OverweightNCT04897698
Probiotics for Weight Loss
A study testing LB001 in people with Overweight, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- LB001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteSweden
- Study dates
- 16 Oct 2021to 9 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 26.0 - 29,99 kg/m2
- 18-45 years old
- Willingness to lose weight
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet, Department of Clinical Science, Intervention and Technology
Huddinge, Stockholm County, 141 57
About this study
Official title: 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.
Read the 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
- Being tested
- LB001
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LB001Dietary supplement
Probiotics
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Four capsules containing rice flour will be given to the placebo group daily. Receives: Dietary Supplement: LB001 |
| Single dose | Experimental | 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. Receives: Dietary Supplement: LB001 |
| Double dose | Experimental | 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. Receives: Dietary Supplement: LB001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Weight will be measured in kilograms using a scale.
Measured: Baseline, 3-month follow-up
Weight change
Weight will be measured in kilograms using a scale.
Measured: Baseline, 6-month follow-up
Secondary outcomes (8)
Waist circumference
Participants waist circumference will be measured using a standard tape measure (in cm).
Measured: Baseline, 3-month follow-up
Waist circumference
Participants waist circumference will be measured using a standard tape measure (in cm).
Measured: Baseline, 6-month follow-up
HbA1c
Glycated hemoglobin A1c will be measured in blood (mmol/mol)
Measured: Baseline, 3-month follow-up
HbA1c
Glycated hemoglobin A1c will be measured in blood (mmol/mol)
Measured: Baseline, 6-month follow-up
HDL
High-density lipoproteins will be measured in plasma (mmol/L)
Measured: Baseline, 3-month follow-up
HDL
High-density lipoproteins will be measured in plasma (mmol/L)
Measured: Baseline, 6-month follow-up
Triglycerides
Triglycerides will be measured in plasma (mmol/L)
Measured: Baseline, 3-month follow-up
Triglycerides
Triglycerides will be measured in plasma (mmol/L)
Measured: Baseline, 9-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start16 Oct 2021
- Primary completion9 May 2022
- Study completion9 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- deFair Medical AB
- Responsible party
- Principal investigator, Emilia Hagman, Karolinska Institutet
- Investigators
- Emilia Hagman, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897698
- Sponsor's protocol ID
- 4-1326/2021
- Status last verified
- Mar 2023
- First submitted
- 18 May 2021
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37875559
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LB001 Study: Probiotics for Weight Loss: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04897698
- Acronym / sponsor ID
- 4-1326/2021
- Conditions
- Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- deFair Medical AB
- Study start
- 16 Oct 2021 (actual)
- Primary completion
- 9 May 2022 (actual)
- Study completion
- 9 May 2022 (actual)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: LB001Four capsules containing rice flour will be given to the placebo group daily. |
| Single dose | Experimental | Dietary Supplement: LB001Two 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. |
| Double dose | Experimental | Dietary Supplement: LB001Four 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI 26.0 - 29,99 kg/m2
- 18-45 years old
- Willingness to lose weight
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LB001Probiotics | Dietary supplement | Double dose, Placebo, Single dose |
Primary outcome
Weight change
Time frame: Baseline, 3-month follow-up
Weight will be measured in kilograms using a scale.
Weight change
Time frame: Baseline, 6-month follow-up
Weight will be measured in kilograms using a scale.
8 secondary outcomes
Waist circumference
Time frame: Baseline, 3-month follow-up
Waist circumference
Time frame: Baseline, 6-month follow-up
HbA1c
Time frame: Baseline, 3-month follow-up
HbA1c
Time frame: Baseline, 6-month follow-up
HDL
Time frame: Baseline, 3-month follow-up
HDL
Time frame: Baseline, 6-month follow-up
Triglycerides
Time frame: Baseline, 3-month follow-up
Triglycerides
Time frame: Baseline, 9-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Derived from this study: PubMed 37875559Danielsson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilia Hagman, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LB001 in people with Overweight, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight change (time frame: Baseline, 3-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04897698, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.