|- candidate number||23329|
|- NTR Number||NTR5523|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-okt-2015|
|- Secondary IDs||NL54634.081.15 |
|- Public Title||The effects of chewing and flavour intensity on satiation|
|- Scientific Title||The effects of mastication and oro-sensory exposure on satiation’|
|- ACRONYM||Gel-licious study|
|- hypothesis||When magnitude of the oro-sensory stimulation intensity and mastication are increased this will lead to an equal and additive reduction on food intake.|
|- Healt Condition(s) or Problem(s) studied||Overweight, Obesity, Food intake|
|- Inclusion criteria||-Good general health and appetite |
-Between 18-55 years old at the day of inclusion
-Fluent in Dutch and able to read and understand English (because of a questionnaire tool only available in English)
-BMI 18.5-27 kg/m2
-Men: no facial hair or willing to shave (due to facial markers video)
-Liking of the model food by scoring at least once (out of the two) a score 4 on a nine point hedonic scale, with not more than a 2 point score difference between the two textures*.
|- Exclusion criteria||-Dental pathologies such as known caries, full dentures or planning to undergo dental treatment during the study|
-Difficulties with swallowing and chewing
-Braces (not including a dental wire) or oral piercing
- Use of medication of which the taker notices (or has noticed in the past) that it influences appetite, taste, mastication and/or salivation or when the description of the medication describes effects on appetite, taste, mastication and or salivation.
-Allergies or intolerance to any ingredient of the model food of standardized pre-meal.
-Not willing to eat the model foods or standardized meal because of eating habits, (religious) believes or vegetarianism.
-Followed an energy restricted diet during the last 2 months
-Gained or lost 5 kg over the last half year
-Woman: not pregnant or planning to get pregnant within period of study or breastfeeding -High restrained eater according to the Dutch Eating Behaviour Questionnaire (men: score>2.9, women: score>3.4)*.
-Dislike for any of the textures according to the texture preference questionnaire (score of 1)*.
- Signed up for or 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||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||9-nov-2015|
|- planned closingdate||1-mrt-2016|
|- Target number of participants||65|
|- Interventions||chewing on either a soft or hard model food that is sweet or non sweet. |
|- Primary outcome||ad libitum intake in grams of each of the model foods|
|- Secondary outcome||number of chews and perceived sweetness|
|- Timepoints||not applicable|
|- Trial web site||https://voedingsonderzoek.wur.nl/gel-licious/|
|- 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 respective roles of both factors in their effect on satiation are unknown.|
The main objective of this study is to determine the independent and combined effects of mastication and orosensory stimulation intensity on satiation.
|- Main changes (audit trail)|
|- RECORD||28-okt-2015 - 15-jan-2016|