Probiotics for Weight Loss

NCT ID: NCT04897698

Last Updated: 2023-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-16
• Study Completion Date: 2022-05-09

Brief Summary

This study will investigate a compound of probiotics and prebiotics in females and males with overweight with the aim to evaluate the effect on weight and metabolic markers.

The design is a three month randomized doubled-blinded, three-armed placebo-controlled trial of probiotics for weight loss. Normal dose (2 capsules á 0.4g per day) doubled dose (4 capsules á 0.4g per day), or placebo.

A second, non-blinded, phase with only the compound of probiotics and prebiotics, with tripple dose (6 capsuled á 0.4g per day), will be performed for individuals who had the compound in the first phase.

Detailed Description

Participants Total number of study participants will be 75-90, consisting of overweight men and women, 18-45 years of age.

Treatment Dietary supplement consisting of probiotic capsules called LB001. It contains strains of pediococcus (Bacterial family of Lactobacillaceae) and saccharomycetes (kingdom of Fungi and the division Ascomycota) with a concentration of 13 millions cfu/g. Other ingredients (including stabilization) include rice bran, vegetable L-Cystein, magnesium salts from vegetable fatty acids. The capsule shell is made of vegetable HydroxyPropylMetylCellulosa (HPMC). Each capsule has a weight of 0.4 gram. The placebo is made of rice flour.

Since one of the inclusion criteria is "willingness to lose weight", all study participants, regardless of randomized treatment, will receive general advice regarding healthy lifestyle habits.

Conditions

Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Four capsules containing rice flour will be given to the placebo group daily.

Group Type: PLACEBO_COMPARATOR

LB001

Intervention Type: DIETARY_SUPPLEMENT

Probiotics

Single dose

Two capsules of probiotics and two capsules of placebo daily. Probiotic capsules contains strains of pediococcus (Bacterial family of Lactobacillaceae) and saccharomycetes (kingdom of Fungi and the division Ascomycota) with a concentration of 13 millions cfu/g. Other ingredients (including stabilization) include rice bran, vegetable L-Cystein, magnesium salts from vegetable fatty acids. The capsule shell is made of vegetable HydroxyPropylMetylCellulosa (HPMC). Each capsule has a weight of 0.4 gram.

The placebo is made of rice flour.

Group Type: EXPERIMENTAL

LB001

Intervention Type: DIETARY_SUPPLEMENT

Probiotics

Double dose

Four capsules of probiotics daily. Probiotic capsules contains strains of pediococcus (Bacterial family of Lactobacillaceae) and saccharomycetes (kingdom of Fungi and the division Ascomycota) with a concentration of 13 millions cfu/g. Other ingredients (including stabilization) include rice bran, vegetable L-Cystein, magnesium salts from vegetable fatty acids. The capsule shell is made of vegetable HydroxyPropylMetylCellulosa (HPMC). Each capsule has a weight of 0.4 gram.

Group Type: EXPERIMENTAL

LB001

Intervention Type: DIETARY_SUPPLEMENT

Probiotics

Interventions

LB001

Probiotics

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• BMI 26.0 - 29,99 kg/m2
• 18-45 years old
• Willingness to lose weight

Exclusion Criteria

• Active weight loss in the last three months
• The desire for or planned pregnancy upcoming months
• Chronic somatic diseases that may affect metabolic and/or intestinal function (e.g. diabetes, hypertension, dyslipidemia, Irritable Bowel Disorder (IBD), gluten intolerance, pancreatic dysfunction, other causes of malabsorption, neoplastic disease)
• Allergies with previous anaphylactic reactions
• Abdominal surgery six months prior to inclusion
• Current or history of eating disorders
• Extreme or unusual diets for the last three months, which the investigator considers could negatively affect the outcome of the study
• Psychiatric disorders (e.g., schizophrenia, and other diagnoses that may influence compliance)
• Drug or alcohol abuse
• Continuous oral pharmacological treatment and other types of pharmacological treatment that may influence the study
• Present or recent usage of other probiotic agents
• Other conditions which the investigator considers could negatively affect the outcome of the study or study compliance

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

deFair Medical AB

UNKNOWN

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Emilia Hagman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emilia Hagman, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Karolinska Institutet, Department of Clinical Science, Intervention and Technology

Huddinge, Stockholm County, Sweden

Countries

Sweden

References

Danielsson P, Putri RR, Marcus C, Hagman E. Evaluating probiotic efficacy on weight loss in adults with overweight through a double-blind, placebo-controlled randomized trial. Sci Rep. 2023 Oct 24;13(1):18200. doi: 10.1038/s41598-023-45395-7.

Reference Type: DERIVED

PMID: 37875559 (View on PubMed)

Other Identifiers

4-1326/2021

Identifier Type: -

Identifier Source: org_study_id