoring System) questionnaire [Срок оценки: From enrollment to the end of treatment at 12 weeks (90 days)]
• SVS (Subjective Vitality Scale) questionnaire [Срок оценки: From enrollment to the end of treatment at 12 weeks (90 days)]
• TFEQ-R18 (Three-Factor Eating Questionnaire - Revised 18 items) Questionnaire [Срок оценки: From enrollment to the end of treatment at 12 weeks (90 days)]

Критерии участия

Критерии включения

• Providing written informed consent
• Males and females of at least 18 years old
• Body mass index (BMI) between 25 and 30 (including 25 and 30) (Weight: 25 < BMI < 30)
• Having undergone treatment with GLP-1 for more than 3 months but for less than 1 year.
• Having stopped GLP-1 treatment for a maximum of 4 weeks
• Being willing to maintain stable dietary habits and physical activity levels throughout the trial period
• 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).

Критерии исключения

• Being on GLP-1 treatment
• Having had any type of bariatric surgery, or planned bariatric surgery during the period of trial participation.
• 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.
• Suffering from any uncontrolled endocrine disorder.
• Having consumed any probiotic supplements in the 3 months prior to enrollment.
• Having used any antibiotic treatment in the 3 months prior to enrollment.
• Having a known allergy to the ingredients in the study product.
• Being pregnant or lactating (breastfeeding) or trying to become pregnant.
• Participating in an other clinical trial.
• Suffering from dementia or inability to take the trial treatment in an appropriate way.
• Taking UltraFlora® Triplebiotic or any similar product from competitors prior to trial participation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07209046 · GLO-NAM-2025-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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