Multifactorial Chylomicronemia (MCM)MCMdietNCT03898609
Effect of Low-Fat Compared to Low-Carbohydrate Diet in Subjects With Multifactorial Chylomicronemia
A study testing Dietary intervention in people with Multifactorial Chylomicronemia (MCM), run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multifactorial Chylomicronemia (MCM)
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 21 Jan 2019to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women ≥ 18 years.
- Fasting triglycerides values ≥ 10 mmol/L (≥ 880 mg/dL) at least once, with or without medication.
- Fasting triglycerides values ≥ 6.0 mmol/L at screening.
Who cannot join
- A diagnosis of familial chylomicronemia syndrome, familial hypercholesterolemia or type III hyperlipidemia.
- An episode of accute pancreatitis in the 6 months prior the screening.
- Recent changes (in the last 3 months) in medication or supplement known to affect glucose metabolism such as steroid or oral contraceptive.
- Recent changes (in the last 4 weeks) in lipid-lowering medication such as fibrates and statins.
- Any condition known to affect lipid or glucose metabolism such as uncontrolled hypothyroidism or Cushing's syndrome.
- Major surgery in the 3 months preceding the study.
Show all 14Show fewer
- Significant weight change (±10 %) within 3 months prior to beginning the study.
- Inability to reduce alcohol use (0-2 units per week).
- The necessity or the wish to follow a specific diet.
- BMI ≥ 40 kg/m2.
- Breastfeeding woman.
- Pregnancy or the wish to become pregnant.
- Consumption of dietary supplements such as omega-3, psyllium or phytosterols.
- Any serious health condition associated with a life expectancy of ≤ 1 year.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut de recherches cliniques de Montreal
Montreal, Quebec, H2W1R7
About this study
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
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 mmol/l (≥880 mg/dL)) 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 1:600 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 > 22.58 mmol/L (>2000 mg/dL). 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 patient's 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.
Read more
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 (10-30g/day 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.
- 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).
- To compare the effects of low-fat vs low-carbohydrate diets on SBP, DBP and waist circumference.
- To compare the effects of low-fat vs low-carbohydrate diets on lipoprotein subfractions (fasting).
- To compare the effects of low-fat vs low-carbohydrate meals on postprandial triglycerides, insulin, glucose, FFA and PCSK9 after a standardized test meal.
- To assess the patients' appreciation, compliance and tolerability for each experimental diet (feedback questionnaire).
- Conditions
- Multifactorial Chylomicronemia (MCM)
- Being tested
- Dietary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionOther
3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Low-fat diet | Experimental | 20% fat 20% protein 60% carbohydrate Receives: Other: Dietary intervention |
| Low-carbohydrate diet | Experimental | 45% fat 20% protein 35% carbohydrate Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of triglycerides from baseline
Fasting serum triglyceride concentrations (mmol/L)
Measured: 3 weeks
Secondary outcomes (19)
Change of measured LDL-C from baseline
Fasting measured LDL-C concentrations (mmol/L)
Measured: 3 weeks
Change of total cholesterol from baseline
Fasting total cholesterol concentrations (mmol/L)
Measured: 3 weeks
Change of HDL-C from baseline
Fasting HDL-C concentrations (mmol/L)
Measured: 3 weeks
Change of glucose from baseline
Fasting glucose concentrations (mmol/L)
Measured: 3 weeks
Change of insulin from baseline
Fasting insulin concentrations (pmol/L)
Measured: 3 weeks
Change of apolipoprotein B from baseline
Fasting apolipoprotein B concentrations (g/L)
Measured: 3 weeks
Change of hs-CRP from baseline
Fasting hs-CRP concentrations (mg/L)
Measured: 3 weeks
Change of PCSK9 from baseline
Fasting PCSK9 concentrations (ng/mL)
Measured: 3 weeks
Change of free fatty acids from baseline
Fasting free fatty acids concentrations (mEq/L)
Measured: 3 weeks
Change of systolic blood pressure from baseline
Measurement of systolic blood pressure (mmHg)
Measured: 3 weeks
Change of diastolic blood pressure from baseline
Measurement of diastolic blood pressure (mmHg)
Measured: 3 weeks
Change of waist circumference from baseline
Measurement of waist circumference (cm)
Measured: 3 weeks
Change in the composition of lipoprotein fractions from baseline
Ultracentrifugation and lipoprotein electrophoresis
Measured: 3 weeks
Postprandial triglycerides
After a standardized test meal (1h, 2h, 4h and 6h) (mmol/L)
Measured: One day
Postprandial insulin
After a standardized test meal (1h, 2h, 4h and 6h) (pmol/L)
Measured: One day
Postprandial glucose
After a standardized test meal (1h, 2h, 4h and 6h) (mmol/L)
Measured: One day
Postprandial free fatty acids
After a standardized test meal (1h, 2h, 4h and 6h) (mEq/L)
Measured: One day
Postprandial PCSK9
After a standardized test meal (1h, 2h, 4h and 6h) (ng/mL)
Measured: One day
Questionnaire of appreciation, compliance and tolerability
The patients' appreciation, compliance and tolerability for each experimental diet will be collected in a questionnaire
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start21 Jan 2019
- Primary completion13 Mar 2020
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multifactorial Chylomicronemia (MCM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sophie Bernard, Institut de Recherches Cliniques de Montreal
- Investigators
- Sophie Bernard, MD, PhD, Principal investigator, Institut de Recherches Cliniques de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898609
- Sponsor's protocol ID
- 2019-957
- Acronym
- MCMdiet
- Status last verified
- Jul 2021
- First submitted
- 25 Mar 2019
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03898609
- Acronym / sponsor ID
- MCMdiet / 2019-957
- Conditions
- Multifactorial Chylomicronemia (MCM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 mmol/l (≥880 mg/dL)) 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 1:600 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 > 22.58 mmol/L (>2000 mg/dL). 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 patient's 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 (10-30g/day 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.
- 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).
- To compare the effects of low-fat vs low-carbohydrate diets on SBP, DBP and waist circumference.
- To compare the effects of low-fat vs low-carbohydrate diets on lipoprotein subfractions (fasting).
- To compare the effects of low-fat vs low-carbohydrate meals on postprandial triglycerides, insulin, glucose, FFA and PCSK9 after a standardized test meal.
- To assess the patients' appreciation, compliance and tolerability for each experimental diet (feedback questionnaire).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-fat diet | Experimental | Other: Dietary intervention20% fat 20% protein 60% carbohydrate |
| Low-carbohydrate diet | Experimental | Other: Dietary intervention45% fat 20% protein 35% carbohydrate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women ≥ 18 years.
- Fasting triglycerides values ≥ 10 mmol/L (≥ 880 mg/dL) at least once, with or without medication.
- Fasting triglycerides values ≥ 6.0 mmol/L at screening.
Key exclusion criteria (14 listed)
- A diagnosis of familial chylomicronemia syndrome, familial hypercholesterolemia or type III hyperlipidemia.
- An episode of accute pancreatitis in the 6 months prior the screening.
- Recent changes (in the last 3 months) in medication or supplement known to affect glucose metabolism such as steroid or oral contraceptive.
- Recent changes (in the last 4 weeks) in lipid-lowering medication such as fibrates and statins.
- Any condition known to affect lipid or glucose metabolism such as uncontrolled hypothyroidism or Cushing's syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary intervention3 weeks | Other | Low-carbohydrate diet, Low-fat diet |
Primary outcome
Change of triglycerides from baseline
Time frame: 3 weeks
Fasting serum triglyceride concentrations (mmol/L)
19 secondary outcomes
Change of measured LDL-C from baseline
Time frame: 3 weeks
Change of total cholesterol from baseline
Time frame: 3 weeks
Change of HDL-C from baseline
Time frame: 3 weeks
Change of glucose from baseline
Time frame: 3 weeks
Change of insulin from baseline
Time frame: 3 weeks
Change of apolipoprotein B from baseline
Time frame: 3 weeks
Change of hs-CRP from baseline
Time frame: 3 weeks
Change of PCSK9 from baseline
Time frame: 3 weeks
Change of free fatty acids from baseline
Time frame: 3 weeks
Change of systolic blood pressure from baseline
Time frame: 3 weeks
Change of diastolic blood pressure from baseline
Time frame: 3 weeks
Change of waist circumference from baseline
Time frame: 3 weeks
Change in the composition of lipoprotein fractions from baseline
Time frame: 3 weeks
Postprandial triglycerides
Time frame: One day
Postprandial insulin
Time frame: One day
Postprandial glucose
Time frame: One day
Postprandial free fatty acids
Time frame: One day
Postprandial PCSK9
Time frame: One day
Questionnaire of appreciation, compliance and tolerability
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Bernard, MD, PhD principal investigator
Institut de Recherches Cliniques de Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with Multifactorial Chylomicronemia (MCM), run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of triglycerides from baseline (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.