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van CCT (UK)

van CCT (UK)

Yale Study

- candidate number27528
- NTR NumberNTR6583
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-jul-2017
- Secondary IDsMETC-nr 16/31 METC WUR
- Public TitleYale Study
- Scientific TitleGastric emptying, regional cerebral blood flow & metabolic rate under (mis)matched sweetness and calories in beverages
- hypothesisthe correspondence between orosensation of sweetness and post-oral sensation of calories influences resting energy expenditure, cerebral blood flow and gastric emptying, and more specifically that the “not sweet enough” beverage, that contains more calories than expected based on the sweetness, leads to a decreased REE, regional CBF in the food reward network and rate of GE compared to the isocaloric “appropriately sweet” beverage.
- Healt Condition(s) or Problem(s) studiedRegular physiology
- Inclusion criteria• Right handed
• Age 18 – 35yr
• BMI 18.5 - 25 kg/m2
• Being healthy (self-reported)
• Having given written informed consent (see E2)
- Exclusion criteria• Drug use or medical conditions which may interfere with normal functioning of the digestive tract
• Drug use or medical conditions which may interfere with normal functioning of the circulatory system
• Drug use or medical conditions which may lead to unreliable fMRI results (including, but not limited to neurological conditions)
• Food allergy to or unwillingness to consume maltodextrin, sucralose of food flavourings
• Reported unexplained weight loss or weight gain of > 5 kg in the month prior to pre-study screening
• Personnel of Wageningen University, department of Human Nutrition
• Current participation in other research from the Division of Human Nutrition
Please see form F1 for full exclusion questionnaire
• Having a contra-indication to MRI scanning (including, but not limited to):
 Pacemakers and defibrillators
 Intraorbital or intraocular metallic fragments
 Ferromagnetic implants
 Claustrofobia
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingTriple
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2017
- planned closingdate31-okt-2017
- Target number of participants15
- Interventionssucralose sweetened beverages containing maltodextrin
- Primary outcomeTreatment induced changes from baseline:
• Change in resting energy expenditure in kcal/day
• Change in gastric emptying rate in mm3/min
• Change in cerebral blood flow in mL/100 g·min
- Secondary outcomeInternal state (appetite) ratings before and after treatment Pleasantness ratings of beverages after treatment
- Timepointsbaseline and 0 - 35 minutes of data collection
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Wageningen University (WUR)
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryThe aim of this study is to test the hypothesis that orosensation influences carbohydrate metabolism (as measured by resting energy expenditure (REE)) and regional cerebral blood flow (CBF) by regulating gastric emptying (GE). Preliminary data from another laboratory show that when the sweetness of a flavored beverage is too strong or too weak for a given carbohydrate load (i.e. "mismatched"), REE and GE are decreased compared to isocaloric beverages where sweetness and calories are appropriately "matched".
The objective of the study is to test the hypothesis that the correspondence between orosensation of sweetness and postoral sensation of calories influences REE, CBF and GE.
The study design is a 2x2 factorial within participants double blind design, with the factors sweetness and calories (sweet and high caloric, low sweet and low caloric, sweet and low caloric (mismatched), and low sweet and high caloric (mismatched))
The study population consists of 15 healthy, normal weight (BMI 18.525 kg/m2), volunteers, between the age of 18 and 35y. Calories are manipulated with nonsweet polymer maltodextrin content at two levels: 75 and 150 kcal. Sweetness is
manipulated with sucralose at 2 levels: equivalent to sweetness of a 75 kcal or 150 kcal beverage sweetened with sucrose. This yields four combinations. The drinks also have a commercial flavoring. Primary study parameters/outcome of the study:
1. Change in resting energy expenditure in kcal/day
2. Change in gastric emptying rate in mm3/min
3. Change in cerebral blood flow in mL/100 g·min
- Main changes (audit trail)
- RECORD10-jul-2017 - 6-aug-2017

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