- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07608016
A Study to Evaluate a Supplement Combination in Supporting Weight Loss, Metabolic Health, and Quality of Life (RESMRESG101)
A Consumer Study to Evaluate the Efficacy of a Postbiotic and Prebiotic Supplement Combination in Supporting Weight Loss, Metabolic Health, and Quality of Life
This consumer-use study evaluates the effects of a combined postbiotic and prebiotic supplement regimen on appetite control, cravings, metabolic health, energy, and quality of life in adults aged 18-65 years with a body mass index (BMI) between 25 and 30.
Participants will consume one capsule of resM™ GLP-1 Postbiotic and one scoop of resG prebeet ENERGY Prebiotic daily for 60 days. Data will be collected through daily check-ins, weekly surveys, and quality-of-life questionnaires administered through the Chloe mobile application.
The primary objective is to evaluate changes in appetite control and food cravings over 60 days of supplementation.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The GLP-1 Optimizer Bundle combines resM™ GLP-1 Postbiotic and resG prebeet ENERGY Prebiotic to support appetite control, cravings, metabolic health, energy, and lifestyle behaviors.
This is a prospective, open-label, single-arm consumer-use study conducted over 60 days in approximately 20 adults aged 18-65 years with BMI between 25 and 30.
Participants will consume:
one capsule of resM™ GLP-1 Postbiotic daily one scoop of resG prebeet ENERGY Prebiotic daily
Assessments will be collected electronically through the Chloe mobile application and include:
appetite and cravings surveys energy and mood assessments quality-of-life questionnaires lifestyle habit surveys consumer satisfaction assessments
The study aims to evaluate consumer-reported changes associated with daily supplementation and lifestyle guidance.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
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Alabama
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Birmingham, Alabama, Forenede Stater, 35203
- Able Biolabs, LLC
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
Adults aged 18-65 years BMI between 25 and 30 Generally healthy Willing to comply with study procedures Access to smartphone or internet-enabled device for electronic questionnaires
Exclusion Criteria Pregnant, planning pregnancy, or lactating History of bariatric surgery Prescription weight loss medication use within the past 90 days Current GLP-1 drug use History of substance abuse within the past 6 months Current use of supplements containing overlapping active ingredients Significant medical condition that may interfere with study participation or interpretation of results
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Active Supplement Bundle
resM™ GLP-1 Postbiotic, and resG prebeet ENERGY Prebiotic
|
Participants will take a combined dosage of prebiotic and postbiotic.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Appetite Control and Food Cravings Survey Scores Over 60 Days
Tidsramme: Baseline through Day 60
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Participant-reported appetite control and food cravings will be assessed using daily and weekly questionnaires administered through the Chloe mobile application.
Survey responses will evaluate changes in hunger, cravings, satiety, and eating behaviors over the study period.
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Baseline through Day 60
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Energy and Mood Survey Scores Over 60 Days
Tidsramme: Baseline through Day 60
|
Participant-reported energy levels and mood will be assessed using weekly questionnaires administered through the participant management application.
|
Baseline through Day 60
|
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Change in Quality-of-Life Questionnaire Responses Over 60 Days
Tidsramme: Baseline, Day 30, and Day 60
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Quality-of-life assessments will evaluate participant-reported physical well-being, lifestyle habits, and overall satisfaction during the study period.
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Baseline, Day 30, and Day 60
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Participant Satisfaction and Willingness to Continue Product Use at Day 60
Tidsramme: Day 60
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End-of-study surveys will assess participant satisfaction, perceived benefits, and willingness to continue using the supplement combination.
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Day 60
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ABL-032502
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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