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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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This study is to evaluate the efficacy of a postbiotic 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 postbiotic) and placebo.
The SlimBiotics postbiotic formula is the first plant-based postbiotic targeting weight management and metabolic health. Other competing postbiotics are isolated from humans (feces) but the strains in SlimBiotics were isolated from a fermented plant (millet porridge cereal)
This product contains L. fermentum K8 Postbiotic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group (SlimBiotic Postbiotic) | Experimental | Participants will take 1 serving (1 capsule) per day. |
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| Placebo Group | Placebo Comparator | Participants will take 1 serving (1 capsule) per day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Slimbiotics Postbiotic | Other | SlimBiotics postbiotic formula contains the following ingredients:
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Visceral Fat Mass (VFM) [Time Frame: Baseline to Week 12] | VFM will be measured as an assessment of weight management. | 12 weeks |
| Change in Body Weight [Time Frame: Baseline to Week 12] | Body weight will be measured as an assessment of weight management. | 12 weeks |
| Change in Waist Circumference. [Time Frame: Baseline to Week 12] | Waist circumference will be measured as an assessment of weight management. | 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. | 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. | 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. | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in sleep duration. [Time Frame: Baseline to Week 12] | Changes in sleep will be assessed by the participants using their own smart device (e.g. sleep tracker, Apple Watch, FitBit etc) | 12 weeks |
| Changes in participants-perceived sleep quality. [Time Frame: Baseline to Week 12] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick Renner, MSc | Contact | 4242450285 | hello@citruslabs.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Santa Monica | California | 90404 | United States |
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Randomized Controlled Trial. Participants will be randomized into the intervention group (SlimBiotics Postbiotic) or into a placebo product control group
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Both participant groups and the study coordinators will be blinded to the allocation.
| Placebo | Other | The placebo capsules contain microcrystalline cellulose only. |
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| Changes in blood levels of triglycerides. [Time Frame: Baseline to Week 12] |
Triglycerides will be assessed as part of a lipid panel blood test. |
| 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. | 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. | 12 weeks |
| Changes in blood glucose. [Time Frame: Baseline to Week 12] | Blood glucose levels will be assessed via blood test. | 12 weeks |
| Changes in blood insulin levels. [Time Frame: Baseline to Week 12] | Blood insulin levels will be assessed via blood test. | 12 weeks |
| Changes in hbA1c. [Time Frame: Baseline to Week 12] | hbA1c will be assessed via blood test. | 12 weeks |
| Changes in hs-high-sensitivity C-reactive protein (hsCRP). [Time Frame: Baseline to Week 12] | hsCRP will be assessed via blood test. | 12 weeks |
| Changes in alanine transaminase. [Time Frame: Baseline to Week 12] | Alanine transaminase will be assessed via blood test. | 12 weeks |
| Changes in aspartate aminotransferase. [Time Frame: Baseline to Week 12] | Aspartate aminotransferase will be assessed via blood test. | 12 weeks |
| Changes in gamma-glutamyl transferase (GGT). [Time Frame: Baseline to Week 12] | GGT will be assessed via blood test. | 12 weeks |
Changes in sleep quality will be assessed using study-specific surveys (0-5 scale). |
| 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). | 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). | 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). | 12 weeks |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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