Metabolic HealthNCT05917314
A Study to Evaluate the Effect of SlimBiotics Probiotic Formula on Weight Management and Metabolic Health Outcomes
A study testing Slimbiotic Probiotic in people with Metabolic Health and Weight Loss, run by Slimbiotics at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Health, Weight Loss, Stress
- What is being tested?
- Slimbiotic Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled 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).
Read more
This product contains 3 probiotic strains:
Limosilactobacillus fermentum K7-Lb1 Limosilactobacillus fermentum K8-Lb1 Limosilactobacillus fermentum K11-Lb3
- Conditions
- Metabolic Health, Weight Loss, Stress, Well-Being, Psychological, Sleep, Healthy Eating
- Being tested
- Slimbiotic Probiotic, Placebo
- Medical subject headings
- Weight Loss, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slimbiotic ProbioticOther
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.
PlaceboOther
The placebo capsule contains microcrystalline cellulose.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (SlimBiotic Probiotic) | Experimental | Participants will take 1 serving (1 capsule) per day. Receives: Other: Slimbiotic Probiotic |
| Placebo Group | Placebo comparator | Participants will take 1 serving (1 capsule) per day. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visceral Fat Mass (VFM) [Time Frame: Baseline to Week 12]
VFM will be measured as an assessment of weight management.
Measured: 12 weeks
Change in Body Weight [Time Frame: Baseline to Week 12]
Body weight will be measured as an assessment of weight management.
Measured: 12 weeks
Change in Waist Circumference. [Time Frame: Baseline to Week 12]
Waist circumference will be measured as an assessment of weight management.
Measured: 12 weeks
Change in blood pressure. [Time Frame: Baseline to Week 12]
Blood pressure will be measured as a marker of metabolic health. Both both systolic and diastolic blood pressure will be measured.
Measured: 12 weeks
Change in resting heart rate. [Time Frame: Baseline to Week 12]
Resting heart rate will be measured as a marker of metabolic health.
Measured: 12 weeks
Changes in metabolic health symptoms. [Time Frame: Baseline to Week 12]
Survey based assessment (0-5 scale) of changes in metabolic health symptoms.
Measured: 12 weeks
Changes in total cholesterol [Time Frame: Baseline to Week 12]
Total cholesterol will be assessed as part of a lipid panel blood test.
Measured: 12 weeks
Changes in blood levels of triglycerides. [Time Frame: Baseline to Week 12]
Triglycerides will be assessed as part of a lipid panel blood test.
Measured: 12 weeks
Changes in blood levels of high-density lipoprotein. [Time Frame: Baseline to Week 12]
Blood levels of high-density lipoprotein will be assessed as part of a lipid panel blood test.
Measured: 12 weeks
Changes in blood levels of low-density lipoprotein. [Time Frame: Baseline to Week 12]
Blood levels of low-density lipoprotein will be assessed as part of a lipid panel blood test.
Measured: 12 weeks
Changes in blood glucose. [Time Frame: Baseline to Week 12]
Blood glucose levels will be assessed via blood test.
Measured: 12 weeks
Changes in blood insulin levels. [Time Frame: Baseline to Week 12]
Blood insulin levels will be assessed via blood test.
Measured: 12 weeks
Changes in hbA1c. [Time Frame: Baseline to Week 12]
hbA1c will be assessed via blood test.
Measured: 12 weeks
Changes in hs-high-sensitivity C-reactive protein (hsCRP). [Time Frame: Baseline to Week 12]
hsCRP will be assessed via blood test.
Measured: 12 weeks
Changes in alanine transaminase. [Time Frame: Baseline to Week 12]
Alanine transaminase will be assessed via blood test.
Measured: 12 weeks
Changes in aspartate aminotransferase. [Time Frame: Baseline to Week 12]
Aspartate aminotransferase will be assessed via blood test.
Measured: 12 weeks
Changes in gamma-glutamyl transferase (GGT). [Time Frame: Baseline to Week 12]
GGT will be assessed via blood test.
