Karolinska Institutet, Department of Clinical Science, Intervention and Technology
Huddinge, Stockholm County, 141 57, Sweden
NCT Number: NCT04897698
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.
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Notify Me18 year–45 year
All sexes
Interventional
Not applicable
Huddinge, Stockholm County, 141 57, Sweden
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Probiotics
Time frame: Baseline, 3-month follow-up
Weight will be measured in kilograms using a scale.
Time frame: Baseline, 6-month follow-up
Weight will be measured in kilograms using a scale.
Time frame: Baseline, 3-month follow-up
Participants waist circumference will be measured using a standard tape measure (in cm).
Time frame: Baseline, 6-month follow-up
Participants waist circumference will be measured using a standard tape measure (in cm).
Time frame: Baseline, 3-month follow-up
Glycated hemoglobin A1c will be measured in blood (mmol/mol)
Time frame: Baseline, 6-month follow-up
Glycated hemoglobin A1c will be measured in blood (mmol/mol)
Time frame: Baseline, 3-month follow-up
High-density lipoproteins will be measured in plasma (mmol/L)
Time frame: Baseline, 6-month follow-up
High-density lipoproteins will be measured in plasma (mmol/L)
Time frame: Baseline, 3-month follow-up
Triglycerides will be measured in plasma (mmol/L)
Time frame: Baseline, 9-month follow-up
Triglycerides will be measured in plasma (mmol/L)
Karolinska Institutet
Other
LB001 Study: Probiotics for Weight Loss: A Randomized Controlled Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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