Studerer hedonisk og homeostatisk regulering av matinntak ved bruk av funksjonell MR
Fysiologisk regulering av energiinntak - FOOD-PRINT-studien som identifiserer de hormonelle og nevrale fotavtrykkene til de visceroceptive, homeostatiske og hedoniske komponentene i matinntaksregulering hos mennesker
The purpose of this study is to investigate how gut hormones and brain areas respond differently to gastric distention, tasteless calories, or palatable food and how this alters appetite.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic Rochester
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- BMI 18-25 kg/m^2.
- Weight stable for 3 months prior to study entry.
- For females: study days will be scheduled during the follicular phase of their menstrual cycle (i.e., the first 13 days (about 2 weeks) of the cycle).
- Able to provide written informed consent prior to any study procedures and be willing and able to follow study procedures..
- Ability to perform light to moderate physical activity.
Exclusion Criteria:
- Any contraindication for MRI scanning.
- Any history of childhood (> 95th percentile) or adult obesity (BMI >30 kg/m^2).
- Claustrophobia.
- High intensity training or physical activity.
- Any contraindication for intragastric balloon insertion.
- Any allergies to the study meals.
- Any history of eating disorder.
- Any substance abuse disorder (including alcohol and tobacco).
- Any history of psychiatric disorders.
- Any cardiovascular, endocrine, pulmonary, neurological, or gastrointestinal comorbidities.
- Pregnancy or nursing.
- Any history of bariatric surgery or endoscopic bariatric procedure.
- Use of any medication or supplement that alters appetite.
- Patient has a known history of any condition or factor judged by the investigator to prevent participation in the study or which might hinder study adherence.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: Food-Print Main Arm
Functional Magnetic Resonance Imaging (pCASL-MRI) after Caloric and Volumetric stimulus in lean patients will be performed on all patients in the study |
MRI's will be performed at multiple points on each visit day. Intragastric Balloon will be placed during Visit 2 study day and inflated to maximum tolerated volume. Patient will then be scanned in the MRI.
Andre navn:
Patient will ingest the tasteless elemental meal until their maximum level of fullness. Once full, the patient will be scanned in the MRI. Patient will ingest meal of their choice from a local food delivery service and eat until they reach their maximum level of fullness. Once full, the patient will be scanned in the MRI |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Difference in Cerebral Blood Flow related to hypothalamus
Tidsramme: 1 month
|
The mean difference in cerebral blood flow (CBF) at fullness (satiation) and return to hunger (satiety) to the hypothalamic area. |
1 month
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cerebral Bloodflow related in multiple brain areas
Tidsramme: 1 month
|
The mean difference in cerebral blood flow (CBF) at fullness (satiation) and return to hunger (satiety) to the other brain areas related to food intake regulation. |
1 month
|
|
Cerebral Blood Flow between three stimuli
Tidsramme: 1 month
|
The mean difference in cerebral blood flow (CBF) between the 3 different stimuli. |
1 month
|
|
Hormone level
Tidsramme: 1 month
|
Differences in hormones levels (ghrelin, GLP-1, CCK, PYY, leptin, insulin, GIP, amylin) at each of the stages (I.e., baseline, fullness, maximal fullness) after the three different stimulations. These hormones will be compared before and after the same stimulation days. The hormone measurements on stimulation days will also be compared to each other. |
1 month
|
|
comparison of calories
Tidsramme: 1 month
|
Correlation the caloric consumption to fullness, maximal fullness with degree of cerebral blood flow(CBF) change on PASL MRI. |
1 month
|
|
calorie corellation to hormones
Tidsramme: 1 month
|
Correlation the caloric consumption to fullness, maximal fullness with changes in the hormonal levels (ghrelin, GLP-1, CCK, PYY, leptin, insulin, GIP, amylin). |
1 month
|
|
hormone level comparison
Tidsramme: 1 month
|
Differences in the hormonal levels (ghrelin, GLP-1, CCK, PYY, leptin, insulin, GIP, amylin) between fullness and hunger after the three different stimulations. These hormones will be compared before and after the same stimulation days. The hormone measurements on stimulation days will also be compared to each other. |
1 month
|
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Time differences in stimuli
Tidsramme: 1 month
|
Differences in time to next meal after maximal fullness after the three different stimulations. |
1 month
|
|
Caloric consumption differences in stimuli
Tidsramme: 1 month
|
Differences in the caloric consumption after maximal fullness after the three different stimulations. |
1 month
|
|
FitBit measured Physical Activity
Tidsramme: 1 month
|
Measurement of daily physical activity during free-living conditions measured through the use of FitBit tracker over the duration of the study. |
1 month
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Andres Acosta, MD, PhD, Mayo Clinic
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 21-010514
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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