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A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on GI health and related health outcomes
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.
Eligible participants will (1) endorse a desire for improved bowel habits, less bloating/indigestion, and/or fewer stomach aches/pains (2) have the opportunity for meaningful improvement (at least 20%) in their primary health outcome, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.
Self-reported data are collected electronically from eligible participants for 7 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Control 1.1 | Placebo Comparator | GI Health Product Form 1 - control |
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| Active Product 1.1 | Experimental | GI Health Product Form 1 - active product 1 |
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| Placebo Control 2 | Placebo Comparator | GI Health Product Form 2 - control |
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| Active Product 2.1 | Experimental | GI Health Product Form 2 - active product 1 |
|
| Placebo Control 3 | Placebo Comparator | GI Health Product Form 3 - control |
|
| Active Product 3.1 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radicle GI Health Placebo Control Form 1 | Dietary Supplement | Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in GI (Gastrointestinal) Health (1) | Mean difference in Gastrointestinal Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Belly Pain 5A (scale 2-25; with higher scores corresponding to more severe abdominal pain) | 6 weeks |
| Change in GI (Gastrointestinal) Health (2) | Mean difference in Gastrointestinal Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Gas and Bloating 13A (scale 2-60; with higher scores corresponding to more severe gas/bloating) | 6 weeks |
| Change in GI (Gastrointestinal) Health (3) | Mean difference in GI Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Constipation 9A (scale 5-45; with higher scores corresponding to more severe constipation) | 6 weeks |
| Change in GI (Gastrointestinal) Health (4) | Mean difference in GI Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Diarrhea 6A (scale 2-30; with higher scores corresponding to more severe diarrhea) | 6 weeks |
| Change in GI (Gastrointestinal) Health (5) | Mean difference in GI Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Gastroesophageal Reflux 13A (scale 8-64; with higher scores corresponding to more severe reflux) | 6 weeks |
| Change in GI (Gastrointestinal) Health (6) | Mean difference in GI Health scores as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Nausea and Vomiting 4A (scale 3-20; with higher scores corresponding to more severe nausea and vomiting) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in feelings of anxiety | Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety) | 6 weeks |
| Change in GI-related Quality of Life (QOL) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in concentration of at-home (direct-to-consumer) specimen assays either saliva, blood or stool | Mean difference in specimen assays as surrogates and/or markers for health outcomes. (Optional; among consented participants only) Potentially include saliva (IgG, cytokines, DHEA-S, Estradiol, Progesterone, Testosterone, Cortisol, Melatonin, CRP) blood (1 drop) (Cortisol, Homocysteine, Ferritin, TSH, HbA1c, Insulin, Vitamin D, DHEA-S, Testosterone, Estradiol, FSH, Total Cholesterol, HDL, LDL, Triglycerides, ApoA1, ApoB). Stool (microbial diversity). Test are optional. Unit of measure will vary based on test selected |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily K. Pauli, PharmD | Radicle Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radicle Science, Inc | Del Mar | California | 92014 | United States |
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| Label | URL |
|---|---|
| Radicle Science, Inc | View source |
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Data will not be shared with researchers outside of Radicle Collaborators on this study.
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Participants will be stratified based on gender at birth then randomized to one of the study arms
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The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
GI Health Product Form 3 - active product 1
|
| Placebo Control 4 | Placebo Comparator | GI Health Product Form 4 - control |
|
| Active Product 4.1 | Experimental | GI Health Product Form 4 - active product 1 |
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| Placebo Control 5 | Placebo Comparator | GI Health Product Form 5 - control |
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| Active Product 5.1 | Experimental | GI Health Product Form 5 - active product 1 |
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| Placebo Control 7.1.0 | Placebo Comparator | GI Health Product Form 7.1- control |
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| Active Product 7.1.1 | Experimental | GI Health Product Form 7.1 - active product 1 |
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| Placebo Control 7.2.0 | Placebo Comparator | GI Health Product Form 7.2 - control |
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| Active Product 7.2.1 | Experimental | GI Health Product Form 7.2 - active product 1 |
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| Placebo Control 7.3.0 | Placebo Comparator | GI Health Product Form 7.3 - control |
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| Active Product 7.3.1 | Experimental | GI Health Product Form 7.3 - active product 1 |
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| Placebo Control 7.4.0 | Placebo Comparator | GI Health Product Form 7.4 - control |
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| Active Product 7.4.1 | Experimental | GI Health Product Form 7.4 - active product 1 |
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| Radicle GI Health Active Study Product 1.1 Usage | Dietary Supplement | Participants will use their Radicle GI Health Active Study Product 1.1 as directed for a period of 6 weeks. |
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| Radicle GI Health Placebo Control Form 2 | Dietary Supplement | Participants will use their Placebo Control Form 2 as directed for a period of 6 weeks. |
