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Fat Metabolism in Response to Acute Diet- and Exercise-induced Changes in Energy Balance (DEV)

18. januar 2013 oppdatert av: Washington University School of Medicine

VLDL-triglyceride Metabolism in Response to Acute Diet- and Exercise-induced Changes in Energy Balance

This study is being conducted to learn more about the role of diet and exercise in regulating plasma triglyceride (fat) metabolism. The investigators will examine the effect of acute (24 hour) changes in energy intake and expenditure on fat metabolism the following day.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Excess body fat and a sedentary lifestyle are associated with increased plasma triglyceride (TG) and apolipoprotein B-100 (apoB-100) concentrations, which are important risk factors for the development of cardiovascular disease.

Weight loss and endurance exercise improve plasma lipid and lipoprotein concentrations. However, the mechanisms responsible for this effect are largely unknown, and much uncertainty remains regarding the independent roles of dietary energy intake, exercise energy expenditure, and net energy balance in controlling plasma TG concentrations.

The main goal of this project, therefore, is to investigate the mechanisms by which acute alterations in energy balance, induced by diet and/or physical activity (endurance exercise), regulate very-low density lipoprotein (VLDL) metabolism.

Subjects will be asked to perform 3 separate trials. One of these will always be an "energy balance" trial that will act as the control trial for the other 2 trials they perform. Subjects will therefore be randomized to 2 different study arms.

Studietype

Intervensjonell

Registrering (Faktiske)

12

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
    • Missouri
      • Saint Louis, Missouri, Forente stater, 63110
        • Washington University in Saint Louis

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

21 år til 50 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

Inclusion Criteria:

  • overweight and obese men
  • normal to mild hypertriglyceridemia

Exclusion Criteria:

  • Smoking
  • Any medical condition other than increased body weight (e.g. diabetes, heart disease, etc.).
  • Use of drugs known to affect lipid metabolism (e.g. statins, etc.).
  • Regular exercise training.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Positive energy balance
Comparison between isocaloric and hypercaloric diets with no exercise performed in any trials
Atferdsmessig: Positive energy balance
Subjects will consume over a 24 hour period 33% more calories than they require to meet their energy demands.
Atferdsmessig: Energy balance
Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.
Eksperimentell: Energy balance with exercise
Comparison between an isocaloric diet without exercise and a hypercaloric diet with a sufficient amount of exercise performed to match the excess calories consumed resulting in both trials being in net energy balance.
Atferdsmessig: Energy balance
Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.
Atferdsmessig: Energy balance with exercise
Subjects will consume over a 24 hour period 33% more calories than they require to meet their energy demands but will perform 2 hours of exercise that will be sufficient to burn off the excess calories consumed resulting in subjects being in net energy balance.
Eksperimentell: Negative energy balance
Comparison between isocaloric and hypocaloric diets with no exercise performed in any trials
Atferdsmessig: Energy balance
Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.
Atferdsmessig: Negative energy balance
Subjects will consume over a 24 h period only 66% of the calories required to meet their energy demands such that they will be in a net negative calorie balance in this trial.
Eksperimentell: Negative energy balance with exercise
Comparison between consuming an isocaloric diet without exercise and consuming the same amount of calories as in the isocaloric trial but with exercise performed resulting in net negative energy balance in the exercise trial.
Atferdsmessig: Energy balance
Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.
Atferdsmessig: Negative energy balance with exercise
Subjects will consume over a 24 hour period the same amount of calories as ingested in the isocaloric trial but will also perform 2 hours of exercise that will be sufficient to burn off a third of the calories they consumed during this day resulting in subjects being in net negative energy balance in this trial

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Very Low Density Lipoprotein-Triglyceride and apoB-100 concentrations
Tidsramme: After acute (24 hour) changes in energy intake and/or energy expenditure
After acute (24 hour) changes in energy intake and/or energy expenditure

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Liver Very Low Density Lipoprotein-Triglyceride and apoB-100 secretion rates
Tidsramme: After acute (24 hour) changes in energy intake and/or energy expenditure
After acute (24 hour) changes in energy intake and/or energy expenditure
Liver Very Low Density Lipoprotein-Triglyceride and apoB-100 clearance rates from plasma
Tidsramme: After acute (24 hour) changes in energy intake and/or energy expenditure
After acute (24 hour) changes in energy intake and/or energy expenditure
Plasma glucose concentration and turnover rate
Tidsramme: After acute (24 hour) changes in energy intake and/or energy expenditure
After acute (24 hour) changes in energy intake and/or energy expenditure
Plasma insulin concentration
Tidsramme: After acute (24 hour) changes in energy intake and/or energy expenditure
After acute (24 hour) changes in energy intake and/or energy expenditure
Plasma free fatty acid concentration and turnover rate
Tidsramme: After acute (24 hour) changes in energy intake and/or energy expenditure
After acute (24 hour) changes in energy intake and/or energy expenditure
Plasma glucose concentration
Tidsramme: During acute (24 hour) changes in energy intake and/or energy expenditure
Measured hourly over the 24 h period.
During acute (24 hour) changes in energy intake and/or energy expenditure
Plasma insulin concentration
Tidsramme: During acute (24 hour) changes in energy intake and/or energy expenditure
Measured hourly over the 24 h period.
During acute (24 hour) changes in energy intake and/or energy expenditure
Plasma free fatty acid concentration
Tidsramme: During acute (24 hour) changes in energy intake and/or energy expenditure
Measured hourly over the 24 h period.
During acute (24 hour) changes in energy intake and/or energy expenditure

Samarbeidspartnere og etterforskere

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

Sponsor

Washington University School of Medicine

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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

1. april 2006

Primær fullføring (Faktiske)

1. desember 2012

Studiet fullført (Faktiske)

1. desember 2012

Datoer for studieregistrering

Først innsendt

26. januar 2009

Først innsendt som oppfylte QC-kriteriene

26. januar 2009

Først lagt ut (Anslag)

28. januar 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

21. januar 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. januar 2013

Sist bekreftet

1. januar 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 05-0195

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