Probiotics for Weight Loss

NCT04897698 | Completed

• 1 other identifier: 4-1326/2021
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight

Outcome Measures

Primary Outcomes (2)

• Weight change

  Weight will be measured in kilograms using a scale.

  Baseline, 3-month follow-up

• Weight change

  Weight will be measured in kilograms using a scale.

  Baseline, 6-month follow-up

Secondary Outcomes (8)

• Waist circumference

  Baseline, 3-month follow-up

• Waist circumference

  Baseline, 6-month follow-up

• HbA1c

  Baseline, 3-month follow-up

• HbA1c

  Baseline, 6-month follow-up

• HDL

  Baseline, 3-month follow-up

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Four capsules containing rice flour will be given to the placebo group daily.

Dietary Supplement: LB001

Single dose

EXPERIMENTAL

Two capsules of probiotics and two capsules of placebo daily. Probiotic capsules 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.

Dietary Supplement: LB001

Double dose

EXPERIMENTAL

Four capsules of probiotics daily. Probiotic capsules 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.

Dietary Supplement: LB001

Interventions

LB001 DIETARY_SUPPLEMENT

Probiotics

Double dose; Placebo; Single dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 26.0 - 29,99 kg/m2
• years old
• Willingness to lose weight

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• deFair Medical AB: collaborator

Study Sites (1)

Karolinska Institutet, Department of Clinical Science, Intervention and Technology

Huddinge, Stockholm County, 141 57, Sweden

Location

Related Publications (1)

• Danielsson P, Putri RR, Marcus C, Hagman E. Evaluating probiotic efficacy on weight loss in adults with overweight through a double-blind, placebo-controlled randomized trial. Sci Rep. 2023 Oct 24;13(1):18200. doi: 10.1038/s41598-023-45395-7.

  PMID: 37875559 DERIVED

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emilia Hagman, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 21, 2021
• Study Start: October 16, 2021
• Primary Completion: May 9, 2022
• Study Completion: May 9, 2022
• Last Updated: March 8, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)