Metabolic Flexibility as a Biomarker of Adaptation to Diet and Exercise Challenges
30 mei 2017 bijgewerkt door: William Rumpler, USDA Beltsville Human Nutrition Research Center
The objective is to develop a new metabolic flexibility biomarker, which has application in the study of changes diet and exercise on fuel management in humans.
The new biomarker involves the characterization of an individual's metabolic flexibility utilizing room calorimeters rather than the current method, which is based on glucose clamp data.
It is hypothesized that this new metabolic flexibility method will be a useful and noninvasive biomarker for measuring adaptation to exercise and diet challenges.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
16
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Maryland
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Beltsville, Maryland, Verenigde Staten, 20705
- USDA Beltsville Human Nutrition Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
22 jaar tot 35 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Males and Females
- Age 22 to 35 years at beginning of study
Exclusion Criteria:
- Women who have given birth during the previous 12 months
- Pregnant women or women who plan to become pregnant or become pregnant during the study
- Lactating women
- History or presence of diabetes, kidney disease, liver disease, certain cancers, gastrointestinal, pancreatic, other metabolic diseases, or malabsorption syndromes.
- History of bariatric or certain other surgeries related to weight control
- Smokers or other tobacco users (for at least 6 months prior to the start of the study)
- History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
- Volunteers who have lost 10% of body weight within the last 12 months or who plan to initiate a weight loss program during the next 10 months
- Unable or unwilling to give informed consent or communicate with study staff
- Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
- Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
- Inclusion and exclusion criteria have been established to recruit a population of individuals across a wide age-range that has typical digestive process
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: High Intensity Exercise, High Carbohydrate Beverage
Study participant consumes a high carbohydrate beverage as part of the day's meals, and performs high intensity exercise (85% of VO2 max), while in the calorimeter.
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While in the calorimeter, each subject will complete four bouts of exercise.
Each bout is approximately 5 minutes in duration at a predetermined speed and elevation to achieve an intensity of 85% of VO2 max according to their fitness level test described previously.
Subjects then sit quietly until either the next meal or the next exercise bout.
Participants will consume a high carbohydrate beverage (750 g) with the following composition: 2.13 MJ/d, 113g carbohydrate, 4g fat, 6g protein.
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Experimenteel: High Intensity Exercise, High Fat Beverage
Study participant consumes a high fat beverage as part of the day's meals, and performs high intensity exercise (85% of VO2 max), while in the calorimeter.
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While in the calorimeter, each subject will complete four bouts of exercise.
Each bout is approximately 5 minutes in duration at a predetermined speed and elevation to achieve an intensity of 85% of VO2 max according to their fitness level test described previously.
Subjects then sit quietly until either the next meal or the next exercise bout.
Participants will consume a high fat beverage (750 g) with the following composition: 2.11 MJ/d, 8g carbohydrate, 50g fat, 7g protein.
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Experimenteel: Low Intensity Exercise, High Carbohydrate Beverage
Study participant consumes a high carbohydrate beverage as part of the day's meals, and performs low intensity exercise (65% of VO2 max), while in the calorimeter.
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Participants will consume a high carbohydrate beverage (750 g) with the following composition: 2.13 MJ/d, 113g carbohydrate, 4g fat, 6g protein.
While in the calorimeter, each subject completes one exercise bout approximately 40 minutes in duration, at a predetermined speed and elevation, to achieve an intensity of 65% of VO2 max.
Subjects then sit quietly until the next meal.
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Experimenteel: Low Intensity Exercise, High Fat Beverage
Study participant consumes a high fat beverage as part of the day's meals, and performs low intensity exercise (65% of VO2 max), while in the calorimeter.
|
Participants will consume a high fat beverage (750 g) with the following composition: 2.11 MJ/d, 8g carbohydrate, 50g fat, 7g protein.
While in the calorimeter, each subject completes one exercise bout approximately 40 minutes in duration, at a predetermined speed and elevation, to achieve an intensity of 65% of VO2 max.
Subjects then sit quietly until the next meal.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Metabolic Flexibility by Room Calorimetry
Tijdsspanne: 24 hours
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Participants will stay in a room calorimeter for 24 hours where oxygen consumed and carbon dioxide produced will be measured.
Mathematical approaches will use continuous calorimetry data to generate consistent estimates of the gas exchange rates, and hence accurate "instantaneous" respiratory exchange ratios.
This novel approach allows evaluating the instantaneous dynamics of respiratory quotient noninvasively and for many different conditions (e.g., exercise and various nutrient ratios).
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24 hours
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Continuous Glucose Monitoring
Tijdsspanne: 24 hours
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Whole-day interstitial glucose profiles will be collected during each calorimeter measurement.
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24 hours
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 december 2012
Primaire voltooiing (Werkelijk)
1 september 2013
Studie voltooiing (Werkelijk)
1 september 2013
Studieregistratiedata
Eerst ingediend
12 november 2013
Eerst ingediend dat voldeed aan de QC-criteria
12 november 2013
Eerst geplaatst (Schatting)
19 november 2013
Updates van studierecords
Laatste update geplaatst (Werkelijk)
31 mei 2017
Laatste update ingediend die voldeed aan QC-criteria
30 mei 2017
Laatst geverifieerd
1 mei 2017
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- HS42
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .