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

NCT02938091 | Completed

• 1 other identifier: Study 2480
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Dyslipidemia; Impaired Glucose Tolerance

Keywords

Hispanics; Single nucleotide polymorphism; Hepatic lipase

Outcome Measures

Primary Outcomes (1)

• change in fasting high-density lipoprotein cholesterol

  From date of randomization until completion of each 4 week dietary intervention

Secondary Outcomes (5)

• change in fasting plasma triglycerides

  From date of randomization until completion of the 4 week dietary intervention

• change in fasting plasma glucose

  From date of randomization until completion of the 4 week dietary intervention

• oral glucose tolerance test

  2 hours post-oral glucose load

• post-prandial lipemia 4 hours

  4 hours post-oral fat load

• post-prandial lipemia 8 hours

  8 hours post-oral fat load

Study Arms (2)

High-fat diet

EXPERIMENTAL

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

Low-fat diet

EXPERIMENTAL

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

Interventions

High-fat diet OTHER

Typical Western diet

High-fat diet

Low-fat diet OTHER

Traditional Caribbean Hispanic diet

Low-fat diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-reported Caribbean Hispanics

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts University: lead

MeSH Terms

Conditions

Dyslipidemias; Glucose Intolerance

Interventions

Diet, High-Fat; Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperglycemia; Glucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Diet Therapy; Nutrition Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Nutrition and Genomics Laboratory

Study Record Dates

• First Submitted: October 16, 2016
• First Posted: October 19, 2016
• Study Start: January 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 19, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share