Effect of Probiotics Among Overweight and Obese Saudi Adults

Effect of Multi-Strain Probiotics as an Anti-Obesity Among Overweight and Obese Saudi Adults

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Adult
• Intervention / Treatment: Dietary supplement: Placebo; Drug: Probiotic

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 3

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 4545
    • King Saud University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo arm; 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.	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.
Experimental: Probiotic arm; 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).	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.; Other Names: (HEXBIO®) containing MCP® BCMC® strains

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
waist circumference	The primary outcome in this study is the difference in waist circumference between groups.	3 months

Collaborators and Investigators

• Sponsor: King Saud University
• Investigators: Principal Investigator: Hanan A Alfawaz, Prof, King Saud University

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2022
• Primary Completion (Actual): August 3, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 24, 2022
• First Posted (Actual): December 28, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: E-20-5503

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No