A Clinical Trial to Evaluate the Effects of a Plant-Based Liquid Supplement on Metabolic Health and Overall Well-Being

Biocol Labs20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metabolic Health Elevated Liver Enzymes Digestive Symptoms

Interventions

Eligibility

Sex: ALLMin age: 40 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in Body Weight

Change in body weight measured using a Withings smart scale.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, Day 30, Day 60, and Day 90.

Change in Aspartate Aminotransferase (AST)

Change in serum aspartate aminotransferase concentration measured by hepatic function panel.

Time frame: Baseline, Day 30, Day 60, and Day 90

Change in Alkaline Phosphatase (ALP)

Change in serum alkaline phosphatase concentration measured by hepatic function panel.

Time frame: Baseline, Day 30, Day 60, and Day 90.

Change in Total Bilirubin

Change in serum total bilirubin concentration measured by hepatic function panel.

Time frame: Baseline, Day 30, Day 60, and Day 90.

Change in Total Cholesterol

Change in serum total cholesterol concentration measured by lipid panel.

Time frame: Baseline, Day 30, Day 60, and Day 90.

Secondary Outcomes

Change in Participant-Reported Bloating Severity

Change in participant-reported bloating severity assessed by study questionnaire.

Time frame: Baseline, Day 1, Day 3, Day 7, Day 30, Day 60, and Day 90.

Change in Participant-Reported Flatulence Severity

Change in participant-reported flatulence severity assessed by study questionnaire.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, Day 1, Day 3, Day 7, Day 30, Day 60, and Day 90.

A Clinical Trial to Evaluate the Effects of a Plant-Based Liquid Supplement on Metabolic Health and Overall Well-Being

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes