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

Dyslipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02938091
• Other study ID #: Study 2480
• Status: Completed
• Phase: N/A
• First received: October 16, 2016
• Last updated: October 17, 2016
• Start date: January 2008
• Est. completion date: July 2012

Study information

• Verified date: October 2016
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Glucose Intolerance
• Impaired Glucose Tolerance

Intervention

Other:
• High-fat diet
Typical Western diet
• Low-fat diet
Traditional Caribbean Hispanic diet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in fasting high-density lipoprotein cholesterol		From date of randomization until completion of each 4 week dietary intervention	No
Secondary	change in fasting plasma triglycerides		From date of randomization until completion of the 4 week dietary intervention	No
Secondary	change in fasting plasma glucose		From date of randomization until completion of the 4 week dietary intervention	No
Secondary	oral glucose tolerance test		2 hours post-oral glucose load	No
Secondary	post-prandial lipemia 4 hours		4 hours post-oral fat load	No
Secondary	post-prandial lipemia 8 hours		8 hours post-oral fat load	No