Probiotics for Weight Loss

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04897698
• Other study ID #: 4-1326/2021
• Status: Completed
• Phase: N/A
• Start date: October 16, 2021
• Est. completion date: May 9, 2022

Study information

• Verified date: March 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: May 9, 2022
• Est. primary completion date: May 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Weight Loss

Intervention

Dietary Supplement:
• LB001
Probiotics

Locations

Country	Name	City	State
Sweden	Karolinska Institutet, Department of Clinical Science, Intervention and Technology	Huddinge	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	deFair Medical AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight change	Weight will be measured in kilograms using a scale.	Baseline, 3-month follow-up
Primary	Weight change	Weight will be measured in kilograms using a scale.	Baseline, 6-month follow-up
Secondary	Waist circumference	Participants waist circumference will be measured using a standard tape measure (in cm).	Baseline, 3-month follow-up
Secondary	Waist circumference	Participants waist circumference will be measured using a standard tape measure (in cm).	Baseline, 6-month follow-up
Secondary	HbA1c	Glycated hemoglobin A1c will be measured in blood (mmol/mol)	Baseline, 3-month follow-up
Secondary	HbA1c	Glycated hemoglobin A1c will be measured in blood (mmol/mol)	Baseline, 6-month follow-up
Secondary	HDL	High-density lipoproteins will be measured in plasma (mmol/L)	Baseline, 3-month follow-up
Secondary	HDL	High-density lipoproteins will be measured in plasma (mmol/L)	Baseline, 6-month follow-up
Secondary	Triglycerides	Triglycerides will be measured in plasma (mmol/L)	Baseline, 3-month follow-up
Secondary	Triglycerides	Triglycerides will be measured in plasma (mmol/L)	Baseline, 9-month follow-up