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

23. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89118
        • Citruslabs

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Kosttilskudd: Plant-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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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.
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.
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.
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.
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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Biocol Labs

Samarbeidspartnere

Citruslabs

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. juni 2025

Primær fullføring (Faktiske)

15. januar 2026

Studiet fullført (Faktiske)

15. januar 2026

Datoer for studieregistrering

Først innsendt

23. juni 2026

Først innsendt som oppfylte QC-kriteriene

23. juni 2026

Først lagt ut (Faktiske)

29. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • #20758

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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