Clinical trial

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

Name

E-20-5503

Description

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.

Trial arms

Trial start

2022-03-03

Estimated PCD

2023-08-03

Trial end

2023-08-30

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

Probiotic arm

Other names:

(HEXBIO®) containing MCP® BCMC® strains

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.

Arms:

Placebo arm

Size

Primary endpoint

waist circumference

3 months

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}

Updated at

2023-10-04

1 organization

1 product

2 indications

Organization

Product

Indication

Indication