Effect of Probiotics Among Overweight and Obese Saudi Adults

Phase

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

Treatment

Placebo

Probiotic

Clinical Study ID

NCT05667038

E-20-5503

Ages 19-40
All Genders
Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

Participants who suffer from diseases and on treatment, such as immune system diseasesor 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

Placebo

March 03, 2022

August 30, 2023

Study 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.

Connect with a study center

King Saud University
Riyadh, 4545
Saudi Arabia
Site Not Available

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