- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07673432
A Clinical Trial to Evaluate the Effects of a Plant-Based Liquid Supplement on Metabolic Health and Overall Well-Being
23. juni 2026 opdateret af: Biocol Labs
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.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
20
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Nevada
-
Las Vegas, Nevada, Forenede Stater, 89118
- Citruslabs
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Body Weight
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Participant-Reported Bloating Severity
Tidsramme: 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.
|
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Change in Participant-Reported Flatulence Severity
Tidsramme: 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.
|
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Change in Participant-Reported Heartburn Severity
Tidsramme: 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.
|
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Change in Participant-Reported Digestive Comfort
Tidsramme: 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.
|
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Change in Participant-Reported Skin Health
Tidsramme: 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.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
5. juni 2025
Primær færdiggørelse (Faktiske)
15. januar 2026
Studieafslutning (Faktiske)
15. januar 2026
Datoer for studieregistrering
Først indsendt
23. juni 2026
Først indsendt, der opfyldte QC-kriterier
23. juni 2026
Først opslået (Faktiske)
29. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- #20758
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