Pre-diabetesDGENE-NAFLDNCT05965973
Diet Impact on Hepatic Transcriptomics and Lipidomics in Pre-diabetes
A study testing Low fat diet and High fat diet in people with Pre-diabetes, run by Laval University at 1 site in Canada.
Trial summary
Non-alcoholic fatty liver disease (NAFLD) is one of the most common liver diseases, affecting 25% to 30% of the global population and nearly one third of the population in North America. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- Low fat diet and High fat diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 9 Jun 2023to 31 Jul 2026
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females 18 to 60 years of age.
- Non-smoker
- Waist circumference > 102 cm for men and > 88 cm for women.
- Plasma triglyceride levels > 1,7 mmol/L at the screening visit.
- Fasting plasma glucose levels > 6,1 mmol/L at the screening visit.
- Fasting plasma insulin levels above the upper limit of normal at the screening visit.
- Subjects must be willing to give written informed consent and able to adhere to the diet schedule and visit schedule.
- Patients should be otherwise healthy, without abnormal renal function or coagulation.
Who cannot join
- Patients with extreme dyslipidemias, such as familial hypercholesterolemia will be excluded.
- Subjects will be excluded if they have cardiovascular disease (CHD, cerebrovascular disease or peripheral arterial disease) or if they are taking other medications known to affect lipoprotein metabolism (eg. steroids, beta blockers, thiazide diuretics, other lipid lowering agents, significant alcohol intake etc.).
- Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
- Individuals with a history of mental instability, drug or alcohol abuse within the past 2 years or individuals who have been treated or are being treated for severe psychiatric illness that, in the opinion of the investigator, may interfere with optimal participation in the study.
- Disorders of the hematologic, digestive, or central nervous systems, including cerebrovascular disease and degenerative disease, that would limit study evaluation or participation.
- Known impairment of renal function (creatinine >2.0 mg/dL), dysproteinemia, nephrotic syndrome, or other renal disease.
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- Subjects with coagulopathy (prothrombin time [PT] or partial thromboplastin time [PTT] at Visit 1 higher than 1.5 times control).
- Patients who are known to have tested positive for human immunodeficiency virus (HIV).
- Patients who have used any investigational drug within 30 days of the first clinic visit.
- Diabetic patients are excluded from the study. Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins. Clinically euthyroid subjects on replacement doses of thyroid hormone are eligible for enrollment.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institute of Nutrition and Functional Foods (INAF)
Québec, Quebec, G1V 0A6
About this study
Official title: Short-term Impact of a Low Carbohydrate/High Unsaturated Fat Diet on Hepatic Transcriptomics and Lipidomics in Individuals With Pre-diabetes - A Pilot Study
Non-alcoholic fatty liver disease (NAFLD) is one of the most common liver diseases, affecting 25% to 30% of the global population and nearly one third of the population in North America. NAFLD is defined as an excessive accumulation of lipids within hepatocytes in the absence of significant alcohol consumption or other causes of chronic liver disease. These patients usually present with hepatic steatosis observed on imaging studies and elevated liver enzymes with clinical features of insulin resistance (IR), including pre-diabetes, type 2 diabetes mellitus (T2DM), arterial hypertension, dyslipidemia, and visceral obesity. The minimum criterion for a histologic diagnosis of NAFLD is >5 percent steatotic hepatocytes in a liver tissue section. The exact mechanism for the development of NAFLD is unclear, although the current evidence indicates that it is likely a complex interplay among neurohormones, intestinal dysbiosis, nutrition, and genetics. IR plays a crucial role in NAFLD pathophysiology mainly by increasing adipocyte lipolysis, resulting in the circulation of more free fatty acids available for hepatic uptake and increasing hepatic de novo lipogenesis. There is yet no approved pharmacologic option for the treatment of NAFLD. Current international guidelines on NAFLD emphasize the importance of lifestyle modifications for all patients with NAFLD and recommend 7-10% of weight loss and a "healthy diet", without suggesting any particular diet. Recent data provide some support for the beneficial role of low carbohydrate (CHO)/high unsaturated fatty acid (both monounsaturated (MUFAs) and polyunsaturated (PUFAs)) dietary patterns for decreasing hepatic steatosis. This proposal addresses this important research gap by leading to advances regarding the impact of a short-term low CHO/high PUFAs/MUFAs dietary intervention on improving hepatic gene expression profiles and lipid composition in individuals with pre-diabetes. The proposed study is unique because all meals and foods will be provided to participants under carefully controlled isocaloric conditions to maintain a constant bodyweight with optimal energy and macronutrient intake control. The primary objective of the proposed research is to investigate how replacement of dietary CHOs by unsaturated fatty acids (both PUFAs and MUFAs) affects liver fat composition and liver transcriptomics in subjects with pre-diabetes.