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| Radicle GI Health Active Study Product 2.1 Usage | Dietary Supplement | Participants will use their Radicle GI Health Active Study Product 2.1 as directed for a period of 6 weeks. |
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| Radicle GI Health Placebo Control Form 3 | Dietary Supplement | Participants will use their Placebo Control Form 3 as directed for a period of 6 weeks. |
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| Radicle GI Health Active Study Product 3.1 Usage | Dietary Supplement | Participants will use their Radicle GI Health Active Study Product 3.1 as directed for a period of 6 weeks. |
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| Radicle GI Health Placebo Control Form 4 | Dietary Supplement | Participants will use their Placebo Control Form 4 as directed for a period of 6 weeks. |
|
| Radicle GI Health Active Study Product 4.1 Usage | Dietary Supplement | Participants will use their Radicle GI Health Active Study Product 4.1 as directed for a period of 6 weeks. |
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| Radicle GI Health Placebo Control Form 5 | Dietary Supplement | Participants will use their Placebo Control Form 5 as directed for a period of 6 weeks. |
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| Radicle GI Health Active Study Product 5.1 Usage | Dietary Supplement | Participants will use their Radicle GI Health Active Study Product 5.1 as directed for a period of 6 weeks. |
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| Radicle GI Health Placebo Control Form 7 | Dietary Supplement | Participants will use their Placebo Control Form 7 as directed for a period of 6 weeks. |
|
| Radicle GI Health Active Study Product 7.1 Usage | Dietary Supplement | Participants will use their Radicle GI Health Active Study Product 7.1 as directed for a period of 6 weeks. |
|
| Radicle GI Health Placebo Control 7.2 | Dietary Supplement | Participants will use their Placebo Control 7.2 as directed for a period of 6 weeks. |
|
| Radicle GI Health Active Study Product 7.2.1 Usage | Dietary Supplement | Participants will use their Radicle GI Health Active Study Product 7.2.1 as directed for a period of 6 weeks. |
|
| Radicle GI Health Placebo Control 7.3.0 | Dietary Supplement | Participants will use their Placebo Control 7.3 as directed for a period of 6 weeks. |
|
| Radicle GI Health Active Study Product 7.3.1 Usage | Dietary Supplement | Participants will use their Radicle GI Health Active Study Product 7.3.1 as directed for a period of 6 weeks. |
|
| Radicle GI Health Placebo Control 7.4.0 | Dietary Supplement | Participants will use their Placebo Control 7.4 as directed for a period of 6 weeks. |
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| Radicle GI Health Active Study Product 7.4.1 Usage | Dietary Supplement | Participants will use their Radicle GI Health Active Study Product 7.4.1 as directed for a period of 6 weeks. |
|
| 6 weeks |
Mean difference in GI-related QOL as assessed by Digestion-associated QOL Questionnaire (DGLQ) (scale 0%-100%; with higher scores corresponding to worse GI-related QOL)
| 6 weeks |
| Change in mood (emotional distress-depression) | Mean difference in emotional distress score as assessed by PROMIS Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress) | 6 weeks |
| Minimal clinically important difference (MCID) in GI Health (1) | Likelihood of experiencing minimal clinically important difference in GI Health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Belly Pain 5A (scale 2-25; with higher scores corresponding to more severe abdominal pain) | 6 weeks |
| Minimal clinically important difference (MCID) in GI Health (2) | Likelihood of experiencing minimal clinically important difference in GI Health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Gas and Bloating 13A (scale 2-60; with higher scores corresponding to more severe gas/bloating) | 6 weeks |
| Minimal clinically important difference (MCID) in GI Health (3) | Likelihood of experiencing minimal clinically important difference in GI Health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Constipation 9A (scale 5-45; with higher scores corresponding to more severe constipation) | 6 weeks |
| Minimal clinically important difference (MCID) in GI Health (4) | Likelihood of experiencing minimal clinically important difference in GI Health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Diarrhea 6A (scale 2-30; with higher scores corresponding to more severe diarrhea) | 6 weeks |
| Minimal clinically important difference (MCID) in GI Health (5) | Likelihood of experiencing minimal clinically important difference in GI Health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Gastroesophageal Reflux 13A (scale 8-64; with higher scores corresponding to more severe reflux) | 6 weeks |
| Minimal clinically important difference (MCID) in GI Health (6) | Likelihood of experiencing minimal clinically important difference in GI Health score as assessed by Patient Reported Outcome Measurement System (PROMIS) Gastrointestinal Nausea and Vomiting 4A (scale 3-20; with higher scores corresponding to more severe nausea and vomiting) | 6 weeks |
| Minimal clinically important difference (MCID) in feelings of anxiety | Likelihood of experiencing minimal clinically important difference in feelings of anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety) | 6 weeks |
| Minimal clinically important difference (MCID) in GI-related QOL | Likelihood of experiencing minimal clinically important difference in GI-related QOL score as assessed by Digestion-associated QOL Questionnaire (DGLQ) (scale 0%-100%; with higher scores corresponding to worse GI-related QOL) | 6 weeks |
| Minimal clinically important difference (MCID) in mood (emotional distress-depression) | Likelihood of experiencing minimal clinically important difference in mood score as assessed by PROMIS Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress) | 6 weeks |
| 6 weeks |
| ID | Term |
|---|---|
| D015746 | Abdominal Pain |
| D004066 | Digestive System Diseases |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
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