NCT05440630

Brief Summary

The study's main objective is to investigate the effect of a probiotic (live bacteria), postbiotic (heat-treated bacteria) on obesity parameters.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

1.3 years

First QC Date

June 16, 2022

Last Update Submit

March 5, 2025

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Change in abdominal/visceral fat area

    Difference in abdominal visceral fat area on MRI from baseline (V1) to 4 months of product intake (V4) within and between groups.

    0 week to 16 week

Secondary Outcomes (10)

  • Change in abdominal subcutaneous fat area

    0 week to 16 week

  • Change in body composition

    0 week to 16 week

  • Change in body weight

    week 0, week 4, week 8, week 16

  • Change in BMI

    week 0, week 4, week 8, week 16

  • Change in waist circumference

    week 0, week 4, week 8, week 16

  • +5 more secondary outcomes

Study Arms (3)

Probiotic

EXPERIMENTAL

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.

Dietary Supplement: Probiotics

Postbiotic

EXPERIMENTAL

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.

Dietary Supplement: Postbiotic

Placebo

PLACEBO COMPARATOR

Participants in this arm will receive an equivalent placebo for 16 weeks.

Dietary Supplement: Placebo

Interventions

ProbioticsDIETARY_SUPPLEMENT

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.

Probiotic
PostbioticDIETARY_SUPPLEMENT

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.

Postbiotic
PlaceboDIETARY_SUPPLEMENT

Participants in this arm will receive an equivalent placebo for 16 weeks.

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects from 18 to 65 years old.
  • 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

You may not qualify if:

  • Diagnosed and pharmacologically-treated type 1 or type 2 diabetes
  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nois de Mexico S.A. de C.V.

Guadalajara, 45050, Mexico

Location

MeSH Terms

Conditions

Obesity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Joshue Covarrubia Esquer, Dr

    NOIS DE MEXICO S.A. DE C.V.

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2022

First Posted

July 1, 2022

Study Start

July 1, 2022

Primary Completion

October 30, 2023

Study Completion

October 30, 2023

Last Updated

March 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)