- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01891617
Exercise Effects on Insulin, Gut Peptides, and Appetite (XFG)
The Exercise Effects on Appetite and Gut Peptides While on High-fat Diet
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Michigan
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Ann Arbor, Michigan, Förenta staterna, 48109
- Michigan Clinical Research Unit
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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
|
Experimentell: 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
|
Experimentell: 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
|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Plasma insulin concentration
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Plasma concentrations of glucagon-like peptide-1 (GLP-1)
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Katarina Borer, PhD, University of Michigan
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- R15DK082800-XFG
- R15DK082800 (U.S.S. NIH-anslag/kontrakt)
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