- Conditions
- Pre-diabetes
- Being tested
- Low fat diet, High fat diet
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low fat dietOther
During 3 days, subjects eat a diet low in fat (percent of total caloric intake: 15.0% from proteins; 65.0% from carbohydrates; 20.0% from fat: 4.0% from saturated fat; 10.0% from monounsaturated fat; 6.0% from polyunsaturated fat
High fat dietOther
During 3 days, subjects eat a diet high in fat (percent of total caloric intake: 15.0% from proteins; 45.0% from carbohydrates; 40.0% from fat: 8.0% from saturated fat; 22.0% from monounsaturated fat; 10.0% from polyunsaturated fat
| Study group | Role | What they receive |
|---|---|---|
| Low fat diet | Experimental | During 3 days, subjects eat a diet low in fat (percent of total caloric intake: 15.0% from proteins; 65.0% from carbohydrates; 20.0% from fat: 4.0% from saturated fat; 10.0% from monounsaturated fat; 6.0% from polyunsaturated fat Receives: Other: Low fat diet; Other: High fat diet |
| High fat diet | Experimental | During 3 days, subjects eat a diet high in fat (percent of total caloric intake: 15.0% from proteins; 45.0% from carbohydrates; 40.0% from fat: 8.0% from saturated fat; 22.0% from monounsaturated fat; 10.0% from polyunsaturated fat Receives: Other: Low fat diet; Other: High fat diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the expression of key genes in lipid metabolism including LDL-receptor, acetyl-CoA acetyltransferase 2, apolipoprotein B, proproprotein convertase subtilisin/kexin type 9, microsomal triglyceride transfer protein
Measured: At Day 3 and day 20 (at the end of the two 3-day diets)
Change in the expression of key genes in liver inflammation including C-reactive protein, Interleukin-6, Interleukin-15, cell adhesion molecules, E-selectin
Measured: At Day 3 and day 20 (at the end of the two 3-day diets)
Change in the expression of key genes in hepatic fibrogenesis including transforming growth factor beta 1, a-smooth muscle actin, type-1 collagen, connective tissue growth factor
Measured: At Day 3 and day 20 (at the end of the two 3-day diets)
Secondary outcomes (2)
Change in liver's key lipid pathways (lipidomics) including lysophosphatidylcholine, phosphatidylcholine, diglyceride.
Measured: At Day 3 and day 20 (at the end of the two 3-day diets)
Identify bacteria strains involved in the control of blood glucose such as C elegans.
Measured: At Day 3 and day 20 (at the end of the two 3-day diets)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start9 Jun 2023
- Primary completion31 Dec 2025
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Couture, Laval University
- Investigators
- Patrick Couture, MD, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965973
- Sponsor's protocol ID
- INAF 2023-6814
- Acronym
- DGENE-NAFLD
- Status last verified
- Aug 2026
- First submitted
- 12 Jun 2023
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Impact of a Low Carbohydrate/High Unsaturated Fat Diet on Hepatic Transcriptomics and Lipidomics in Individuals With Pre-diabetes - A Pilot Study
- ClinicalTrials.gov ID
- NCT05965973
- Acronym / sponsor ID
- DGENE-NAFLD / INAF 2023-6814
- Conditions
- Pre-diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 28 Jul 2023 (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.
Non-alcoholic fatty liver disease (NAFLD) is one of the most common liver diseases, affecting 25% to 30% of the global population and nearly one third of the population in North America. NAFLD is defined as an excessive accumulation of lipids within hepatocytes in the absence of significant alcohol consumption or other causes of chronic liver disease. These patients usually present with hepatic steatosis observed on imaging studies and elevated liver enzymes with clinical features of insulin resistance (IR), including pre-diabetes, type 2 diabetes mellitus (T2DM), arterial hypertension, dyslipidemia, and visceral obesity. The minimum criterion for a histologic diagnosis of NAFLD is >5 percent steatotic hepatocytes in a liver tissue section. The exact mechanism for the development of NAFLD is unclear, although the current evidence indicates that it is likely a complex interplay among neurohormones, intestinal dysbiosis, nutrition, and genetics. IR plays a crucial role in NAFLD pathophysiology mainly by increasing adipocyte lipolysis, resulting in the circulation of more free fatty acids available for hepatic uptake and increasing hepatic de novo lipogenesis. There is yet no approved pharmacologic option for the treatment of NAFLD. Current international guidelines on NAFLD emphasize the importance of lifestyle modifications for all patients with NAFLD and recommend 7-10% of weight loss and a "healthy diet", without suggesting any particular diet. Recent data provide some support for the beneficial role of low carbohydrate (CHO)/high unsaturated fatty acid (both monounsaturated (MUFAs) and polyunsaturated (PUFAs)) dietary patterns for decreasing hepatic steatosis. This proposal addresses this important research gap by leading to advances regarding the impact of a short-term low CHO/high PUFAs/MUFAs dietary intervention on improving hepatic gene expression profiles and lipid composition in individuals with pre-diabetes. The proposed study is unique because all meals and foods will be provided to participants under carefully controlled isocaloric conditions to maintain a constant bodyweight with optimal energy and macronutrient intake control. The primary objective of the proposed research is to investigate how replacement of dietary CHOs by unsaturated fatty acids (both PUFAs and MUFAs) affects liver fat composition and liver transcriptomics in subjects with pre-diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low fat diet | Experimental | Other: Low fat diet, Other: High fat dietDuring 3 days, subjects eat a diet low in fat (percent of total caloric intake: 15.0% from proteins; 65.0% from carbohydrates; 20.0% from fat: 4.0% from saturated fat; 10.0% from monounsaturated fat; 6.0% from polyunsaturated fat |
| High fat diet | Experimental | Other: Low fat diet, Other: High fat dietDuring 3 days, subjects eat a diet high in fat (percent of total caloric intake: 15.0% from proteins; 45.0% from carbohydrates; 40.0% from fat: 8.0% from saturated fat; 22.0% from monounsaturated fat; 10.0% from polyunsaturated fat |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Males and females 18 to 60 years of age.
- Non-smoker
- Waist circumference > 102 cm for men and > 88 cm for women.
- Plasma triglyceride levels > 1,7 mmol/L at the screening visit.
- Fasting plasma glucose levels > 6,1 mmol/L at the screening visit.
Key exclusion criteria (10 listed)
- Patients with extreme dyslipidemias, such as familial hypercholesterolemia will be excluded.
- Subjects will be excluded if they have cardiovascular disease (CHD, cerebrovascular disease or peripheral arterial disease) or if they are taking other medications known to affect lipoprotein metabolism (eg. steroids, beta blockers, thiazide diuretics, other lipid lowering agents, significant alcohol intake etc.).
- Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
- Individuals with a history of mental instability, drug or alcohol abuse within the past 2 years or individuals who have been treated or are being treated for severe psychiatric illness that, in the opinion of the investigator, may interfere with optimal participation in the study.
- Disorders of the hematologic, digestive, or central nervous systems, including cerebrovascular disease and degenerative disease, that would limit study evaluation or participation.
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 |
|---|---|---|
| Low fat dietDuring 3 days, subjects eat a diet low in fat (percent of total caloric intake: 15.0% from proteins; 65.0% from carbohydrates; 20.0% from fat: 4.0% from saturated fat; 10.0% from monounsaturated fat; 6.0% from polyunsaturated fat | Other | High fat diet, Low fat diet |
| High fat dietDuring 3 days, subjects eat a diet high in fat (percent of total caloric intake: 15.0% from proteins; 45.0% from carbohydrates; 40.0% from fat: 8.0% from saturated fat; 22.0% from monounsaturated fat; 10.0% from polyunsaturated fat | Other | High fat diet, Low fat diet |
Primary outcome
Change in the expression of key genes in lipid metabolism including LDL-receptor, acetyl-CoA acetyltransferase 2, apolipoprotein B, proproprotein convertase subtilisin/kexin type 9, microsomal triglyceride transfer protein
Time frame: At Day 3 and day 20 (at the end of the two 3-day diets)
Change in the expression of key genes in liver inflammation including C-reactive protein, Interleukin-6, Interleukin-15, cell adhesion molecules, E-selectin
Time frame: At Day 3 and day 20 (at the end of the two 3-day diets)
Change in the expression of key genes in hepatic fibrogenesis including transforming growth factor beta 1, a-smooth muscle actin, type-1 collagen, connective tissue growth factor
Time frame: At Day 3 and day 20 (at the end of the two 3-day diets)
2 secondary outcomes
Change in liver's key lipid pathways (lipidomics) including lysophosphatidylcholine, phosphatidylcholine, diglyceride.
Time frame: At Day 3 and day 20 (at the end of the two 3-day diets)
Identify bacteria strains involved in the control of blood glucose such as C elegans.
Time frame: At Day 3 and day 20 (at the end of the two 3-day diets)
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 26 Aug 2026.
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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.
Patrick Couture, MD, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low fat diet and High fat diet in people with Pre-diabetes, run by Laval University 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 8 inclusion and 10 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 26 Aug 2026. 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 in the expression of key genes in lipid metabolism including LDL-receptor, acetyl-CoA acetyltransferase 2, apolipoprotein B, proproprotein convertase subtilisin/kexin type 9, microsomal triglyceride transfer protein (time frame: At Day 3 and day 20 (at the end of the two 3-day diets)). The study lists 3 primary outcomes in all. 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 26 Aug 2026.