- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07625202
Creatine Supplementation During GLP-1a Therapy
30. maj 2026 opdateret af: Phil Chilibeck, University of Saskatchewan
A Pilot Study on Creatine Supplementation During Resistance-training for Prevention of Lean Tissue Mass Loss During GLP-1 Receptor Agonist Therapy
GLP-1 receptor agonists are effective for weight loss, but significant muscle mass is lost as a proportion of this weight loss.
This study combines resistance-training and creatine supplementation to try to prevent this loss of muscle mass.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
GLP-1 receptor agonists are highly effective for weight loss and increasing in popularity for those trying to lose weight.
One concern with these medications is the potential for loss of lean tissue mass during rapid weight loss.
This may affect strength and functional performance in people taking these medications.
Resistance-training helps to offset loss of muscle mass during weight loss.
Supplementation with creatine monohydrate is also effective for improving muscle mass and strength.
The purpose of this pilot study is to determine the effectiveness of creatine supplementation during a resistance training program in people who are starting GLP-receptor agonist medication for preventing loss of lean tissue mass and functional performance.
The investigators will randomize 40 people who are starting GLP-1 agonists to receive either 10g per day creatine or placebo during a resistance-training program (i.e., resistance-training three days per week for 12 weeks).
It is hypothesized that participants on the creatine supplement will have superior maintenance of lean tissue mass and function performance compared to participants taking placebo.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
40
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Philip D Chilibeck, PhD
- Telefonnummer: 306-966-1072
- E-mail: phil.chilibeck@usask.ca
Studiesteder
-
-
SK - Saskatchewan
-
Saskatoon, SK - Saskatchewan, Canada, S7N 5B2
- Rekruttering
- University of Saskatchewan
-
Kontakt:
- Philip D Chilibeck, PhD
- Telefonnummer: 306-966-1072
- E-mail: phil.chilibeck@usask.ca
-
-
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
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Starting GLP-1 agonist therapy
- 18 years of age or older
Exclusion Criteria:
- Positive answers to a screening questionnaire for physical activity safety (the Get Active Questionnaire)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
Placebo (maltodextrin)
|
Placebo
|
|
Eksperimentel: Creatine
10 grams per day creatine
|
creatine supplementation
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in sit to stand performance (number of times)
Tidsramme: 12 weeks
|
change in number of times sitting and standing in 30 seconds
|
12 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in 10 meter gait speed (m/s)
Tidsramme: 12 weeks
|
change in walking speed over 10 meters
|
12 weeks
|
|
Change in timed up and go (m/s)
Tidsramme: 12 weeks
|
change in time to stand up, walk 3m, turn, around, walk 3 m and sit down
|
12 weeks
|
|
Change in lean tissue mass (kg)
Tidsramme: 12 weeks
|
Change in lean tissue mass as determined by dual energy x-ray absorptiometry
|
12 weeks
|
|
Change in fat mass (kg)
Tidsramme: 12 weeks
|
Change in fat mass as determined by dual energy x-ray absorptiometry
|
12 weeks
|
|
Change in whole body bone mineral density (g/cm squared)
Tidsramme: 12 weeks
|
Change in bone mineral density as determined by dual energy x-ray absorptiometry
|
12 weeks
|
|
Change in femoral neck bone mineral density (g/cm squared)
Tidsramme: 12 weeks
|
Change in bone mineral density as determined by dual energy x-ray absorptiometry
|
12 weeks
|
|
Change in total hip bone mineral density (g/cm squared)
Tidsramme: 12 weeks
|
Change in bone mineral density as determined by dual energy x-ray absorptiometry
|
12 weeks
|
|
Change in lumbar spine bone mineral density (g/cm squared)
Tidsramme: 12 weeks
|
Change in bone mineral density as determined by dual energy x-ray absorptiometry
|
12 weeks
|
|
Change in hip section modulus (cm-cubed)
Tidsramme: 12 weeks
|
Change in hip section modulus as determined by dual energy x-ray absorptiometry
|
12 weeks
|
|
Change in muscle thickness of the biceps (cm)
Tidsramme: 12 weeks
|
Change in muscle thickness measured by ultrasound
|
12 weeks
|
|
Change in muscle thickness of the quadriceps (cm)
Tidsramme: 12 weeks
|
Change in muscle thickness measured by ultrasound
|
12 weeks
|
|
Change in bench press strength (kg)
Tidsramme: 12 weeks
|
change in upper body strength measured by predicted one repetition maximum
|
12 weeks
|
|
Change in leg extension strength (kg)
Tidsramme: 12 weeks
|
Change in lower body strength measured by predicted one repetition maximum
|
12 weeks
|
|
Change in hip buckling ratio (ratio)
Tidsramme: 12 weeks
|
Change in hip buckling ratio as determined by dual energy x-ray absorptiometry
|
12 weeks
|
|
Change in hip cross-sectional area (cm-squared)
Tidsramme: 12 weeks
|
Change in hip cross-sectional area as determined by dual energy x-ray absorptiometry
|
12 weeks
|
|
Change in hip cortical thickness (cm)
Tidsramme: 12 weeks
|
Change in hip cortical thickness as determined by dual energy x-ray absorptiometry
|
12 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Philip Chilibeck, PhD, University of Saskatchewan
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)
25. maj 2026
Primær færdiggørelse (Anslået)
30. maj 2027
Studieafslutning (Anslået)
31. december 2027
Datoer for studieregistrering
Først indsendt
25. maj 2026
Først indsendt, der opfyldte QC-kriterier
30. maj 2026
Først opslået (Faktiske)
4. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Sygdomme i nervesystemet
- Neuromuskulære manifestationer
- Patologiske Tilstande, Anatomiske
- Muskelatrofi
- Atrofi
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Sarkopeni
- Aminosyrer, peptider og proteiner
- Organiske kemikalier
- Aminosyrer
- Guanidiner
- Amidiner
- Kreatin
Andre undersøgelses-id-numre
- 6372
Plan for individuelle deltagerdata (IPD)
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