Appetite Regulation in Older-Aged Obese Individuals
4. januar 2021 opdateret af: University of Colorado, Denver
This study plans to learn more about how age and weight impact appetite and food intake.
Specifically, this study is being done to see whether age and obesity impact appetite and the brain's response to food.
In this study the investigators will be evaluating how participants brains respond to food images as well as your food-related behaviors and hormones.
The investigators will be comparing older individuals aged 65 to 85 years who are normal weight compared to those who are obese.
The Investigators will then compare older aged individuals to younger adults aged 21 to 45 years.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
In a cross sectional design participants will be studied on one occasion after a 3-day diet run-in.
On the study day they will present in the fasting state, have an intravenous catheter placed for blood draws and have baseline blood samples taken and appetite measures performed.
Participants will then undergo functional magnetic resonance imaging (fMRI).
This will be followed by a breakfast meal.
Blood and appetite measures will be performed every half hour for 3 hours.
Repeat fMRI will be performed 30 minutes after the meal.
After three hours participants will be offered a buffet style lunch and then will be done with the study visit.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
37
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Colorado
-
Aurora, Colorado, Forenede Stater, 80045
- Univeristy of Colorado
-
-
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 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Older aged adults (O): 65-85
- Younger adults (Y): 21-45
- Obese (Ob): body mass index (BMI) 30-40
- Normal Weight (NW): BMI 18-25
Exclusion Criteria:
- Pregnancy;
- Advanced organ failure;
- Active cancer diagnosis;
- Uncontrolled hypertension or metabolic disorder;
- Cognitive impairment or psychiatric disease limiting ability to comply;
- Presently in an exercise or diet program;
- Recent weight loss of >5 lbs in past 6 mo.;
- Bariatric surgery;
- Use of any weight loss drugs;
- Use of any medication known to significantly affect appetite (anti-depressants are allowable);
- Present tobacco use;
- Use/abuse of substances of abuse including any marijuana use by history;
- Any contraindication to MRI;
- Claustrophobia;
- Body weight >300 lbs; and
- Inability to fit in MRI scanner.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: obese older aged, aged 65-85, BMI 30-40
Older aged patients who are obese and between the ages of 65-85 with a BMI between 30-40.
|
Participants will be studied on one occasion after a 3-day diet run-in.
This will be followed by a breakfast meal.
After a 3-day diet run-in, participants will undergo a functional magnetic resonance imaging procedure (fMRI).
Repeat fMRI will be performed 30 minutes after the meal.
Andre navne:
On the study day participants will present in the fasting state, have an intravenous catheter placed for blood draws and have baseline blood samples taken.
Blood and appetite measures will be performed every half hour for 3 hours.
Andre navne:
|
|
Aktiv komparator: normal weight older aged, aged 65-85, BMI 18-25
Older aged patients who are of normal weight and between the ages of 65-85 with a BMI between 18-25.
|
Participants will be studied on one occasion after a 3-day diet run-in.
This will be followed by a breakfast meal.
After a 3-day diet run-in, participants will undergo a functional magnetic resonance imaging procedure (fMRI).
Repeat fMRI will be performed 30 minutes after the meal.
Andre navne:
On the study day participants will present in the fasting state, have an intravenous catheter placed for blood draws and have baseline blood samples taken.
Blood and appetite measures will be performed every half hour for 3 hours.
Andre navne:
|
|
Aktiv komparator: obese younger aged, aged 21-45, BMI 30-40
Younger aged patients who are obese and between the ages of 21-45 with a BMI between 30-40 .
|
Participants will be studied on one occasion after a 3-day diet run-in.
This will be followed by a breakfast meal.
After a 3-day diet run-in, participants will undergo a functional magnetic resonance imaging procedure (fMRI).
Repeat fMRI will be performed 30 minutes after the meal.
Andre navne:
On the study day participants will present in the fasting state, have an intravenous catheter placed for blood draws and have baseline blood samples taken.
Blood and appetite measures will be performed every half hour for 3 hours.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
neuronal response to food images
Tidsramme: 1 day
|
fMRI of brain will be done in response to images of food
|
1 day
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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 (Faktiske)
1. maj 2016
Primær færdiggørelse (Faktiske)
31. oktober 2020
Studieafslutning (Faktiske)
31. oktober 2020
Datoer for studieregistrering
Først indsendt
21. marts 2016
Først indsendt, der opfyldte QC-kriterier
23. marts 2016
Først opslået (Skøn)
29. marts 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. januar 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. januar 2021
Sidst verificeret
1. januar 2021
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 15-1511
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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 .