Skip to main content
OpenTrials
Completed

NCT Number: NCT05667038

Effect of Probiotics 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Adult Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

King Saud University

Riyadh, 4545, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic

Drug

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

Placebo

Dietary Supplement

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.

Primary outcomes

  1. waist circumference

    Time frame: 3 months

    The primary outcome in this study is the difference in waist circumference between groups.

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 28, 2022
Registry last updated
Oct 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.