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Completed

NCT Number: NCT04897698

Probiotics for Weight Loss

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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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet, Department of Clinical Science, Intervention and Technology

Huddinge, Stockholm County, 141 57, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LB001

Dietary Supplement

Probiotics

Primary outcomes

  1. Weight change

    Time frame: Baseline, 3-month follow-up

    Weight will be measured in kilograms using a scale.

  2. Weight change

    Time frame: Baseline, 6-month follow-up

    Weight will be measured in kilograms using a scale.

Secondary outcomes

  1. Waist circumference

    Time frame: Baseline, 3-month follow-up

    Participants waist circumference will be measured using a standard tape measure (in cm).

  2. Waist circumference

    Time frame: Baseline, 6-month follow-up

    Participants waist circumference will be measured using a standard tape measure (in cm).

  3. HbA1c

    Time frame: Baseline, 3-month follow-up

    Glycated hemoglobin A1c will be measured in blood (mmol/mol)

  4. HbA1c

    Time frame: Baseline, 6-month follow-up

    Glycated hemoglobin A1c will be measured in blood (mmol/mol)

  5. HDL

    Time frame: Baseline, 3-month follow-up

    High-density lipoproteins will be measured in plasma (mmol/L)

  6. HDL

    Time frame: Baseline, 6-month follow-up

    High-density lipoproteins will be measured in plasma (mmol/L)

  7. Triglycerides

    Time frame: Baseline, 3-month follow-up

    Triglycerides will be measured in plasma (mmol/L)

  8. Triglycerides

    Time frame: Baseline, 9-month follow-up

    Triglycerides will be measured in plasma (mmol/L)

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • deFair Medical AB

Registry information

Official study title

LB001 Study: Probiotics for Weight Loss: A Randomized Controlled Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 21, 2021
Registry last updated
Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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