- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01891617
Exercise Effects on Insulin, Gut Peptides, and Appetite (XFG)
The Exercise Effects on Appetite and Gut Peptides While on High-fat Diet
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Michigan
-
Ann Arbor, Michigan, Verenigde Staten, 48109
- Michigan Clinical Research Unit
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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
|
Experimenteel: 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
|
Experimenteel: 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
|
Experimenteel: 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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Plasma insulin concentration
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Plasma concentrations of glucagon-like peptide-1 (GLP-1)
Tijdsspanne: 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)
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Katarina Borer, PhD, University of Michigan
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- R15DK082800-XFG
- R15DK082800 (Subsidie/contract van de Amerikaanse NIH)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Exercise and diets
-
Mondelēz International, Inc.KGK Science Inc.Voltooid
-
University of Texas at AustinLone Star Circle of CareVoltooidMetaboolsyndroom | Type 2 diabetes | Pre-diabetesVerenigde Staten
-
Wolfson Medical CenterBeëindigdColitis ulcerosaIsraël, Frankrijk, Italië
-
University of CalgaryStewart Diabetes Education FundVoltooidObesitas | Diabetes mellitus type 2Canada
-
Cairo UniversityWervingObesitas | Prikkelbare Darm Syndroom | Abdominale obesitasEgypte
-
University of LincolnNottinghamshire Healthcare NHS TrustWerving
-
Fondazione Valter LongoUniversity of Palermo; University of Calabria; Regione Calabria / Comune Varapodio en andere medewerkersWervingRisicogedrag | Obesitas | OvergewichtItalië
-
University of HertfordshireVoltooidHartinfarct | Multiple sclerose | Hersenletsel | Ziekte van ParkinsonVerenigd Koninkrijk
-
Dalarna UniversityUppsala University; The Swedish Research CouncilWervingDementie | Milde cognitieve stoornis | Dementie, gemengd | Dementie van het Alzheimer-type | Subjectieve cognitieve stoornissen | Dementie SenielZweden
-
GlaxoSmithKlineVoltooidTetanus | Difterie | Acellulaire kinkhoestVerenigde Staten