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

18. januar 2013 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

12

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Washington University in Saint Louis

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

21 år til 50 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

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

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: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Positive energy balance
Comparison between isocaloric and hypercaloric diets with no exercise performed in any trials
Adfærdsmæssigt: Positive energy balance
Subjects will consume over a 24 hour period 33% more calories than they require to meet their energy demands.
Adfærdsmæssigt: Energy balance
Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.
Eksperimentel: 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.
Adfærdsmæssigt: Energy balance
Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.
Adfærdsmæssigt: 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.
Eksperimentel: Negative energy balance
Comparison between isocaloric and hypocaloric diets with no exercise performed in any trials
Adfærdsmæssigt: Energy balance
Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.
Adfærdsmæssigt: 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.
Eksperimentel: 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.
Adfærdsmæssigt: Energy balance
Subjects will consume over a 24 hour period a sufficient amount of calories to meet their energy needs.
Adfærdsmæssigt: 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

Hvad måler undersøgelsen?

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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Washington University School of Medicine

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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

1. april 2006

Primær færdiggørelse (Faktiske)

1. december 2012

Studieafslutning (Faktiske)

1. december 2012

Datoer for studieregistrering

Først indsendt

26. januar 2009

Først indsendt, der opfyldte QC-kriterier

26. januar 2009

Først opslået (Skøn)

28. januar 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. januar 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. januar 2013

Sidst verificeret

1. januar 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 05-0195

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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