|- candidate number||24393|
|- NTR Number||NTR5870|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-mei-2016|
|- Secondary IDs|| NL56824.081.16. |
|- Public Title||JellyHead|
|- Scientific Title||Effects of orosensory exposure manipulations on the cephalic phase repsonse|
|- hypothesis||Hormone responses increase (quicker) with greater oro-sensory exposure; i.e. with greater taste intensity (sweetness) and longer mastication duration. |
|- Healt Condition(s) or Problem(s) studied||Obesity|
|- Inclusion criteria||• Male|
• Between 18-35 years old at the day of inclusion
• Able to understand and speak Dutch or English fluently or without difficulty
• BMI 18.5-25 kg/m2
• Good general health and appetite (F1 questionnaire and judge by the subject)
• Eating three meals a day, every day around the same times. (self-report see F1 questionnaire).
|- Exclusion criteria||• Dental pathologies such as known caries, full dentures or planning to undergo dental treatment during the study|
• Difficulties with swallowing, chewing and or eating
• Suffering from an endocrine or eating disorder, gastrointestinal illness or illness of the thyroid gland or diabetes.
• Having taste or smell disorders (self-report)
• Braces (not including a dental wire) or oral piercing
• Consuming on average more than 28 glasses of alcohol per week
• Facial hair not willing to shave (due to facial markers video)
• Use of medication that may influence study outcomes ( see, F1 questionnaire)
• Allergies or intolerance to any ingredient of the model food or ad libitum lunch.
• Not willing to eat the model foods or ad libitum lunch because of eating habits, (religious) believes or vegetarianism.
• Followed an energy restricted diet during the last 2 months
• Gained or lost 5 kg of body weight over the last half year
• High restrained eater according to the Dutch Eating Behaviour Questionnaire (men: score>2.9)*.
• Signed up for participating in another research study (with the exception of the EetMeetWeet study).
• Employee of Human Nutrition (WUR)
• Thesis student or intern at the chair group of Sensory Science and Eating Behaviour Human Nutrition (WUR).
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||5-sep-2016|
|- planned closingdate||1-jan-2017|
|- Target number of participants||18|
|- Interventions||: Participants join five sessions during which they sham feed on model foods (x4) and 1 session during which they do not sham feed or eat the gels. The model foods or gels differ in chewing duration and sweetness. During sham feeding and during the control condition blood drawings are taken and subjects are recorded on video to determine the number of chews.|
|- Primary outcome||The main parameters of interest are responses of glucose , insulin, PP, ghrelin, CCK-8 and leptin. |
|- Secondary outcome||The secondary study parameter is intake in gram during an ad libitum lunch meal. |
|- Timepoints||not applicable |
|- Trial web site||http://www.wageningenur.nl/en/project/Satisfaction-parsing-satiation.htm|
|- CONTACT FOR PUBLIC QUERIES|| Marlou Lasschuijt|
|- CONTACT for SCIENTIFIC QUERIES|| Marlou Lasschuijt|
|- Sponsor/Initiator ||Wageningen University (WUR)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Mastication and orosensory exposure are closely related. However, the roles of both factors in their effect on the cephalic phase responses and satiation are unknown. |
|- Main changes (audit trail)|
|- RECORD||24-mei-2016 - 2-jul-2016|