Ignite Creation Date:
2024-05-06 @ 12:24 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01561235
Status:
COMPLETED
Last Update Posted:
2012-06-21
First Post:
2012-03-13
Brief Title:
Protein Dose-repsonse Effect on GLP-1 PYY and Appetite in Male Subjects
Sponsor:
University of Copenhagen
Organization:
University of Copenhagen
Study Overview
Official Title:
The Contribution of Gastrointestinal Appetite Hormones to Protein-induced
Status:
COMPLETED
Status Verified Date:
2012-06
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:
Protein
Brief Summary:
Dietary protein appears to be the most satiating and thermogenic macronutrient However how protein exerts its effect on appetite is not fully known The effect have been suggested to be related to a higher oxidation rate of protein compared to carbohydrate and fat and also to a greater thermogenic effect causing greater increase in core temperature The involvement of peripheral appetite-regulating hormones has only been sparingly investigated
The objective is to investigate the satiating effects of meals with varying content of meat-based protein and whether a dose-response effect can be found on appetite-regulating hormones and appetite ratings
Design 25 men will participate in the 3-way randomized double-blind crossover study The test meals is isocaloric with 30E fat and increasing protein content at the expense of carbohydrate Test meals are normal protein content NP 14E protein medium-high protein content MHP 25E and high protein contentHP 50E Four-hour subjective appetite ratings and blood samples will be assessed every half-hour Subsequently the subjects will served an ad libitum lunch
The objective is to investigate the satiating effects of meals with varying content of meat-based protein and whether a dose-response effect can be found on appetite-regulating hormones and appetite ratings
Design 25 men will participate in the 3-way randomized double-blind crossover study The test meals is isocaloric with 30E fat and increasing protein content at the expense of carbohydrate Test meals are normal protein content NP 14E protein medium-high protein content MHP 25E and high protein contentHP 50E Four-hour subjective appetite ratings and blood samples will be assessed every half-hour Subsequently the subjects will served an ad libitum lunch
Detailed Description:
Dietary protein appears to be the most satiating and thermogenic macronutrient 7-11 However how protein exerts its effect on appetite is not fully known The effect have been suggested to be related to a higher oxidation rate of protein compared to carbohydrate and fat 12 and also to a greater thermogenic effect causing greater increase in core temperature 13 The involvement of peripheral appetite-regulating hormones has only been sparingly investigated 14 These studies have only included two preloads of different concentrations of protein This is not an optimal design for investigating the protein dose-dependent effect as the threshold can have been reached in between the two concentrations The effect of protein has mainly been investigated on glucagon-like peptide-1 GLP-1 ghrelin cholecystokinin CCK and generally after intake of protein below 35 of the energy content 35E 515-18 The relationship between these appetite-regulating hormones and appetite is still elusive due to contradicting results Only one study has investigated the effect of protein preloads above 50E Bowen et al 19 found that the high protein preloads could decrease the concentration of CCK and the rate of gastric emptying which have been shown to enhance the satiating effect of food 20-22 Thus there is a need to examine the effect of protein on appetite-regulating hormones in a dose-response manner in order to detect whether there is an interaction between them and if they can be related to changes in subjective sensations of appetite and EI 14 This should be examined by comparing more than two isocaloric meals in which the protein content and one other macronutrient should vary whereas the third macronutrient should be kept fixed
Thus the objective of this study is to investigate the mechanisms responsible for the satiating effects of protein in three isocaloric test meals with a protein content of 14 25 or 50 E protein A possible dose-response effect of protein is investigated on a number of appetite-regulating hormonespeptides together with changes in ad libitum energy intake
Design 25 men will participate in the 3-way randomized double-blind crossover study The test meals is isocaloric with 30E fat and increasing protein content at the expense of carbohydrate Test meals are normal protein content NP 14E protein medium-high protein content MHP 25E and high protein contentHP 50E Four-hour subjective appetite ratings and blood samples will be assessed every half-hour Subsequently the subjects will served an ad libitum lunch
Thus the objective of this study is to investigate the mechanisms responsible for the satiating effects of protein in three isocaloric test meals with a protein content of 14 25 or 50 E protein A possible dose-response effect of protein is investigated on a number of appetite-regulating hormonespeptides together with changes in ad libitum energy intake
Design 25 men will participate in the 3-way randomized double-blind crossover study The test meals is isocaloric with 30E fat and increasing protein content at the expense of carbohydrate Test meals are normal protein content NP 14E protein medium-high protein content MHP 25E and high protein contentHP 50E Four-hour subjective appetite ratings and blood samples will be assessed every half-hour Subsequently the subjects will served an ad libitum lunch
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