Clinical trial NCT04897698: Probiotics for Weight Loss
Official title: LB001 Study: Probiotics for Weight Loss: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: deFair Medical AB
First posted: 2021-05-21
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight change
timeFrame: Baseline, 3-month follow-up
measure: Weight change
timeFrame: Baseline, 6-month follow-up
Secondary outcomes:
measure: Waist circumference
timeFrame: Baseline, 3-month follow-up
measure: Waist circumference
timeFrame: Baseline, 6-month follow-up
measure: HbA1c
timeFrame: Baseline, 3-month follow-up
measure: HbA1c
timeFrame: Baseline, 6-month follow-up
measure: HDL
timeFrame: Baseline, 3-month follow-up
measure: HDL
timeFrame: Baseline, 6-month follow-up
measure: Triglycerides
timeFrame: Baseline, 3-month follow-up
measure: Triglycerides
timeFrame: Baseline, 9-month follow-up
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Karolinska Institutet, Department of Clinical Science, Intervention and Technology
state: Stockholm
Study officials:
affiliation: Karolinska Institutet
name: Emilia Hagman, PhD
role: PRINCIPAL_INVESTIGATOR
References: