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The goal of this crossover clinical trial is to evaluate the efficacy and safety of Bloat Gummies on postprandial bloating and related gastrointestinal discomfort in healthy adults with recurrent bloating. The main question it aims to answer is whether Bloat gummies reduce post-meal bloating, gas, or abdominal pain (stomach) discomfort. Participants will be asked to consume one dose of Bloat or Placebo after 2 test meals and answer questionnaires on gas, bloating and abdominal distension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bloat Gummy | Experimental | Bloat is a gummy that contains the active ingredients ginger root extract, lemon balm extract, dandelion root extract and the postbiotic HTES1, Bifidobacterium longum CECT7347. |
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| Placebo Gummy | Placebo Comparator | The placebo is a gummy that looks and tastes like the study gummy, but with no active ingredients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bloat Gummies | Dietary Supplement | Participants will be instructed to take one dose (2 gummies) 30 minutes after consumption of the entire standardized meal during 2 test meal sessions, at least 7 days apart. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in bloating severity from pre-dose to t = 60 minutes post-dose as, comparing active product vs. placebo. | Bloating severity assessed by Bloating Likert Scale of 0 to 4, with 0 being "no symptoms" and 4 being "severe symptoms." | Evaluated from pre-dose to 60 minutes post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in bloating severity from pre-dose to t = 30 minutes post-dose, comparing active product vs placebo. | Bloating severity assessed by Bloating Likert Scale of 0 to 4, with 0 being "no symptoms" and 4 being "severe symptoms." | Evaluated from pre-dose to 30 minutes post-dose |
| Mean change in gas severity from pre-dose to t = 30 and 60 minutes post-dose, comparing active product vs. placebo. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alethios, Inc. | San Francisco | California | 94109 | United States |
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| ID | Term |
|---|---|
| D009085 | Mucopolysaccharidosis IV |
| ID | Term |
|---|---|
| D009083 | Mucopolysaccharidoses |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
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| Placebo | Dietary Supplement | Participants will be instructed to take one dose (2 gummies) 30 minutes after consumption of the entire standardized meal during 2 test meal sessions, at least 7 days apart. |
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Gas severity will be assessed by a Gas Likert scale of 0 to 4, with 0 being "no symptoms" and 4 being "severe symptoms." |
| Evaluated from pre-dose to 30 and 60 minutes post-dose. |
| Mean change in abdominal discomfort severity from pre-dose to t = 30 and 60 minutes post-dose, comparing active product vs. placebo. | Abdominal discomfort assessed by abdominal discomfort Likert Scale, of 0 to 4, with 0 being "no symptoms" and 4 being "severe symptoms." | Evaluated from pre-dose to 30 and 60 minutes post-dose. |
| Mean change in waist circumference from pre-dose to t = 30 and t = 60 minutes post-dose, comparing active product vs. placebo. | Abdominal distension assessed by mean change in waist circumference measurement. | Evaluated from pre-dose to 30 and 60 minutes post-dose. |
| Proportion of participants demonstrating a reduction in waist circumference. | Abdominal distension assessed by mean change in waist circumference measurement. | Evaluated at 30 minutes, 60 minutes or both timepoints post-dose. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D016464 | Lysosomal Storage Diseases |
| D017520 | Mucinoses |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |