Probiotics for Weight Loss

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Overweight

Intervention / Treatment
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* Dietary Supplement: LB001


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Four capsules containing rice flour will be given to the placebo group daily. | Dietary Supplement: LB001<br>* Probiotics<br>|
| Experimental: Single dose<br>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<br>* Probiotics<br>|
| Experimental: Double dose<br>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<br>* Probiotics<br>|

What is the study measuring?
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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 |