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This is a randomized, double-blind, double arm study involving 128 participants who will undergo a total participation period of 12 weeks.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UltraFlora® Triplebiotic | Active Comparator | 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. |
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| Orally administration of 2 capsules/day of placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UltraFlora® Triplebiotic | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| weight measurement | Evaluate the impact of UltraFlora Triplebiotic (containing Bifidobacterium Lactis B420 and pasteurized Akkermansia Muciniphila) on weight regain over 3 months after discontinuation of GLP-1. | From enrollment to the end of treatment at 12 weeks (90 days) |
| Measure | Description | Time Frame |
|---|---|---|
| IBS-SSS (Irritable Bowel Syndrome - Severity Scoring System) questionnaire | Evaluate the impact of UltraFlora Triplebiotic containing Bifidobacterium Lactis B420 and pasteurized Akkermansia Muciniphila on weight regain over 3 months after discontinuation of GLP-1. It is a visual analog scale ranging from 0 to 100 that allows the severity of patients' gastrointestinal symptoms to be assessed. The higher the score, the more pain the patient is experiencing. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of appetite (e.g., number of meals) and food cravings (e.g., snacking or food preferences) in seven questions. | How hungry were you today? How full do you feel right now? How many meals ? Did you think about your next meal when you finished your meal? How many craving did you have today? How strong is your desire to eat? How much food do you think you could eat right now? | From enrollment to the end of treatment at 12 weeks (90 days) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irfan Qureshi, MD | Contact | 800-843-9660 | trials@metagenics.com |
| Name | Affiliation | Role |
|---|---|---|
| Mieke Van Den Driessche, PhD | Metagenics, Inc. | Study Director |
| Irfan Qureshi, MD | Metagenics, Inc. | Principal Investigator |
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| Placebo | Dietary Supplement | 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. |
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| From enrollment to the end of treatment at 12 weeks (90 days) |
| SVS (Subjective Vitality Scale) questionnaire | Evaluate the impact of UltraFlora Triplebiotic containing Bifidobacterium Lactis B420 and pasteurized Akkermansia Muciniphila on vitality using the Subjective Vitality Scales (SVS) questionnaire. This questionnaire assesses a state of well-being and optimal functioning in relation to independence and physical and psychological health. Scores range from 1 (very low vitality) to 7 (optimal vitality). | From enrollment to the end of treatment at 12 weeks (90 days) |
| TFEQ-R18 (Three-Factor Eating Questionnaire - Revised 18 items) Questionnaire | Evaluate the impact of UltraFlora Triplebiotic containing Bifidobacterium Lactis B420 and pasteurized Akkermansia Muciniphila on Hunger, Appetite and Cravings using the TFEQ-R18 Questionnaire over the course of 90 days. The TFEQ-R18 is a psychometric questionnaire that assesses eating behaviors and attitudes toward food. There are three dimensions: CR = conscious restraint, UE = uncontrolled eating, EE = emotional eating. High scores in UE or EE indicate an increased risk of overeating, weight gain, or eating disorders. A high score in CR shows a strong desire to restrict intake, but this is sometimes associated with episodes of disinhibition if the restriction fails. | From enrollment to the end of treatment at 12 weeks (90 days) |
| Side effects experienced when taking the test product or placebo throughout the study (product tolerance) | Expressed any of the following symptoms: headache(s), rash(es), cough, changes in appetite, or other. | The proportion of participants at day 14 (T1), day 30 (T2), day 60 (T3), day 90 (T4), |
| patient satisfaction with product use and recommendation | Evaluate the impact of UltraFlora Triplebiotic containing Bifidobacterium Lactis B420 and pasteurized Akkermansia Muciniphila after 90 days. Is satisfied with the intervention ? Would recommend the product ? Would purchase the product ? | The proportion of participants that at day 90 (T4): |