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| Name | Class |
|---|---|
| deFair Medical AB | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Four capsules containing rice flour will be given to the placebo group daily. |
|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LB001 | Dietary Supplement | Probiotics |
|
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emilia Hagman, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet, Department of Clinical Science, Intervention and Technology | Huddinge | Stockholm County | 141 57 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37875559 | Derived | 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. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |