Health TrialsbyHealthPanel

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

ConditionsAdultsGLP-1
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMetagenics, Inc.

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: UltraFlora® TriplebioticActive comparator 1 intervention
Group B: Orally administration of 2 capsules/day of placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 12 weeks (90 days)

Secondary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 12 weeks (90 days)
2

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).

Time frame
From enrollment to the end of treatment at 12 weeks (90 days)
3

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.

Time frame
From enrollment to the end of treatment at 12 weeks (90 days)

Other outcomes

1

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?

Time frame
From enrollment to the end of treatment at 12 weeks (90 days)
2

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.

Time frame
The proportion of participants at day 14 (T1), day 30 (T2), day 60 (T3), day 90 (T4),
3

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 ?

Time frame
The proportion of participants that at day 90 (T4):

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Metagenics, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: