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Completed

NCT Number: NCT05917314

A Study to Evaluate the Effect of SlimBiotics Probiotic Formula on Weight Management and Metabolic Health Outcomes

This study is to evaluate the efficacy of a probiotic supplement on weight management and metabolic health. This study will be conducted as a hybrid trial consisting of both in-person visits and virtual assessments. Two groups will be included: the intervention (SlimBiotics Probiotic) and placebo.

The SlimBiotics probiotic formula is the first plant-based probiotic targeting weight management and metabolic health. Other competing probiotics are isolated from humans (feces) but the strains in SlimBiotics were isolated from a fermented plant (millet porridge cereal).

This product contains 3 probiotic strains:

Limosilactobacillus fermentum K7-Lb1 Limosilactobacillus fermentum K8-Lb1 Limosilactobacillus fermentum K11-Lb3

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Key information

Conditions

Metabolic Health Behavior Body Weight Body Weight Changes Healthy Eating Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being Signs and Symptoms Sleep Stress Weight Loss Well-Being, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Women & Men
  • 18+
  • BMI between 25-32
  • Generally healthy - don't live with any uncontrolled chronic disease
  • Own a sleep-tracking device (smart watch etc.)

Exclusion criteria

  • Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
  • Anyone with known severe allergic reactions.
  • Women who are pregnant, breastfeeding or attempting to become pregnant
  • Unwilling to follow the study protocol.
  • Subjects currently enrolled in another clinical study
  • Subjects having finished another clinical study within the last 4 weeks before inclusion
  • Hypersensitivity, allergy or intolerance against any compound of the test products (e. g. acacia gum)
  • Condition after implantation of a cardiac pacemaker or other active implants
  • Sulfonylurea treatment
  • Any disease or condition which might compromise significantly the hepatic (ascites), hematopoietic, renal, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system with the exception of the conditions defined by the inclusion criteria
  • History of or present liver deficiency as defined by Quick < 70%
  • Regular medical treatment including over-the-counter, which may have an impact on the study aims (e.g. probiotics containing supplements, laxatives, steroids etc.)
  • History of hepatitis B, C, HIV
  • Subjects who are scheduled to undergo any diagnostic intervention or hospitalization which may cause protocol deviations
  • Simultaneous study participation by members of the same household
  • Pregnancy and lactation
  • Ascites as assessed by sonography
  • Any diet to lose body weight
  • Eating disorders or vegan diet
  • Anorexia drugs
  • Present drug abuse or alcoholism

Treatment and study plan

Slimbiotic Probiotic

Other

SlimBiotics Probiotic formula contains three probiotic strains of L. fermentum:

  • Limosilactobacillus fermentum K7-Lb1
  • Limosilactobacillus fermentum K8-Lb1
  • Limosilactobacillus fermentum K11-Lb3 The product also contains Microcrystalline cellulose.

Placebo

Other

The placebo capsule contains microcrystalline cellulose.

Primary outcomes

  1. Change in Visceral Fat Mass (VFM) [Time Frame: Baseline to Week 12]

    Time frame: 12 weeks

    VFM will be measured as an assessment of weight management.

  2. Change in Body Weight [Time Frame: Baseline to Week 12]

    Time frame: 12 weeks

    Body weight will be measured as an assessment of weight management.

  3. Change in Waist Circumference. [Time Frame: Baseline to Week 12]

    Time frame: 12 weeks

    Waist circumference will be measured as an assessment of weight management.

  4. Change in blood pressure. [Time Frame: Baseline to Week 12]

    Time frame: 12 weeks

    Blood pressure will be measured as a marker of metabolic health. Both both systolic and diastolic blood pressure will be measured.

  5. Change in resting heart rate. [Time Frame: Baseline to Week 12]

    Time frame: 12 weeks

    Resting heart rate will be measured as a marker of metabolic health.

  6. Changes in metabolic health symptoms. [Time Frame: Baseline to Week 12]

    Time frame: 12 weeks

    Survey based assessment (0-5 scale) of changes in metabolic health symptoms.

  7. Changes in total cholesterol [Time Frame: Baseline to Week 12]

    Time frame: 12 weeks

    Total cholesterol will be assessed as part of a lipid panel blood test.

  8. Changes in blood levels of triglycerides. [Time Frame: Baseline to Week 12]

    Time frame: 12 weeks

    Triglycerides will be assessed as part of a lipid panel blood test.

  9. Changes in blood levels of high-density lipoprotein. [Time Frame: Baseline to Week 12]

    Time frame: 12 weeks

    Blood levels of high-density lipoprotein will be assessed as part of a lipid panel blood test.

  10. Changes in blood levels of low-density lipoprotein. [Time Frame: Baseline to Week 12]

    Time frame: 12 weeks

    Blood levels of low-density lipoprotein will be assessed as part of a lipid panel blood test.

  11. Changes in blood glucose. [Time Frame: Baseline to Week 12]

    Time frame: 12 weeks

    Blood glucose levels will be assessed via blood test.

  12. Changes in blood insulin levels. [Time Frame: Baseline to Week 12]

    Time frame: 12 weeks

    Blood insulin levels will be assessed via blood test.

  13. Changes in hbA1c. [Time Frame: Baseline to Week 12]

    Time frame: 12 weeks

    hbA1c will be assessed via blood test.

  14. Changes in hs-high-sensitivity C-reactive protein (hsCRP). [Time Frame: Baseline to Week 12]

    Time frame: 12 weeks

    hsCRP will be assessed via blood test.

  15. Changes in alanine transaminase. [Time Frame: Baseline to Week 12]

    Time frame: 12 weeks

    Alanine transaminase will be assessed via blood test.

  16. Changes in aspartate aminotransferase. [Time Frame: Baseline to Week 12]

    Time frame: 12 weeks

    Aspartate aminotransferase will be assessed via blood test.

  17. Changes in gamma-glutamyl transferase (GGT). [Time Frame: Baseline to Week 12]

    Time frame: 12 weeks

    GGT will be assessed via blood test.

Secondary outcomes

  1. Changes in sleep duration. [Time Frame: Baseline to Week 12]

    Time frame: 12 weeks

    Changes in sleep duration will be assessed by the participants using their own smart device (e.g. sleep tracker, Apple Watch, FitBit etc)

  2. Changes in participants-perceived sleep quality. [Time Frame: Baseline to Week 12]

    Time frame: 12 weeks

    Changes in sleep quality will be assessed using study-specific surveys (0-5 scale).

  3. Changes in participant-reported mental wellbeing. [Time Frame: Baseline to Week 12]

    Time frame: 12 weeks

    Mental well-being will be assessed study-specific surveys (0-5 scale).

  4. Changes in scores on the Anxiety GAD7 Questionnaire [Time Frame: Baseline to Week 12]

    Time frame: 12 weeks

    Anxiety will be assessed using the validated Anxiety GAD7 Questionnaire (0-4 scale).

  5. Changes in health eating habits. [Time Frame: Baseline to Week 12]

    Time frame: 12 weeks

    Changes in healthy eating habits and satiety will be assessed using the standardised Three-Factor Eating Questionnaire (0-4 scale).

Sponsors and collaborators

Lead sponsor

Slimbiotics

Unknown

Collaborators

  • Citruslabs

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of SlimBiotics Probiotic Formula on Weight Management and Metabolic Health Outcomes

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 23, 2023
Registry last updated
Aug 23, 2024

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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