Probiotics for Weight Loss

LB001 Study: Probiotics for Weight Loss: A Randomized Controlled Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Overweight
• Intervention / Treatment: Dietary supplement: LB001

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm
    • Huddinge, Stockholm, Sweden, 141 57
      • Karolinska Institutet, Department of Clinical Science, Intervention and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Four capsules containing rice flour will be given to the placebo group daily.	Dietary supplement: LB001; Probiotics
Experimental: 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.	Dietary supplement: LB001; Probiotics
Experimental: 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.	Dietary supplement: LB001; Probiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight change	Weight will be measured in kilograms using a scale.	Baseline, 3-month follow-up
Weight change	Weight will be measured in kilograms using a scale.	Baseline, 6-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist circumference	Participants waist circumference will be measured using a standard tape measure (in cm).	Baseline, 3-month follow-up
Waist circumference	Participants waist circumference will be measured using a standard tape measure (in cm).	Baseline, 6-month follow-up
HbA1c	Glycated hemoglobin A1c will be measured in blood (mmol/mol)	Baseline, 3-month follow-up
HbA1c	Glycated hemoglobin A1c will be measured in blood (mmol/mol)	Baseline, 6-month follow-up
HDL	High-density lipoproteins will be measured in plasma (mmol/L)	Baseline, 3-month follow-up
HDL	High-density lipoproteins will be measured in plasma (mmol/L)	Baseline, 6-month follow-up
Triglycerides	Triglycerides will be measured in plasma (mmol/L)	Baseline, 3-month follow-up
Triglycerides	Triglycerides will be measured in plasma (mmol/L)	Baseline, 9-month follow-up

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: deFair Medical AB
• Investigators: Principal Investigator: Emilia Hagman, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID Numbers: 4-1326/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No