Study of Efficacy of a Probiotic and Postbiotic in Overweight and Obese Individuals
NCT ID: NCT05440630
Last Updated: 2025-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2022-07-01
2023-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Probiotic
Participants in this arm will receive a daily dose of 1x10\^10 Colony Forming Unit (CFU) of a single strain probiotic (live bacteria) for 16 weeks.
Probiotics
Participants in this arm will receive a daily dose of 1x10\^10 Colony Forming Unit (CFU) of a single strain probiotic (live bacteria) for 16 weeks.
Postbiotic
Participants in this arm will receive a daily dose of 1x10\^10 Colony Forming Unit (CFU) of a single strain probiotic (Heat treated bacteria) for 16 weeks.
Postbiotic
Participants in this arm will receive a daily dose of 1x10\^10 Colony Forming Unit (CFU) of a single strain postbiotic (Heat treated bacteria) for 16 weeks.
Placebo
Participants in this arm will receive an equivalent placebo for 16 weeks.
Placebo
Participants in this arm will receive an equivalent placebo for 16 weeks.
Interventions
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Probiotics
Participants in this arm will receive a daily dose of 1x10\^10 Colony Forming Unit (CFU) of a single strain probiotic (live bacteria) for 16 weeks.
Postbiotic
Participants in this arm will receive a daily dose of 1x10\^10 Colony Forming Unit (CFU) of a single strain postbiotic (Heat treated bacteria) for 16 weeks.
Placebo
Participants in this arm will receive an equivalent placebo for 16 weeks.
Eligibility Criteria
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Inclusion Criteria
Established diagnosis of overweight (BMI ≥ 25 and up to 34.9)
Waist circumference ≥ 102 cm for men
Waist circumference ≥ 88 cm for women
Signature of the informed consent letter.
Agreement to comply with the protocol and study restrictions
Exclusion Criteria
Subjects with serious autoimmune disease, cardiovascular disease, liver dysfunction/disease, kidney dysfunction/disease or chronic disease
Immunosuppression or ongoing therapy causing immunosuppression
Pharmacologically-treated (medication/supplements) hypertension or dyslipidaemia
Subjects consuming antibiotics in the previous 2 months
Subjects consuming probiotics and prebiotics at least 1 month prior to inclusion in the study or during the intervention period.
History of chronic active inflammatory disorders
History of bariatric surgery
History of any chronic gastrointestinal disease (e.g. IBD).
Known hypersensitivity to any ingredients in the active or placebo products.
18 Years
65 Years
ALL
Yes
Sponsors
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Nois de México
OTHER
The Archer-Daniels-Midland Company
INDUSTRY
Responsible Party
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Principal Investigators
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Joshue Covarrubia Esquer, Dr
Role: PRINCIPAL_INVESTIGATOR
NOIS DE MEXICO S.A. DE C.V.
Locations
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Nois de Mexico S.A. de C.V.
Guadalajara, , Mexico
Countries
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Other Identifiers
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PCTB202015
Identifier Type: -
Identifier Source: org_study_id
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