Overweight
Conditions
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTLB001
Probiotics
Sponsors
deFair Medical AB
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight change | Baseline, 3-month follow-up | Weight will be measured in kilograms using a scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Waist circumference | Baseline, 3-month follow-up | Participants waist circumference will be measured using a standard tape measure (in cm). |
| HbA1c | Baseline, 3-month follow-up | Glycated hemoglobin A1c will be measured in blood (mmol/mol) |
| HDL | Baseline, 3-month follow-up | High-density lipoproteins will be measured in plasma (mmol/L) |
| Triglycerides | Baseline, 3-month follow-up | Triglycerides will be measured in plasma (mmol/L) |
Countries
Sweden
Outcome results
None listed