Effect of Probiotics Among Overweight and Obese Saudi Adults

NCT05667038 | Completed Phase 3

• 1 other identifier: E-20-5503
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Adult

Outcome Measures

Primary Outcomes (1)

• waist circumference

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

  3 months

Study Arms (2)

Placebo arm

PLACEBO COMPARATOR

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

Probiotic arm

EXPERIMENTAL

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

Interventions

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.

Also known as: (HEXBIO®) containing MCP® BCMC® strains

Probiotic arm

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.

Placebo arm

Eligibility Criteria

• Age: 19 Years - 40 Years
• Gender Eligibility Details: Male \& female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

King Saud University

Riyadh, 4545, Saudi Arabia

Location

MeSH Terms

Conditions

Obesity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Hanan A Alfawaz, Prof

  King Saud University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: 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.

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 28, 2022
• Study Start: March 3, 2022
• Primary Completion: August 3, 2023
• Study Completion: August 30, 2023
• Last Updated: October 4, 2023

Record last verified: 2023-10

Locations

SA (1)