Ignite Creation Date:
2024-05-06 @ 7:40 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02575131
Status:
COMPLETED
Last Update Posted:
2016-10-19
First Post:
2015-10-06
Brief Title:
Breakfast Test Products and Acute Satiety Scores
Sponsor:
TNO
Organization:
TNO
Study Overview
Official Title:
The Effect of Breakfast Test Products on Acute Satiety Scores in Different Test Conditions
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rationale The worldwide prevalence of obesity increases rapidly and at the moment there are more overweight than underweight people in the world This is partly caused by increased energy or food intake One of the physiological factors regulating the food intake pattern is satiety Though the regulation of food intake has been studied quite extensively the underlying mechanisms are not well elucidated yet and still new factors involved in this regulation are being found Therefore in this study the investigators aim to develop an in vitro screening tool combined with an in silico model for prediction of satiety for cost- and time - effective screening of satiating properties of new and existing complex food products and functional ingredients based on actual satiety scores measured A second aim of the Wholegrain Satiety project is to evaluate satiating properties of different types of wholegrain breads and other oat based products both for validation purposes and to strengthen the scientific evidence for health benefits of wholegrain products As part of this study acute satiety scores after consumption of various breakfast products in well-controlled clinical conditions will be compared with satiety scores obtained in at home test conditions
Objective The current study aims to compare the acute satiety effect of carbohydrate breakfast products
Objective The current study aims to compare the acute satiety effect of carbohydrate breakfast products
Detailed Description:
In the present study the investigators will conduct a clinical trial in which a standard protocol will be used to examine five different breakfasts different in type breakfast cereals and bread and macronutrient composition with satiating ingredients which will reveal actual human satiety scores The visual analogue scales used for determination of satiety feelings is an accepted method by EFSA and studied extensively It is used by TNO in an earlier carbohydrate containing breakfast experiment
Subjects may feel and eat differently at home Especially since supervision by a researcher is known to influence behavior of participants Self-measuring has the potential of giving more reliable estimates of intervention effects Therefore it is interesting to repeat the tests that are performed in the clinical unit in an at home condition because that is the place consumers eat their breakfast habitually ecological validity
Study design The study is designed as an open randomized controlled cross-over trial
Study population Forty healthy lean and overweight non-restrained eating women
Intervention The intervention consists of five different normal breakfasts normal amount about 243-355 kCal bread cooked oatmeal cereal meal fried egg with bread provided as a breakfast in the metabolic ward and at home
Main study parametersendpoints Satiety scores will be obtained with visual analogue rating scales VAS Subjects will rate hunger feelings fullness feelings satiety feelings desire to eat and rate their prospective food consumption before and multiple times after consumption of a breakfast A test session lasts for four hours t 0 15 30 45 60 90 120 150 180 210 and 240 minutes
In the controlled conditions at TNO finger pricks will be performed at t 0 30 60 90 and 120 minutes after breakfast consumption to measure blood glucose
Nature and extent of the burden and risks associated with participation benefit and group relatedness Subjects will consume prescribed standardized breakfast products five times at a clinical unit and five times at home No risk is associated with intake of the test products The VAS questionnaire will be filled in on the laptop multiple times on all test days at home and at the clinic No risk or real burden is of concern in this study Subjects will perform finger pricks five times in each controlled session at TNO what is known as a minimally invasive technique to obtain drops of blood
Subjects may feel and eat differently at home Especially since supervision by a researcher is known to influence behavior of participants Self-measuring has the potential of giving more reliable estimates of intervention effects Therefore it is interesting to repeat the tests that are performed in the clinical unit in an at home condition because that is the place consumers eat their breakfast habitually ecological validity
Study design The study is designed as an open randomized controlled cross-over trial
Study population Forty healthy lean and overweight non-restrained eating women
Intervention The intervention consists of five different normal breakfasts normal amount about 243-355 kCal bread cooked oatmeal cereal meal fried egg with bread provided as a breakfast in the metabolic ward and at home
Main study parametersendpoints Satiety scores will be obtained with visual analogue rating scales VAS Subjects will rate hunger feelings fullness feelings satiety feelings desire to eat and rate their prospective food consumption before and multiple times after consumption of a breakfast A test session lasts for four hours t 0 15 30 45 60 90 120 150 180 210 and 240 minutes
In the controlled conditions at TNO finger pricks will be performed at t 0 30 60 90 and 120 minutes after breakfast consumption to measure blood glucose
Nature and extent of the burden and risks associated with participation benefit and group relatedness Subjects will consume prescribed standardized breakfast products five times at a clinical unit and five times at home No risk is associated with intake of the test products The VAS questionnaire will be filled in on the laptop multiple times on all test days at home and at the clinic No risk or real burden is of concern in this study Subjects will perform finger pricks five times in each controlled session at TNO what is known as a minimally invasive technique to obtain drops of blood
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None