Overweight Clinical Trial
Official title:
LB001 Study: Probiotics for Weight Loss: A Randomized Controlled Study
Verified date | March 2023 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska Institutet, Department of Clinical Science, Intervention and Technology | Huddinge | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | deFair Medical AB |
Sweden,
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 |
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