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Dietary Modulation of Hepatic Lipase (LIPC) -514 C/T Variant Associations With Lipids and Glucose

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ClinicalTrials.gov Identifier: NCT02938091
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):
Jose Ordovas, Tufts University

Brief Summary:
The investigators evaluated dietary modulation of LIPC rs1800588 (-514 C/T) for lipids and glucose using a randomized cross-over design comparing a high-fat Western diet and a low-fat traditional Hispanic diet in Caribbean Hispanics (n=42; 4 weeks/phase).

Condition or disease Intervention/treatment Phase
Dyslipidemia Impaired Glucose Tolerance Other: High-fat diet Other: Low-fat diet Not Applicable

Detailed Description:

The LIPC -514 C/T single nucleotide polymorphism (SNP) has been inconsistently associated with high density lipoprotein cholesterol (HDL-C) in population studies, supporting the possibility of its modulation by dietary factors. To investigate the interaction between the common LIPC -514(C/T) SNP and dietary fat, the investigators compared changes in lipids and glucose in response to two levels of dietary total fat (20% energy intake vs. 39% energy intake) in a crossover, randomized dietary intervention study enrolling Caribbean Hispanics. Individuals were screened for LIPC rs1800588 genotype prior to enrollment, and genotype-associated differences in response to diet were evaluated.

The study was designed to test the following hypotheses:

  1. Carriers of the T allele consuming a low fat (LF) diet will have decreased hepatic lipase activity as compared with subjects with the CC genotype at the -514(C/T) polymorphism. Conversely, in individuals consuming a high fat (HF) diet, T carriers will exhibit an impaired ability to down regulate hepatic lipase activity.
  2. Based on differences in hepatic lipase activity, the investigators hypothesized that a significant and clinically relevant proportion of the individual variability in fasting plasma HDL-C responses to changes in dietary fat intake would be due to variability at the LIPC locus. Specifically, CC subjects will respond to increases in total dietary fat consumption with significant increases in HDL-C concentration. Conversely, increased fat consumption in T carrying subjects will result in decreased HDL-C concentration.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Hepatic Lipase Variant -514 C/T in a High Fat vs. Low Fat Diet for Cardio-metabolic Outcomes: A Crossover Randomized Dietary Intervention Trial
Study Start Date : January 2008
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Arm Intervention/treatment
Experimental: High-fat diet
The dietary intervention was designed as a typical Western diet (39% total fat, 14% saturated fat, 12% monounsaturated fat, 9.6% polyunsaturated fat, 42% carbohydrate, 8.8 grams fiber/1000 kcal)
Other: High-fat diet
Typical Western diet

Experimental: Low-fat diet
The dietary intervention consisted of a Hispanic diet (20% total fat, 5.5% saturated fat, 9.6% monounsaturated fat, 3.7% polyunsaturated fat, 61% carbohydrate, 13.7 grams fiber/1000 kcal). The diet was comprised of typical foods and recipes resembling a traditional Caribbean Hispanic diet and differed from the Western diet in four primary ways: 1) more fruits and vegetables, 2) more beans (e.g. mixed dishes to reduce serving size of white rice while increasing legumes), 3) emphasis on reduced-fat dairy products (e.g., 1% fat milk), and 4) lower total fat and lower animal and hydrogenated fat.
Other: Low-fat diet
Traditional Caribbean Hispanic diet




Primary Outcome Measures :
  1. change in fasting high-density lipoprotein cholesterol [ Time Frame: From date of randomization until completion of each 4 week dietary intervention ]

Secondary Outcome Measures :
  1. change in fasting plasma triglycerides [ Time Frame: From date of randomization until completion of the 4 week dietary intervention ]
  2. change in fasting plasma glucose [ Time Frame: From date of randomization until completion of the 4 week dietary intervention ]
  3. oral glucose tolerance test [ Time Frame: 2 hours post-oral glucose load ]
  4. post-prandial lipemia 4 hours [ Time Frame: 4 hours post-oral fat load ]
  5. post-prandial lipemia 8 hours [ Time Frame: 8 hours post-oral fat load ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Self-reported Caribbean Hispanics

Exclusion Criteria:

  • diabetes
  • uncontrolled hypertension
  • self-reported liver disease; severe kidney dysfunction; angina; endocrine disease; preexisting cardiovascular disease or gallbladder disease, or pancreatitis within the past 12 months
  • use of lipid-lowering or hypoglycemic medications
  • BMI >34 kg/m2
  • alcohol consumption (>2 drinks/day)
  • smoking within the past 6 months or illegal drug use
  • pregnancy or breastfeeding
  • weight gain or loss of more than 9 kg within the past 6 months
  • extreme levels of physical or athletic activity, strict vegetarians/vegans
  • egg, wheat, milk, fish, or nut allergies
  • unwillingness to discontinue fish oil or flaxseed supplements or drinking alcohol during the study
  • travel plans precluding availability for the two 4-week study phases

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Responsible Party: Jose Ordovas, Director, Nutrition and Genomics Laboratory, Tufts University
ClinicalTrials.gov Identifier: NCT02938091     History of Changes
Other Study ID Numbers: Study 2480
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jose Ordovas, Tufts University:
Hispanics
Single nucleotide polymorphism
Hepatic lipase

Additional relevant MeSH terms:
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Dyslipidemias
Glucose Intolerance
Lipid Metabolism Disorders
Metabolic Diseases
Hyperglycemia
Glucose Metabolism Disorders