Ignite Creation Date:
2024-05-06 @ 3:16 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02246543
Status:
COMPLETED
Last Update Posted:
2016-03-24
First Post:
2014-09-15
Brief Title:
Whey Protein Study - Identification of Sustainable Satiety
Sponsor:
University of Aberdeen
Organization:
University of Aberdeen
Study Overview
Official Title:
Whey Protein Study - Identification of Sustainable Satiety
Status:
COMPLETED
Status Verified Date:
2016-03
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:
This study will have the primary aim to investigate within-day changes in appetite after consumption of high-protein HP 30 of calories and normal or low protein LP 15 of calories whey protein meal in solid and liquid form on appetite and ad libitum food intake Secondary objective will be to assess the statistical relationship between plasma concentrations of gut hormones and visual analogue scales subjective hunger and fullness and transit time
In order to investigate the interaction of food structure and protein content on appetite this requires in practice either a differing amount g or calorie kJ load as a function of energy density defined as kJ100g Delivering the test meal as a solid and liquid form gives an easy solution to achieve this manipulation without compromising the nutritional profile Following on from this decision it is easier to produce different preloads using whey protein rather than meat protein since it is easily incorporated into test meals
In order to investigate the interaction of food structure and protein content on appetite this requires in practice either a differing amount g or calorie kJ load as a function of energy density defined as kJ100g Delivering the test meal as a solid and liquid form gives an easy solution to achieve this manipulation without compromising the nutritional profile Following on from this decision it is easier to produce different preloads using whey protein rather than meat protein since it is easily incorporated into test meals
Detailed Description:
A randomized crossover design in 10 overweightobese BMI 26-40 men and 10 lean men BMI 185-25 The control will be water Each subject will attend the HNU on six separate occasions The five test meal challenges will involve subjects attending the Human Nutrition Unit HNU in the morning after an overnight fast The total time of test meal visits will be approximately 4½hours They will be provided with a standardised meal after which blood samples will be collected for the first 2hrs The following five treatments will be tested
Treatment 1 Control - Water Egg Yolk Mixture 13C Octanoic Acid Treatment 2 HPL High Protein Liquid 30 protein 30 fat and 40 carbohydrate CHO Treatment 3 LPL Low Protein Liquid 15 protein 30 fat and 55 CHO Treatment 4 HPS High Protein Solid 30 protein 30 fat and 40 CHO Treatment 5 LPS Low Protein Solid 15 protein 30 fat and 55 CHO Test meals will be of fixed nutritional composition for all participants The liquid meal will be a milkfruit smoothie mixture and the solid will be in a milk jelly set form
Ad libitum pasta meal 15 protein 30 fat and 55 CHO as a homogenous mix and energy density of around 400kJ100g - served in excess as a individual 600g portion to help-yourself
Subjective average appetite will be measured every 30 min by visual analogue scales over 4hr and ad libitum food intake will measured 4hr after treatment consumption Ad libitum lunch will be a homogenous pasta meal with tomato sauce and a bottle of water Blood samples will be collected every 10 min for the first half hour every 15 min for the second half hour and every 30mins subsequently The breath gastric emptying measurement will be assessed using the 13Carbon 13C Octanoic Acid stable isotopic technique19 This involves mixing the tracer into food and taking breath samples and measured by isotope ratio mass spectrometry 13C Octanoic acid is a medium chain fatty acid which is rapidly absorbed in the duodenum and metabolised in the liver Following oxidation the resulting Carbon Dioxide CO2 is excreted into breath 12 samples will be collected during the 4hr test day
Treatment 1 Control - Water Egg Yolk Mixture 13C Octanoic Acid Treatment 2 HPL High Protein Liquid 30 protein 30 fat and 40 carbohydrate CHO Treatment 3 LPL Low Protein Liquid 15 protein 30 fat and 55 CHO Treatment 4 HPS High Protein Solid 30 protein 30 fat and 40 CHO Treatment 5 LPS Low Protein Solid 15 protein 30 fat and 55 CHO Test meals will be of fixed nutritional composition for all participants The liquid meal will be a milkfruit smoothie mixture and the solid will be in a milk jelly set form
Ad libitum pasta meal 15 protein 30 fat and 55 CHO as a homogenous mix and energy density of around 400kJ100g - served in excess as a individual 600g portion to help-yourself
Subjective average appetite will be measured every 30 min by visual analogue scales over 4hr and ad libitum food intake will measured 4hr after treatment consumption Ad libitum lunch will be a homogenous pasta meal with tomato sauce and a bottle of water Blood samples will be collected every 10 min for the first half hour every 15 min for the second half hour and every 30mins subsequently The breath gastric emptying measurement will be assessed using the 13Carbon 13C Octanoic Acid stable isotopic technique19 This involves mixing the tracer into food and taking breath samples and measured by isotope ratio mass spectrometry 13C Octanoic acid is a medium chain fatty acid which is rapidly absorbed in the duodenum and metabolised in the liver Following oxidation the resulting Carbon Dioxide CO2 is excreted into breath 12 samples will be collected during the 4hr test day
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 132033 | OTHER | Integrated Research Application System IRAS | None |