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Impact of a Short-Term High Fat or Low Fat Diet on Intestinal Genes Expression Involved in the Cholesterol and Fatty Acid Metabolism (DGENES)

L

Laval University

Status

Completed

Conditions

Gene Expression

Treatments

Other: 3-days low fat diet
Other: 3-days high fat diet

Study type

Interventional

Funder types

Other

Identifiers

NCT01806441
INAF-125-05-06

Details and patient eligibility

About

Dietary fat has been shown to modulate cholesterol and fatty acids homeostasis and several lines of evidence suggest that this effect is associated with changes in the regulation of different genes at the intestine level involved in the cholesterol and fatty acid metabolism pathways. The present study will examine the impact of a short-term high fat diet versus a short-term low fat diet on expression of Niemann-Pick C1-like 1 (NPC1L1), adenosine triphosphate (ATP) binding cassette transporters (ABCG5/8), microsomal triglyceride transfer protein (MTP) and fatty acid transport protein-4 (FATP4), which have been shown to play a critical role in intestinal cholesterol absorption, chylomicron synthesis and dietary lipid absorption. Gene expression studies will be performed on duodenal biopsies. The primary hypothesis is that a short-term high fat diet will significantly decrease duodenal messenger ribonucleic acid (mRNA) levels of NPC1L1, ABCG5/8, MTP and FATP4 as compared with a short-term low fat diet.

Enrollment

12 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Males 18 to 50 years of age
  • Non-smoker
  • Body mass index between 20.0 and 30.0 kg/m2
  • Plasma LDL-cholesterol levels between the 25th and 75th percentile for their age at day -14
  • Plasma triglyceride levels < 1.7 mmol/L (150 mg/dl) at day -14
  • Plasma HDL-cholesterol levels between 0.9 (35 mg/dl) and 1.6 mmol/L (60 mg/dl) at day -14
  • 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 elevations in hepatic transaminases or creatine kinase (CK) or abnormal renal function or coagulation

Exclusion criteria

  • 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.)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

12 participants in 2 patient groups

3-days high fat diet
Experimental group
Description:
During 3 days, subjects eat a diet high in fat (percent of total caloric intake: 15.0% from proteins; 49,8% from carbohydrates; 37.0% from fat).
Treatment:
Other: 3-days high fat diet
3-days low fat diet
Active Comparator group
Description:
During 3 days, subjects eat a diet low in fat (percent of caloric intake: 15.0% from proteins; 61,8% from carbohydrates; 25.0% from fats).
Treatment:
Other: 3-days low fat diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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