Effect of Probiotics Among Overweight and Obese Saudi Adults

Phase 3

Completed

• Conditions: Obesity; Adult
• Interventions: Dietary Supplement: Placebo; Drug: Probiotic

• Registration Number: NCT05667038
• Lead Sponsor: King Saud University

Brief 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.

Detailed Description

This study expects that the multi-strain probiotic product will induce beneficial changes in gut microbiota including reduction in weight, especially the visceral fat, which leads to reduction in systemic inflammatory state associated with fat accumulation. In order to evaluate the changes, ninety adult Saudi overweight or obese adult will be enrolled in this clinical trial and randomized to receive daily placebo or probiotics "MCP® BCMC® strains" for 12 weeks in a double-blind study. Biochemical markers will be measured through blood samples analyzed. Measurements and samples will be obtained at baseline and by the end of the study, at 12 weeks of treatment.

Study Timeline

• Study Start: 2022-03-03
• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2022-12-24
• Study First Posted: 2022-12-28
• Primary Completion: 2023-08-03
• Study Completion: 2023-08-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Adult's male and female ages between 19 to 40 years.
2. BMI (in kg/m2) from 25 to 35, (WHO, n. d.) Waist Circumference (WC) > 88 cm (women) or > 102 cm (men) (lean et al, 1995).
3. Stable body weight in the previous month of the trial.

Exclusion Criteria

• Participants who suffer from diseases and on treatment, such as immune system diseases or thyroid disorders.
• Pregnant women or who plans to be pregnant.
• Participants who had gastrointestinal surgery.
• Hormone replacement therapy.
• Participants who taking antibiotic.
• Participants who consume probiotic or prebiotic supplementation regularly.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo arm	Placebo	The placebo sachets containing only the excipients, i.e., maize starch and maltodextrins, weights 3g. The placebo was indistinguishable in color, smell, and taste from the probiotic formulation.
Probiotic arm	Probiotic	Drug being used is Hexbio sachet containing 3g / 90 billion CFU. this drug is a formulation containing six microorganism strains (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).

Primary Outcome Measures

Name	Time	Method
waist circumference	3 months	The primary outcome in this study is the difference in waist circumference between groups.

Trial Locations

Locations (1)

King Saud University; 🇸🇦 Riyadh, Saudi Arabia