- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01064778
Glycemic Index and Brain Function
The Effects of Dietary Glycemic Index on Brain Function
Studieoversigt
Detaljeret beskrivelse
Most individuals have great difficulty following reduced calorie diets because they experience increased hunger. This process is regulated by specific brain areas. Though many psychological and environmental factors are involved, physiological effects of diet may have a significant impact. The postprandial rise in blood glucose, quantified by the glycemic index (GI), is of particular interest. High GI meals elicit hormonal events that limit availability of metabolic fuels, causing hunger and overeating, especially in people with high insulin secretion.
Our aim is to examine how postprandial changes after high versus low GI meals affect hunger and brain function in areas of intake control. Specifically, we speculate that obese individuals will demonstrate functional changes in brain areas of intake control and increased hunger after a high versus low GI meal.
We will recruit obese, young adults and quantify their insulin secretion during a 2-hour oral glucose tolerance test. A brief practice MRI session will serve to familiarize the subjects with the scanning process. During the two test sessions, standardized test meals with high versus low GI will be given in a randomized, blinded cross-over design. Serial blood levels of hormones, metabolic fuels, and metabolites will be correlated with perceived hunger, and a perfusion MRI scan will be performed to assess brain activation during the late postprandial phase, at the nadir of blood sugar and insulin levels (4 hours postprandial).
This work will inform an integrated physiological model relating peripheral postprandial changes to brain function and hunger. In addition, findings may provide evidence of a novel diet-phenotype, in which baseline clinical characteristics can be used to predict which weight loss diet will work best for a specific individual. Metabolite profiling might shed light on the mechanisms linking diet composition to brain function, and provide feasible clinical markers of the identified phenotype to facilitate translation into practice.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Forenede Stater, 02115
- Children's Hospital Boston
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Boston, Massachusetts, Forenede Stater, 02215
- Brigham and Women's Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion criteria
- Males age 18 to 35 years
- BMI less than or equal to 25 for age and gender
Exclusion criteria
- weight > 300 lbs
- largest body circumference > 144cm
- body shape incompatible with MRI scanner or equipment
- MRI exclusion criteria
- large fluctuations in body weight (5% over preceding 6 months, 2.5% during the study)
- known medical problems that may affect metabolism or hormones
- diabetes mellitus (fasting plasma glucose ≥126 mg/dL)
- other abnormal laboratory screening tests
- taking any medications or dietary supplements that might affect body weight, appetite, or energy expenditure
- smoking or illicit substance abuse
- high levels of physical activity (>30 minutes per day, > 4days per week)
- currently following a weight loss diet
- allergies or intolerance to eggs, vanilla extract, equal, canola oil, milk, cornstarch, corn syrup
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Low GI
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Subjects will be instructed to consume a liquid test meal with a low GI over 5 minutes after baseline laboratory evaluations.
The low and high GI meal contain similar amounts of milk, oil, dried egg whites, equal, and vanilla extract.
The low GI meal corn-starch as a carbohydrate.
Both meals have similar macronutrient composition (60% carbohydrate, 15% protein, 25% fat), micronutrient profiles, physical properties, palatability and sweetness.
The high vs. low GI meals have a predicted difference in GI of 90 vs. 40, and consistent with this prediction, a pilot study in obese young adults found a 2.2-fold difference in glycemic response (p<0.001).
The test meals will provide 25% of individual daily energy requirements.
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Eksperimentel: High GI
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Subjects will be instructed to consume a liquid test meal with a high GI over 5 minutes after baseline laboratory evaluations.
The low and high GI meal contain similar amounts of milk, oil, dried egg whites, equal, and vanilla extract.
The high GI meal contains corn-syrup as a carbohydrate.
Both meals have similar macronutrient composition (60% carbohydrate, 15% protein, 25% fat), micronutrient profiles, physical properties, palatability and sweetness.
The high vs. low GI meals have a predicted difference in GI of 90 vs. 40, and consistent with this prediction, a pilot study in obese young adults found a 2.2-fold difference in glycemic response (p<0.001).
The test meals will provide 25% of individual daily energy requirements.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Blood Flow in Brain Areas of Intake Control.
Tidsramme: 4 hours postprandial
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4 hours postprandial
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Subjective Hunger Rating
Tidsramme: Every 30 minutes for 5 hours.
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Every 30 minutes for 5 hours.
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Blood Glucose Level
Tidsramme: Every 30 minutes for 5 hours.
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Every 30 minutes for 5 hours.
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Blood Insulin Level
Tidsramme: Every 30 minutes for 5 hours
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Every 30 minutes for 5 hours
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Blood Glucagon Level
Tidsramme: Every 30 minutes for 5 hours.
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Every 30 minutes for 5 hours.
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Blood Growth Hormone Level
Tidsramme: Every 30 minutes for 5 hours.
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Every 30 minutes for 5 hours.
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Blood Epinephrine Level
Tidsramme: Every 30 minutes for 5 hours.
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Every 30 minutes for 5 hours.
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Blood Fatty Acids Level
Tidsramme: Every 30 minutes for 5 hours.
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measuring metabolite profiles
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Every 30 minutes for 5 hours.
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Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Belinda S Lennerz, MD, PhD, Boston Children's Hospital
- Ledende efterforsker: David Alsop, PhD, Beth Israel Deaconess Medical Center
Publikationer og nyttige links
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
- RA-003
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