- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00798668
The Body's Response to Food Intake in Trained, Older Adults
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Indiana
-
West Lafayette, Indiana, Forente stater, 47907
- Purdue University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
All subjects must meet the following eligibility criteria:
- Age range: 60 years and older
- Body mass index between 20-29 kg/m2
- Weight stable (< 2 kg weight change within last 6 months)
- Non-smoking
- Constant habitual activity patterns within last 3 months
- Clinically normal blood profiles (specifically, normal liver and kidney function; normal complete blood count (non-anemic); fasting blood glucose <110 mg/dl)
- Not taking medications known to influence appetite or metabolism
- Non-diabetic
- Confirmation of acceptability of eating the study test foods (solids and fluids)
Trained subjects (Recruiting 36; N-25) must meet the following eligibility criteria:
- Resistive exercise training (≥ 2 times a week) based on reported physical activity levels (questionnaire)
- Active fitness level (≥ 2, 30-minute aerobic exercise sessions/week)
Sedentary subjects (Recruiting 36; N-25) must meet the following eligibility criteria:
- Resistive exercise training (≤ 1 time a week) based on reported physical activity levels (questionnaire)
- Active fitness level (≤ 2, 30-minute aerobic exercise sessions/week)
Exclusion Criteria:
All subjects will be excluded based on the following exclusionary criteria:
- Age: <60 years
- Body mass index: outside of the 20-29 kg/m2 range
- Gained or lost > 4.5 kg within the last 6 months
- Smoker (currently or within the last year)
- Intermittently been involved in a diet and/or exercise program within the last 3 months
- Clinically abnormal blood profiles as identified by our study physician, Arthur Rosen, MD
- Taking medications (currently or within the last 3 months) known to influence appetite or metabolism
- Abnormal heart function (interpreted by a cardiologist) and assessed (for study exclusion) by our study physician, Arthur Rosen, MD
- Clinically diagnosed as diabetic
- Study foods are found to be unacceptable for consumption by the subject
- Clinically diagnosed osteoporosis
Trained subjects will be excluded based on the following exclusionary criteria:
- Did not perform resistive exercise training (currently or within the last 3 months) based on reported physical activity levels (questionnaire)
- Perform ≤ 1, 30-minute aerobic exercise session/week (currently or within the last 3 months) based on physical activity levels questionnaire)
Sedentary subjects will be excluded based on the following exclusionary criteria:
- Performed resistive exercise training (currently or within the last 3 months) based on reported physical activity levels (questionnaire)
- Perform > 2, 30-minute aerobic exercise sessions/week (currently or within the last 3 months) based on physical activity levels questionnaire)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 1
participants continue current exercise and take liquid supplement
|
Liquid supplement that provides 12.5% of the subjects total energy requirement.
|
Eksperimentell: 2
Participants continue current exercise and take solid supplement
|
Solid supplement that provides 12.5% of the subjects total energy requirement.
|
Eksperimentell: 3
Participants continue current sedentary behavior and take liquid supplements
|
Liquid supplement that provides 12.5% of the subjects total energy requirement.
|
Eksperimentell: 4
Participants continue current sedentary behavior and take solid supplements
|
Solid supplement that provides 12.5% of the subjects total energy requirement.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Quantify the acute effects of fluid and solid foods on post-prandial (post-meal) appetite and food intake at the next eating occasion in trained and untrained, elderly people.
Tidsramme: 6 weeks
|
6 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Quantify the contribution of selected satiety factors (glucose, insulin, CCK, ghrelin, and GLP-1) and gastrointestinal transit time, to the differential appetitive responses to fluid versus solid foods in trained and untrained, elderly people
Tidsramme: 6 weeks
|
6 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 0607004184
- NIH R01 AG021911-0102
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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