Effect of Probiotics Among Overweight and Obese Saudi Adults

NCT05667038 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-10-04

No results posted yet for this study

Summary

Obesity is classified as a low-grade chronic and systemic inflammatory disease and results from complicated interactions between genes and environmental factors, which leads to many diseases and affects the quality of life. There are growing interests in the effectiveness of probiotics as a supplementation to treat obesity through regulating microbiota host metabolism. Probiotics may influence the interplays among gut, brain, adipose, and liver in a way leading to weight. Since limited studies have been conducted on human subjects, more investigation is needed in this field. Therefore, this study sheds light on the investigation of the anti-obesity effect of probiotic supplementation.

Conditions

Interventions

DRUG

Probiotic

The probiotics sachet contains a granular powder with 6 microorganism strains (30 × 109 CFU/gram): Lactobacillus acidophilus BCMC®12130, Lactobacillus casei subsp BCMC®12313, Lactobacillus lactis BCMC®12451, Bifidobacterium bifidum BCMC®02290, Bifidobacterium infantis BCMC®02129, and Bifidobacterium longum BCMC®02120. The drug is consumed orally, two sachets per day, by dissolving the sachet content in a glass of room-temperature water, one before breakfast and one before the last meal, for three months length.

DIETARY_SUPPLEMENT

Placebo

Placebo: Subjects in the placebo group will receive the placebo consisting of only the carrier of the probiotic product, that is maize starch and maltodextrins. The sachet is consumed orally, two sachets per day, by dissolving the sachet content in a glass of room-temperature water, one before breakfast and one before the last meal, for three months length.

Sponsors & Collaborators

  • King Saud University

    lead OTHER

Principal Investigators

  • Hanan A Alfawaz, Prof · King Saud University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-03
Primary Completion
2023-08-03
Completion
2023-08-30

Countries

  • Saudi Arabia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05667038 on ClinicalTrials.gov