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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
81
Probiotics
Karolinska Institutet, Department of Clinical Science, Intervention and Technology
Huddinge, Stockholm County, Sweden
Weight change
Weight will be measured in kilograms using a scale.
Time frame: Baseline, 3-month follow-up
Weight change
Weight will be measured in kilograms using a scale.
Time frame: Baseline, 6-month follow-up
Waist circumference
Participants waist circumference will be measured using a standard tape measure (in cm).
Time frame: Baseline, 3-month follow-up
Waist circumference
Participants waist circumference will be measured using a standard tape measure (in cm).
Time frame: Baseline, 6-month follow-up
HbA1c
Glycated hemoglobin A1c will be measured in blood (mmol/mol)
Time frame: Baseline, 3-month follow-up
HbA1c
Glycated hemoglobin A1c will be measured in blood (mmol/mol)
Time frame: Baseline, 6-month follow-up
HDL
High-density lipoproteins will be measured in plasma (mmol/L)
Time frame: Baseline, 3-month follow-up
HDL
High-density lipoproteins will be measured in plasma (mmol/L)
Time frame: Baseline, 6-month follow-up
Triglycerides
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Triglycerides will be measured in plasma (mmol/L)
Time frame: Baseline, 3-month follow-up
Triglycerides
Triglycerides will be measured in plasma (mmol/L)
Time frame: Baseline, 9-month follow-up