- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01891617
Exercise Effects on Insulin, Gut Peptides, and Appetite (XFG)
The Exercise Effects on Appetite and Gut Peptides While on High-fat Diet
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Specific aim: Determine whether a change in macronutrient composition from 60% carbohydrate and 25% fat to 30% carbohydrate and 45% fat is responsible by itself for suppression of hunger and increased secretory response of glucose-dependent insulinotropic hormone (GIP) and glucagon-like peptide-1 (GLP-1), or whether these changes depend on preceding exercise. We will measure (a) concentrations of plasma GIP and GLP-1 by chemiluminescent multiplex assay, (b) concentrations of plasma ancetaminophen to assess the gastric emptying rate, (c) concentrations of plasma insulin, and glucagon by radioimmunoassay, and glucose, ketone bodies, and free fatty acids with appropriate spectrophotometric methods, (d) hourly appetite responses with visual analog scale under two conditions: sedentary (SED) and exercise (EX).
Hypothesis: Hunger suppression and secretion of GIP and GLP-1 after the morning meal will be greater with slower gastric emptying rate when a meal consisting of 45% fat and 30% carbohydrate follows three hours after a 2-hour bout of moderate-intensity exercise than in the absence of exercise.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Michigan
-
Ann Arbor, Michigan, Forenede Stater, 48109
- Michigan Clinical Research Unit
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Postmenopausal status
- Age 50 to 65 years
- BMI between 20 and 30 kg/m2.
- Good health status (normotensive, fasting glucose < 100 mg/dl, , hematocrit > 32%, hemoglobin >12 mg/dl)
- Absence of restricted food intake
- Absence of endocrine and metabolic disorders requiring medication other than hormonally corrected hypothyroidism
- Absence of musculoskeletal disabilities that would prevent walking
Exclusion Criteria:
- Presence of endocrine and metabolic disease requiring medication, other than hormonally corrected hypothyroidism
- Presence of musculoskeletal disabilities that would prevent walking
- Smoking
- Active dieting
- Absence of listed inclusion criteria
- Unwillingness to follow study protocol.
Studieplan
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 |
|---|---|
|
Eksperimentel: Exercise-high-fat diet
Two bouts of exercise followed by a high-fat meal
|
Exercise and high-fat diet Exercise and high-carbohydrate diet Sedentary and high-fat diet Sedentary and high-carbohydrate diet
|
|
Eksperimentel: Exercise-high-carbohydrate diet
Two bouts of exercise followed by a high-carbohydrate meal
|
Exercise and high-fat diet Exercise and high-carbohydrate diet Sedentary and high-fat diet Sedentary and high-carbohydrate diet
|
|
Eksperimentel: Sedentary-high-fat diet
Sedentary trial with two high-fat meals
|
Exercise and high-fat diet Exercise and high-carbohydrate diet Sedentary and high-fat diet Sedentary and high-carbohydrate diet
|
|
Eksperimentel: Sedentary-high-carbohydrate diet
Sedentary trial with two high-carbohydrate meals
|
Exercise and high-fat diet Exercise and high-carbohydrate diet Sedentary and high-fat diet Sedentary and high-carbohydrate diet
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Plasma insulin concentration
Tidsramme: 36 hours
|
Change in plasma insulin to two bouts of exercise followed by a high-carbohydrate or a high fat diet
|
36 hours
|
|
Plasma glucagon concentration
Tidsramme: 36 hours
|
Changes in plasma glucagon concentration to two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
|
36 hours
|
|
Plasma concentration of glucose-dependent insulinotropic peptide (GIP)
Tidsramme: 36 hours
|
Changes in plasma concentration of glucose-dependent insulinotropic peptide (GIP)to two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
|
36 hours
|
|
Plasma concentration of free fatty acids
Tidsramme: 36 hours
|
Changes in plasma concentration of free fatty acidsto two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
|
36 hours
|
|
Plasma concentration of beta-hydroxybutyrate
Tidsramme: 36 hours
|
Changes in plasma concentration of beta-hydroxybutyrate to two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
|
36 hours
|
|
Plasma glucose concentration
Tidsramme: 36 hours
|
Changes in plasma glucose concentration to two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
|
36 hours
|
|
daytime hourly appetite ratings
Tidsramme: 36 hours
|
Changes in daytime hourly appetite ratings to two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
|
36 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Plasma concentrations of glucagon-like peptide-1 (GLP-1)
Tidsramme: 36 hours
|
Changes in plasma concentrations of glucagon-like peptide-1 (GLP-1)to two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
|
36 hours
|
|
Plasma concentrations of peptide tyrosine tyrosine (PYY)
Tidsramme: 36 hours
|
Changes in plasma concentrations of peptide tyrosine tyrosine (PYY) to two bouts of exercise followed by either a high-carbohydrate or a high-fat meal
|
36 hours
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Katarina Borer, PhD, University of Michigan
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- R15DK082800-XFG
- R15DK082800 (U.S. NIH-bevilling/kontrakt)
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 .
Kliniske forsøg med Exercise and diets
-
Mondelēz International, Inc.KGK Science Inc.Afsluttet
-
Chinese University of Hong KongRekrutteringThoracale neoplasmerHong Kong
-
University of Alabama at BirminghamNational Multiple Sclerosis SocietyAfsluttetMultipel scleroseForenede Stater
-
Mondelēz International, Inc.KGK Science Inc.Afsluttet
-
Vastra Gotaland RegionGöteborg UniversityTilmelding efter invitation
-
Ondokuz Mayıs UniversityTilmelding efter invitationErnæringsvurdering | Ernæringsintervention | PCOS- Polycystisk ovariesyndromTyrkiet (Türkiye)
-
Biruni UniversityAfsluttet
-
Università degli Studi di BresciaAfsluttet
-
University of MichiganIkke rekrutterer endnuIrritabelt tarmsyndromForenede Stater