- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07673432
A Clinical Trial to Evaluate the Effects of a Plant-Based Liquid Supplement on Metabolic Health and Overall Well-Being
23 juni 2026 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
20
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Nevada
-
Las Vegas, Nevada, Förenta staterna, 89118
- Citruslabs
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Body Weight
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Participant-Reported Bloating Severity
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
5 juni 2025
Primärt slutförande (Faktisk)
15 januari 2026
Avslutad studie (Faktisk)
15 januari 2026
Studieregistreringsdatum
Först inskickad
23 juni 2026
Först inskickad som uppfyllde QC-kriterierna
23 juni 2026
Första postat (Faktisk)
29 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- #20758
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .