Ignite Creation Date:
2024-05-06 @ 12:57 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03898609
Status:
COMPLETED
Last Update Posted:
2021-07-29
First Post:
2019-03-25
Brief Title:
Effect of Low-Fat Compared to Low-Carbohydrate Diet in Subjects With Multifactorial Chylomicronemia
Sponsor:
Institut de Recherches Cliniques de Montreal
Organization:
Institut de Recherches Cliniques de Montreal
Study Overview
Official Title:
Effect of Low-Fat Compared to Low-Carbohydrate Diet on Fasting Lipids and Metabolic Profile in Subjects With Multifactorial Chylomicronemia A Randomized Crossover Study
Status:
COMPLETED
Status Verified Date:
2021-07
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:
MCMdiet
Brief Summary:
Introduction The multifactorial chylomicronemia MCM also known as type V hyperlipoproteinaemia or mixed hyperlipidaemia is an oligogenic or polygenic disorder that is associated with a reduction in lipoprotein lipase activity which leads to chylomicronemia In this disease very high concentrations of serum triglycerides 10 mmoll 880 mgdL can be observed in the fasting state due to the accumulation of both VLDL-C and chylomicron In patients with MCM chylomicronemia typically occur in adulthood and is exacerbated by the presence of secondary factors such as a diet rich in dietary fats and simple sugars obesity alcohol intake and uncontrolled diabetes It has been estimated that chylomicronemia can be found in 1600 adults However it is likely that the prevalence of MCM may increase in the future due to the increasing prevalence of obesity metabolic syndrome and type 2 diabetes This condition increases the risk of acute pancreatitis which can be recurrent and potentially fatal Indeed the risk of acute pancreatitis is 10-20 for TG levels 2258 mmolL 2000 mgdL Furthermore because MCM patients often present with other lipid disturbances as well as a worse metabolic profile these patients are at increased risk of cardiovascular disease CVD Fortunately MCM patients generally respond well to modifications in lifestyle to treatment of secondary factors and to triglycerides lowering therapies such as fibrates However it is still unknown which kind of diet has the greatest effect on triglycerides level and on the metabolic profile in MCM patients
The nutritional recommendations can be very different according to the nature of the patients population to be treated In order to reduce and manage triglycerides level in the general population the American Heart Association guidelines recommend reduction of simple carbohydrates intake
On the other hand the nutritional intervention strategy is quite different for subjects affected by familial chylomicronemia syndrome FCS for which the treatment focuses on restriction of dietary fat FCS is a very rare autosomal recessive disease that leads to a drastic reduction of chylomicrons clearance leading to chylomicronaemia Therefore a very strict lipid-controlled diet low in long-chain fatty acid 10-30gday or 10-15 of total energy intake is required in order to lower chylomicron formation
MCM is a complex condition in which both an increased VLDL formation by the liver and a decreased chylomicrons and VLDL clearance are present Furthermore triglycerides values are fluctuating from day to day but generally remain very high Therefore the best dietary approach for these patients remains to be elucidated
Primary Objective The primary objective of this study is to compare the effects of low-fat vs low-carbohydrate diets on fasting serum triglyceride concentrations
Secondary Objectives
1 To compare the effects of low-fat vs low-carbohydrate diets on other fasting cardiometabolic parameters measured LDL-C total cholesterol HDL-C glucose insulin HOMA-IR apoB non-HDL-C hs-CRP PCSK9 and free fatty acids FFA
2 To compare the effects of low-fat vs low-carbohydrate diets on SBP DBP and waist circumference
3 To compare the effects of low-fat vs low-carbohydrate diets on lipoprotein subfractions fasting
4 To compare the effects of low-fat vs low-carbohydrate meals on postprandial triglycerides insulin glucose FFA and PCSK9 after a standardized test meal
5 To assess the patients appreciation compliance and tolerability for each experimental diet feedback questionnaire
The nutritional recommendations can be very different according to the nature of the patients population to be treated In order to reduce and manage triglycerides level in the general population the American Heart Association guidelines recommend reduction of simple carbohydrates intake
On the other hand the nutritional intervention strategy is quite different for subjects affected by familial chylomicronemia syndrome FCS for which the treatment focuses on restriction of dietary fat FCS is a very rare autosomal recessive disease that leads to a drastic reduction of chylomicrons clearance leading to chylomicronaemia Therefore a very strict lipid-controlled diet low in long-chain fatty acid 10-30gday or 10-15 of total energy intake is required in order to lower chylomicron formation
MCM is a complex condition in which both an increased VLDL formation by the liver and a decreased chylomicrons and VLDL clearance are present Furthermore triglycerides values are fluctuating from day to day but generally remain very high Therefore the best dietary approach for these patients remains to be elucidated
Primary Objective The primary objective of this study is to compare the effects of low-fat vs low-carbohydrate diets on fasting serum triglyceride concentrations
Secondary Objectives
1 To compare the effects of low-fat vs low-carbohydrate diets on other fasting cardiometabolic parameters measured LDL-C total cholesterol HDL-C glucose insulin HOMA-IR apoB non-HDL-C hs-CRP PCSK9 and free fatty acids FFA
2 To compare the effects of low-fat vs low-carbohydrate diets on SBP DBP and waist circumference
3 To compare the effects of low-fat vs low-carbohydrate diets on lipoprotein subfractions fasting
4 To compare the effects of low-fat vs low-carbohydrate meals on postprandial triglycerides insulin glucose FFA and PCSK9 after a standardized test meal
5 To assess the patients appreciation compliance and tolerability for each experimental diet feedback questionnaire
Detailed Description:
None
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