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Probiotics for Weight Loss

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
LB001
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Overweight

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Karolinska Institutet, Department of Clinical Science, Intervention and Technology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Single dose

Double dose

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

Weight change
Weight will be measured in kilograms using a scale.
Weight change
Weight will be measured in kilograms using a scale.

Secondary Outcome Measures

Waist circumference
Participants waist circumference will be measured using a standard tape measure (in cm).
Waist circumference
Participants waist circumference will be measured using a standard tape measure (in cm).
HbA1c
Glycated hemoglobin A1c will be measured in blood (mmol/mol)
HbA1c
Glycated hemoglobin A1c will be measured in blood (mmol/mol)
HDL
High-density lipoproteins will be measured in plasma (mmol/L)
HDL
High-density lipoproteins will be measured in plasma (mmol/L)
Triglycerides
Triglycerides will be measured in plasma (mmol/L)
Triglycerides
Triglycerides will be measured in plasma (mmol/L)

Full Information

First Posted
May 18, 2021
Last Updated
March 7, 2023
Sponsor
Karolinska Institutet
Collaborators
deFair Medical AB
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1. Study Identification

Unique Protocol Identification Number
NCT04897698
Brief Title
Probiotics for Weight Loss
Official Title
LB001 Study: Probiotics for Weight Loss: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 16, 2021 (Actual)
Primary Completion Date
May 9, 2022 (Actual)
Study Completion Date
May 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
deFair Medical AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Four capsules containing rice flour will be given to the placebo group daily.
Arm Title
Single dose
Arm Type
Experimental
Arm Description
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.
Arm Title
Double dose
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
LB001
Intervention Description
Probiotics
Primary Outcome Measure Information:
Title
Weight change
Description
Weight will be measured in kilograms using a scale.
Time Frame
Baseline, 3-month follow-up
Title
Weight change
Description
Weight will be measured in kilograms using a scale.
Time Frame
Baseline, 6-month follow-up
Secondary Outcome Measure Information:
Title
Waist circumference
Description
Participants waist circumference will be measured using a standard tape measure (in cm).
Time Frame
Baseline, 3-month follow-up
Title
Waist circumference
Description
Participants waist circumference will be measured using a standard tape measure (in cm).
Time Frame
Baseline, 6-month follow-up
Title
HbA1c
Description
Glycated hemoglobin A1c will be measured in blood (mmol/mol)
Time Frame
Baseline, 3-month follow-up
Title
HbA1c
Description
Glycated hemoglobin A1c will be measured in blood (mmol/mol)
Time Frame
Baseline, 6-month follow-up
Title
HDL
Description
High-density lipoproteins will be measured in plasma (mmol/L)
Time Frame
Baseline, 3-month follow-up
Title
HDL
Description
High-density lipoproteins will be measured in plasma (mmol/L)
Time Frame
Baseline, 6-month follow-up
Title
Triglycerides
Description
Triglycerides will be measured in plasma (mmol/L)
Time Frame
Baseline, 3-month follow-up
Title
Triglycerides
Description
Triglycerides will be measured in plasma (mmol/L)
Time Frame
Baseline, 9-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilia Hagman, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet, Department of Clinical Science, Intervention and Technology
City
Huddinge
State/Province
Stockholm
ZIP/Postal Code
141 57
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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Probiotics for Weight Loss

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