Digestive Symptoms, Elevated Liver Enzymes, Metabolic Health
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTPlant-Based Liquid 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.
Sponsors
Biocol Labs
Citruslabs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Age 40 to 60 years * Elevated ALT or AST identified during prescreening blood testing * Currently experiencing at least two of the following: Stomach discomfort, Constipation, Diarrhea, Heartburn, Bloating, Gas, Abdominal pain, Skin redness or pimples, Sugar cravings * Willing to comply with study requirements * Willing to discontinue supplements or herbal remedies targeting detoxification, digestive health, liver function, or skin health during the study * Willing to avoid starting new products, medications, or supplements targeting detoxification, digestive health, liver function, or skin health * Willing to maintain normal diet, sleep patterns, and activity levels * Generally healthy without uncontrolled chronic disease * Resides in the United States * Not participating in another research study during the study period * Has access to a study partner to take study photographs
Exclusion criteria
* Severe digestive disorders including acid reflux, IBS, IBD, Crohn's disease, or gastrointestinal tract surgeries * Liver disease * Known allergy or hypersensitivity to study product ingredients Chronic conditions that would interfere with study participation, including oncological or psychiatric disorders * Known severe allergic reactions * Pregnant, breastfeeding, or attempting to conceive * Unwilling to follow study procedures * Stopped hormonal birth control within the past month * History of substance abuse * Use of prescription diabetes medications, including GLP-1 receptor agonists such as Ozempic, Wegovy, or Mounjaro
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | Baseline, Day 30, Day 60, and Day 90. | Change in body weight measured using a Withings smart scale. |
| Change in Waist Circumference | Baseline, Day 7, Day 30, Day 60, and Day 90. | Change in waist circumference measured using a tape measure and recorded in centimeters. |
| Change in Body Fat Mass | Baseline, Day 7, Day 30, Day 60, and Day 90. | Change in body fat mass measured using a Withings smart scale. |
| Change in Lean Body Mass | Baseline, Day 7, Day 30, Day 60, and Day 90. | Change in lean body mass measured using a Withings smart scale. |
| Change in Visceral Fat Index | Baseline, Day 7, Day 30, Day 60, and Day 90. | Change in visceral fat index measured using a Withings smart scale. |
| Change in Alanine Aminotransferase (ALT) | Baseline, Day 30, Day 60, and Day 90. | Change in serum alanine aminotransferase concentration measured by hepatic function panel. |
| Change in Aspartate Aminotransferase (AST) | Baseline, Day 30, Day 60, and Day 90 | Change in serum aspartate aminotransferase concentration measured by hepatic function panel. |
| Change in Alkaline Phosphatase (ALP) | Baseline, Day 30, Day 60, and Day 90. | Change in serum alkaline phosphatase concentration measured by hepatic function panel. |
| Change in Total Bilirubin | Baseline, Day 30, Day 60, and Day 90. | Change in serum total bilirubin concentration measured by hepatic function panel. |
| Change in Total Cholesterol | Baseline, Day 30, Day 60, and Day 90. | Change in serum total cholesterol concentration measured by lipid panel. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Participant-Reported Bloating Severity | Baseline, Day 1, Day 3, Day 7, Day 30, Day 60, and Day 90. | Change in participant-reported bloating severity assessed by study questionnaire. |
| Change in Participant-Reported Flatulence Severity | Baseline, Day 1, Day 3, Day 7, Day 30, Day 60, and Day 90. | Change in participant-reported flatulence severity assessed by study questionnaire. |
| Change in Participant-Reported Heartburn Severity | Baseline, Day 1, Day 3, Day 7, Day 30, Day 60, and Day 90. | Change in participant-reported heartburn severity assessed by study questionnaire. |
| Change in Participant-Reported Digestive Comfort | Baseline, Day 1, Day 3, Day 7, Day 30, Day 60, and Day 90. | Change in participant-reported digestive comfort assessed by study questionnaire. |
| Change in Participant-Reported Skin Health | Baseline, Day 1, Day 3, Day 7, Day 30, Day 60, and Day 90. | Change in participant-reported skin health assessed by study questionnaire. |
Countries
United States
Outcome results
None listed