- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05034380
Epigenetic Effects of a Single Bout of Exercise on Cardiovascular Risk Factors and the Metabolome
28. august 2021 oppdatert av: Jessica Ellis, East Carolina University
Epigenetic Effects of a Single Bout of Exercise on Cardiovascular Risk Factors and the Metabolome in Lean and Overweight or Obese Subjects
The purpose of this study is to determine the ability of acute exercise to regulate fat metabolism in muscle of overweight and obese people compared to lean people.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
After being informed about the study details and possible risks and benefits, 15 overweight/obese and 15 lean participants gave written informed consent and were then screened and enrolled in the study.
All participants then gave a muscle sample and ate a calorically controlled breakfast.
Participants completed ~1 hour of cycling exercise on a stationary bike and gave a second muscle sample 4 hours after eating breakfast.
Studietype
Intervensjonell
Registrering (Faktiske)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Indiana
-
West Lafayette, Indiana, Forente stater, 47907
- Purdue University
-
-
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
18 år til 30 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- healthy males that completed a physical examination with a State Licensed M.D. or D.O. within the past 2 years and completed a physical activity readiness questionnaire (PARQ), the International Physical Activity Questionnaires (IPAQ) and and a medical history questionnaire prior to the study
Exclusion Criteria:
- any participants that had not had a physical examination by a State Licensed M.D. or D.O. within the past 2 years
- persons not considered "healthy" (with any previous medical diagnoses) or not medically cleared by a M.D. or D.O. to perform physical activity/exercise
- persons who are regularly physically active
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Lean
males aged 18-30 years with BMI < 25
|
All participants consumed a standardized, high carbohydrate meal (7 kcal/kg; 60% carbohydrate, 25% fat, 15% protein) and completed an exercise testing trial, expending a total of 650 kcal upon completion 4h later.
|
|
Eksperimentell: Overweight/Obese
males aged 18-30 years with BMI >= 25
|
All participants consumed a standardized, high carbohydrate meal (7 kcal/kg; 60% carbohydrate, 25% fat, 15% protein) and completed an exercise testing trial, expending a total of 650 kcal upon completion 4h later.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in skeletal muscle acylcarnitines
Tidsramme: Baseline and immediately after acute cycling exercise
|
Metabolomics of skeletal muscle acylcarnitines is used as a measure of mitochondrial function by assessing long, medium and short chain acylcarnitine levels.
|
Baseline and immediately after acute cycling exercise
|
|
Change from baseline in skeletal transcriptome
Tidsramme: Baseline and immediately after acute cycling exercise
|
RNA-seq is a method used to quantify changes in all known messenger RNA levels in the genome, giving an assessment of whole genome gene transcription changes.
|
Baseline and immediately after acute cycling exercise
|
|
Change from baseline in skeletal muscle whole genome nucleosome maps
Tidsramme: Baseline and immediately after acute cycling exercise
|
MNase-seq is a method used to determine the occupancy/location of nucleosomes throughout the entire genome, supporting evidence of alterations in epigenetic modifications occurring at specific genomic loci that affect nucleosome occupancy/location and possibly gene transcription or silencing.
|
Baseline and immediately after acute cycling exercise
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Glucose
Tidsramme: Baseline and immediately after acute cycling exercise
|
Commercially validated and available colorimetric used to determine plasma glucose levels.
|
Baseline and immediately after acute cycling exercise
|
|
Insulin
Tidsramme: Baseline and immediately after acute cycling exercise
|
Commercially validated and available ELISAs used to determine plasma insulin levels.
|
Baseline and immediately after acute cycling exercise
|
|
Triglycerides
Tidsramme: Baseline and immediately after acute cycling exercise
|
Commercially validated and available colorimetric kits used to determine plasma triglyceride levels.
|
Baseline and immediately after acute cycling exercise
|
|
Free fatty acids
Tidsramme: Baseline and immediately after acute cycling exercise
|
Commercially validated and available colorimetric kits used to determine plasma free fatty acid levels.
|
Baseline and immediately after acute cycling exercise
|
|
Cholesterol
Tidsramme: Baseline and immediately after acute cycling exercise
|
Commercially validated and available colorimetric kits used to determine total cholesterol, HDL, LDL and VLDL levels in plasma.
|
Baseline and immediately after acute cycling exercise
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Tara Henagan, PhD, Purdue University, Louisiana State University Medical School at Shreveport
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)
14. september 2014
Primær fullføring (Faktiske)
6. oktober 2015
Studiet fullført (Faktiske)
14. mars 2016
Datoer for studieregistrering
Først innsendt
16. september 2020
Først innsendt som oppfylte QC-kriteriene
28. august 2021
Først lagt ut (Faktiske)
5. september 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. september 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. august 2021
Sist bekreftet
1. august 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AcuteExerciseNucleo
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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