- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00798668
The Body's Response to Food Intake in Trained, Older Adults
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Indiana
-
West Lafayette, Indiana, Vereinigte Staaten, 47907
- Purdue University
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 1
participants continue current exercise and take liquid supplement
|
Liquid supplement that provides 12.5% of the subjects total energy requirement.
|
|
Experimental: 2
Participants continue current exercise and take solid supplement
|
Solid supplement that provides 12.5% of the subjects total energy requirement.
|
|
Experimental: 3
Participants continue current sedentary behavior and take liquid supplements
|
Liquid supplement that provides 12.5% of the subjects total energy requirement.
|
|
Experimental: 4
Participants continue current sedentary behavior and take solid supplements
|
Solid supplement that provides 12.5% of the subjects total energy requirement.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
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.
Zeitfenster: 6 weeks
|
6 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
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
Zeitfenster: 6 weeks
|
6 weeks
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 0607004184
- NIH R01 AG021911-0102
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