Ignite Creation Date:
2024-05-06 @ 9:14 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02931630
Status:
COMPLETED
Last Update Posted:
2017-07-17
First Post:
2016-08-19
Brief Title:
The Effect of Whey Protein and Dietary Fibers on Risk Markers of the Metabolic Syndrome and Bone Health
Sponsor:
Aarhus University Hospital
Organization:
Aarhus University Hospital
Study Overview
Official Title:
The Effect of Whey Protein and Dietary Fibers on Risk Markers of the Metabolic Syndrome and Bone Health
Status:
COMPLETED
Status Verified Date:
2017-07
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:
MERITS
Brief Summary:
The prevalence of overweight and lifestyle related diseases such as cardiovascular disease CVD and type 2 diabetes T2D is increasing world wide The metabolic syndrome MeS is a condition characterized by abdominal obesity high blood lipids high blood pressure and elevated blood sugar MeS is associated with an increased risk of developing CVD and T2D Dietary fibers and whey protein have independently shown beneficial effects on several of these risk factors in previous studies Whey protein is furthermore seen to show positive effects on bone turnover
The purpose of this trial is to investigate whether an increased intake of dietary fibers and whey protein separately or combined over a period of 12 weeks will affect the risk markers of MeS and bone turnover in abdominally obese subjects
A total of 80 people with abdominal obesity will be included The design is a randomized double blinded controlled dietary intervention trial Subjects are assigned to one of four experimental groups Each group are provided with test products containing either high or low whey protein and high or low dietary fibers to replace part of their regular diet The subjects are instructed in how to incorporate the test products in their habitual diets in order to maintain weight stability
The primary outcome is postprandial lipaemia PPL - an independent risk factor of developing CVD PPL is estimated by performing a standardized high fat meal test during which postprandial level of triglycerides is measured The authors hypothesize that a diet of high content of whey protein and high dietary fiber during 12 weeks will induce a reduction in PPL
The purpose of this trial is to investigate whether an increased intake of dietary fibers and whey protein separately or combined over a period of 12 weeks will affect the risk markers of MeS and bone turnover in abdominally obese subjects
A total of 80 people with abdominal obesity will be included The design is a randomized double blinded controlled dietary intervention trial Subjects are assigned to one of four experimental groups Each group are provided with test products containing either high or low whey protein and high or low dietary fibers to replace part of their regular diet The subjects are instructed in how to incorporate the test products in their habitual diets in order to maintain weight stability
The primary outcome is postprandial lipaemia PPL - an independent risk factor of developing CVD PPL is estimated by performing a standardized high fat meal test during which postprandial level of triglycerides is measured The authors hypothesize that a diet of high content of whey protein and high dietary fiber during 12 weeks will induce a reduction in PPL
Detailed Description:
Please refer to summary
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