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Completed

NCT Number: NCT01806441

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

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.

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Key information

Conditions

Gene Expression

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Institute of nutrition and functional food

Québec, Quebec, G1V 0A6, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

3-days high fat diet

Other

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).

3-days low fat diet

Other

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).

Primary outcomes

  1. Change in duodenal mRNA expression of NPC1L1, ABCG5/8, MTP and FATP4.

    Time frame: At the end of the two 3-days diets (day 3 and day 17).

    Six biopsies (3 X 3 mm) will be obtained from the second portion of the duodenum during gastro-duodenoscopy. Biopsy specimen will be stored at -86°C before mRNA extraction. Total RNA will be isolated and used for polymerase chain reaction (PCR) quantification.

Secondary outcomes

  1. Change in surrogate markers of cholesterol absorption and synthesis.

    Time frame: At the end of the two 3-days diets (day 3 and day 17).

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

Impact of a Short-Term High Fat Diet Versus A Short-Term Low Fat Diet on Expression of the Key Intestinal Genes Involved in the Cholesterol and Fatty Acid Metabolism Pathways

Acronym: DGENES

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Mar 7, 2013
Registry last updated
Mar 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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