Dietary Modulation of Hepatic Lipase (LIPC) -514 C/T Variant Associations With Lipids and Glucose
|ClinicalTrials.gov Identifier: NCT02938091|
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : October 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Dyslipidemia Impaired Glucose Tolerance||Other: High-fat diet Other: Low-fat diet||Not Applicable|
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:
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
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
- change in fasting high-density lipoprotein cholesterol [ Time Frame: From date of randomization until completion of each 4 week dietary intervention ]
- change in fasting plasma triglycerides [ Time Frame: From date of randomization until completion of the 4 week dietary intervention ]
- change in fasting plasma glucose [ Time Frame: From date of randomization until completion of the 4 week dietary intervention ]
- oral glucose tolerance test [ Time Frame: 2 hours post-oral glucose load ]
- post-prandial lipemia 4 hours [ Time Frame: 4 hours post-oral fat load ]
- post-prandial lipemia 8 hours [ Time Frame: 8 hours post-oral fat load ]