Effect of Probiotics Among Overweight and Obese Saudi Adults

Sponsor

King Saud University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05667038

Collaborator

(none)

Enrollment

Location

Arms

17.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Adult	Drug: Probiotic Dietary Supplement: Placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The study is a 12-week, a single center, double-blind, placebo-controlled, randomized, trial, 90 overweight or first-class obese subjects will be divided equally into two groups, a probiotics group, and a placebo group.The study is a 12-week, a single center, double-blind, placebo-controlled, randomized, trial, 90 overweight or first-class obese subjects will be divided equally into two groups, a probiotics group, and a placebo group.

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 3, 2022

Anticipated Primary Completion Date :

Jan 26, 2023

Anticipated Study Completion Date :

Aug 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

waist circumference [3 months]
The primary outcome in this study is the difference in waist circumference between groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Adult's male and female ages between 19 to 40 years.
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).

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	King Saud University	Riyadh		Saudi Arabia	4545

Sponsors and Collaborators

King Saud University

Investigators

Principal Investigator: Hanan A Alfawaz, Prof, King Saud University

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Hanan A Alfawaz, Prof, King Saud University

ClinicalTrials.gov Identifier:

NCT05667038

Other Study ID Numbers:

E-20-5503

First Posted:

Dec 28, 2022

Last Update Posted:

Dec 28, 2022

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity

Overweight

Study Results

No Results Posted as of Dec 28, 2022