Ignite Creation Date:
2024-05-06 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 12:46 PM
Study NCT ID:
NCT03531398
Status:
COMPLETED
Last Update Posted:
2020-02-18
First Post:
2018-04-24
Brief Title:
Postprandial Responses to Typical UK Meal Nutrient Profiles
Sponsor:
Kings College London
Organization:
Kings College London
Study Overview
Official Title:
Postprandial Responses to Typical UK Meal Nutrient Profiles
Status:
COMPLETED
Status Verified Date:
2018-04
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:
Pre-PREDICT
Brief Summary:
The aim of the current study is to investigate the postprandial metabolic response to typically consumed fat and carbohydrate doses in single meals An additional aim is to validate the use of dry blood spot DBS for triglyceride analysis versus venous blood sampling
Detailed Description:
Background Dietary fat consumption is one of the major modifiable risk factors implicated in the causation of cardiovascular disease CVD Postprandial lipaemia PPL the increase in circulating blood triacylglycerol TAG concentrations after a fat containing meal is an independent risk factor for cardiovascular disease However little is known about how different doses of fats as found in typical UK meals will influence the level of PPL
The majority of research into PPL including work by our own group and others has largely focused on the postprandial effect following high fat meals with the primary goal of assessing mechanisms underlying fat metabolism However these findings are not relevant from a public health perspective in reality the average fat content of a meal is much lower than this 20- 30 g fat NDNS 20134 therefore it is important to assess the impact of doses of fat in this range on PPL to be relevant to public health The few dose response studies that have been performed assessing fat load and PPL have used liquid test meals that are not relevant to every day meals
PPL is usually measured by taking a series of blood samples from a cannula however this is an invasive procedure There has been an increase in the development of less invasive biochemical assessment eg urine or saliva analysis or dried blood spot DBS analysis DBS analysis is particularly advantageous as samples can be easily collected by the individual under assessment with minimal equipment and transferred easily for analysis via the post providing simple home-testing Frequently postprandial research studies will draw blood from the cannula for multiple related outcomes and therefore performing multiple assays from one DBS sample would be advantageous in minimizing participant discomfort
Aim The primary aim of the current study is to investigate the postprandial response following typical UK meal nutrient profiles containing 20-30g fat Secondary aims will be to test the feasibility for measuring PPL insulin c-peptide and performing metabolomic analysis from DBS versus serum blood analysis Further it will assess the best practice for collection venous versus finger prick and storage ambient versus freezer of the DBS samples
Hypothesis Typical UK meal nutrient profiles will elicit detectable PPL Further DBS will be an effective method for measuring postprandial outcomes
Expected value The study will provide novel information on the effect of fat doses from typical UK meals on PPL It will also provide feasibility for using DBS for measuring postprandial responses
The majority of research into PPL including work by our own group and others has largely focused on the postprandial effect following high fat meals with the primary goal of assessing mechanisms underlying fat metabolism However these findings are not relevant from a public health perspective in reality the average fat content of a meal is much lower than this 20- 30 g fat NDNS 20134 therefore it is important to assess the impact of doses of fat in this range on PPL to be relevant to public health The few dose response studies that have been performed assessing fat load and PPL have used liquid test meals that are not relevant to every day meals
PPL is usually measured by taking a series of blood samples from a cannula however this is an invasive procedure There has been an increase in the development of less invasive biochemical assessment eg urine or saliva analysis or dried blood spot DBS analysis DBS analysis is particularly advantageous as samples can be easily collected by the individual under assessment with minimal equipment and transferred easily for analysis via the post providing simple home-testing Frequently postprandial research studies will draw blood from the cannula for multiple related outcomes and therefore performing multiple assays from one DBS sample would be advantageous in minimizing participant discomfort
Aim The primary aim of the current study is to investigate the postprandial response following typical UK meal nutrient profiles containing 20-30g fat Secondary aims will be to test the feasibility for measuring PPL insulin c-peptide and performing metabolomic analysis from DBS versus serum blood analysis Further it will assess the best practice for collection venous versus finger prick and storage ambient versus freezer of the DBS samples
Hypothesis Typical UK meal nutrient profiles will elicit detectable PPL Further DBS will be an effective method for measuring postprandial outcomes
Expected value The study will provide novel information on the effect of fat doses from typical UK meals on PPL It will also provide feasibility for using DBS for measuring postprandial responses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None