Effect of Probiotics Among Overweight and Obese Saudi Adults

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05667038
• Other study ID #: E-20-5503
• Status: Completed
• Phase: Phase 3
• Start date: March 3, 2022
• Est. completion date: August 30, 2023

Study information

• Verified date: October 2023
• Source: King Saud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 30, 2023
• Est. primary completion date: August 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adult
• Obesity
• Overweight

Intervention

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.

Locations

Country	Name	City	State
Saudi Arabia	King Saud University	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	waist circumference	The primary outcome in this study is the difference in waist circumference between groups.	3 months