Measured: 12 weeks
Secondary outcomes (5)
Changes in sleep duration. [Time Frame: Baseline to Week 12]
Changes in sleep duration will be assessed by the participants using their own smart device (e.g. sleep tracker, Apple Watch, FitBit etc)
Measured: 12 weeks
Changes in participants-perceived sleep quality. [Time Frame: Baseline to Week 12]
Changes in sleep quality will be assessed using study-specific surveys (0-5 scale).
Measured: 12 weeks
Changes in participant-reported mental wellbeing. [Time Frame: Baseline to Week 12]
Mental well-being will be assessed study-specific surveys (0-5 scale).
Measured: 12 weeks
Changes in scores on the Anxiety GAD7 Questionnaire [Time Frame: Baseline to Week 12]
Anxiety will be assessed using the validated Anxiety GAD7 Questionnaire (0-4 scale).
Measured: 12 weeks
Changes in health eating habits. [Time Frame: Baseline to Week 12]
Changes in healthy eating habits and satiety will be assessed using the standardised Three-Factor Eating Questionnaire (0-4 scale).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Jul 2023
- Primary completion24 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial. Participants will be randomized into the intervention group (SlimBiotics Probiotic) or into a placebo product control group.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Slimbiotics
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917314
- Sponsor's protocol ID
- 20317
- Status last verified
- Aug 2024
- First submitted
- 1 Jun 2023
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of SlimBiotics Probiotic Formula on Weight Management and Metabolic Health Outcomes
- ClinicalTrials.gov ID
- NCT05917314
- Acronym / sponsor ID
- 20317
- Conditions
- Metabolic Health, Weight Loss, Stress, Well-Being, Psychological, Sleep, Healthy Eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Slimbiotics
- Collaborators
- Citruslabs
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 24 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial. Participants will be randomized into the intervention group (SlimBiotics Probiotic) or into a placebo product control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (SlimBiotic Probiotic) | Experimental | Other: Slimbiotic ProbioticParticipants will take 1 serving (1 capsule) per day. |
| Placebo Group | Placebo comparator | Other: PlaceboParticipants will take 1 serving (1 capsule) per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.)
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Slimbiotic ProbioticSlimBiotics 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. | Other | Intervention Group (SlimBiotic Probiotic) |
| PlaceboThe placebo capsule contains microcrystalline cellulose. | Other | Placebo Group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Changes in blood glucose. [Time Frame: Baseline to Week 12]
Time frame: 12 weeks
Blood glucose levels will be assessed via blood test.
Changes in blood insulin levels. [Time Frame: Baseline to Week 12]
Time frame: 12 weeks
Blood insulin levels will be assessed via blood test.
Changes in hbA1c. [Time Frame: Baseline to Week 12]
Time frame: 12 weeks
hbA1c will be assessed via blood test.
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.
Changes in alanine transaminase. [Time Frame: Baseline to Week 12]
Time frame: 12 weeks
Alanine transaminase will be assessed via blood test.
Changes in aspartate aminotransferase. [Time Frame: Baseline to Week 12]
Time frame: 12 weeks
Aspartate aminotransferase will be assessed via blood test.
Changes in gamma-glutamyl transferase (GGT). [Time Frame: Baseline to Week 12]
Time frame: 12 weeks
GGT will be assessed via blood test.
5 secondary outcomes
Changes in sleep duration. [Time Frame: Baseline to Week 12]
Time frame: 12 weeks
Changes in participants-perceived sleep quality. [Time Frame: Baseline to Week 12]
Time frame: 12 weeks
Changes in participant-reported mental wellbeing. [Time Frame: Baseline to Week 12]
Time frame: 12 weeks
Changes in scores on the Anxiety GAD7 Questionnaire [Time Frame: Baseline to Week 12]
Time frame: 12 weeks
Changes in health eating habits. [Time Frame: Baseline to Week 12]
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Metabolic Health
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Recruiting
Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments
Obesity
Enrolling by invitationObservational study
Long-term Impacts of Psychosocial Stimulation and Iron Supplementation
Iron Deficiency Anemia, Parenting Intervention
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Not yet recruiting
A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slimbiotic Probiotic in people with Metabolic Health and Weight Loss, run by Slimbiotics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visceral Fat Mass (VFM) [Time Frame: Baseline to Week 12] (time frame: 12 weeks). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.