A Clinical Trial to Evaluate the Effects of a Plant-Based Liquid Supplement on Metabolic Health and Overall Well-Being
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nevada
-
Las Vegas, Nevada, United States, 89118
- Citruslabs
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Plant-Based Liquid Supplement
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Body Weight
Time Frame: Baseline, Day 30, Day 60, and Day 90.
|
Change in body weight measured using a Withings smart scale.
|
Baseline, Day 30, Day 60, and Day 90.
|
|
Change in Waist Circumference
Time Frame: Baseline, Day 7, Day 30, Day 60, and Day 90.
|
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
Time Frame: Baseline, Day 7, Day 30, Day 60, and Day 90.
|
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
Time Frame: Baseline, Day 7, Day 30, Day 60, and Day 90.
|
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
Time Frame: Baseline, Day 7, Day 30, Day 60, and Day 90.
|
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)
Time Frame: Baseline, Day 30, Day 60, and Day 90.
|
Change in serum alanine aminotransferase concentration measured by hepatic function panel.
|
Baseline, Day 30, Day 60, and Day 90.
|
|
Change in Aspartate Aminotransferase (AST)
Time Frame: Baseline, Day 30, Day 60, and Day 90
|
Change in serum aspartate aminotransferase concentration measured by hepatic function panel.
|
Baseline, Day 30, Day 60, and Day 90
|
|
Change in Alkaline Phosphatase (ALP)
Time Frame: Baseline, Day 30, Day 60, and Day 90.
|
Change in serum alkaline phosphatase concentration measured by hepatic function panel.
|
Baseline, Day 30, Day 60, and Day 90.
|
|
Change in Total Bilirubin
Time Frame: Baseline, Day 30, Day 60, and Day 90.
|
Change in serum total bilirubin concentration measured by hepatic function panel.
|
Baseline, Day 30, Day 60, and Day 90.
|
|
Change in Total Cholesterol
Time Frame: Baseline, Day 30, Day 60, and Day 90.
|
Change in serum total cholesterol concentration measured by lipid panel.
|
Baseline, Day 30, Day 60, and Day 90.
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Participant-Reported Bloating Severity
Time Frame: Baseline, Day 1, Day 3, Day 7, Day 30, Day 60, and Day 90.
|
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
Time Frame: Baseline, Day 1, Day 3, Day 7, 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
Time Frame: Baseline, Day 1, Day 3, Day 7, Day 30, Day 60, and Day 90.
|
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
Time Frame: Baseline, Day 1, Day 3, Day 7, Day 30, Day 60, and Day 90.
|
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
Time Frame: Baseline, Day 1, Day 3, Day 7, Day 30, Day 60, and Day 90.
|
Change in participant-reported skin health assessed by study questionnaire.
|
Baseline, Day 1, Day 3, Day 7, Day 30, Day 60, and Day 90.
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- #20758
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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