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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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This single-arm clinical trial will evaluate the effects of a plant-based liquid supplement on metabolic health, digestive health, skin health, and overall well-being. Twenty participants aged 40 to 60 years with elevated alanine transaminase (ALT) or aspartate transaminase (AST) levels will use the supplement daily for 90 days. Participants will complete questionnaires, provide body composition and waist circumference measurements, submit photographs, and undergo blood testing throughout the study. Outcomes include changes in metabolic biomarkers, body composition, digestive symptoms, skin health, and overall well-being.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plant-Based Liquid Supplement | Experimental | Participants will consume one ampule of the study product diluted in approximately 8 ounces of water before the first meal of the day throughout the study period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plant-Based Liquid Supplement | Dietary Supplement | A liquid dietary supplement containing choline bitartrate, zinc sulfate, manganese sulfate, artichoke leaf extract, fennel extract, rosemary leaf extract, L-arginine monohydrochloride, inositol, bromelain, papain, sorbitol, glycerin, artificial flavour, and potassium sorbate. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Change in body weight measured using a Withings smart scale. | Baseline, Day 30, Day 60, and Day 90. |
| Change in Waist Circumference | Change in waist circumference measured using a tape measure and recorded in centimeters. | Baseline, Day 7, Day 30, Day 60, and Day 90. |
| Change in Body Fat Mass | Change in body fat mass measured using a Withings smart scale. | Baseline, Day 7, Day 30, Day 60, and Day 90. |
| Change in Lean Body Mass | Change in lean body mass measured using a Withings smart scale. | Baseline, Day 7, Day 30, Day 60, and Day 90. |
| Change in Visceral Fat Index | Change in visceral fat index measured using a Withings smart scale. | Baseline, Day 7, Day 30, Day 60, and Day 90. |
| Change in Alanine Aminotransferase (ALT) | Change in serum alanine aminotransferase concentration measured by hepatic function panel. | Baseline, Day 30, Day 60, and Day 90. |
| Change in Aspartate Aminotransferase (AST) | Change in serum aspartate aminotransferase concentration measured by hepatic function panel. | Baseline, Day 30, Day 60, and Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Participant-Reported Bloating Severity | Change in participant-reported bloating severity assessed by study questionnaire. | Baseline, Day 1, Day 3, Day 7, Day 30, Day 60, and Day 90. |
| Change in Participant-Reported Flatulence Severity |
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Inclusion Criteria:
Stomach discomfort, Constipation, Diarrhea, Heartburn, Bloating, Gas, Abdominal pain, Skin redness or pimples, Sugar cravings
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Las Vegas | Nevada | 89118 | United States |
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| Change in Alkaline Phosphatase (ALP) |
Change in serum alkaline phosphatase concentration measured by hepatic function panel. |
| Baseline, Day 30, Day 60, and Day 90. |
| Change in Total Bilirubin | Change in serum total bilirubin concentration measured by hepatic function panel. | Baseline, Day 30, Day 60, and Day 90. |
| Change in Total Cholesterol | Change in serum total cholesterol concentration measured by lipid panel. | Baseline, Day 30, Day 60, and Day 90. |
Change in participant-reported flatulence severity assessed by study questionnaire.
| Baseline, Day 1, Day 3, Day 7, Day 30, Day 60, and Day 90. |
| Change in Participant-Reported Heartburn Severity | Change in participant-reported heartburn severity assessed by study questionnaire. | Baseline, Day 1, Day 3, Day 7, Day 30, Day 60, and Day 90. |
| Change in Participant-Reported Digestive Comfort | Change in participant-reported digestive comfort assessed by study questionnaire. | Baseline, Day 1, Day 3, Day 7, Day 30, Day 60, and Day 90. |
| Change in Participant-Reported Skin Health | Change in participant-reported skin health assessed by study questionnaire. | Baseline, Day 1, Day 3, Day 7, Day 30, Day 60, and Day 90. |