Status:
COMPLETED
Dietary Fat and High-Density Lipoprotein (HDL) Metabolism-Effect of Carbohydrate and Fat Intake
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Overweight
Cardiovascular Diseases
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
Generally, people with low levels of high-density lipoprotein (HDL) in blood are more likely to get heart disease than those who have normal or high levels. Dietary fat, whether the harmful type (satu...
Detailed Description
The investigators will study the kinetics of multiple types of high-density lipoprotein (HDL) in humans under two strictly controlled dietary conditions, high unsaturated fat and high carbohydrate, in...
Eligibility Criteria
Inclusion
- Only accepting participants in the Boston, Massachusetts area
- Age 21 to 75, male or female
- Willingness to eat prescribed diet for 4 weeks prior to infusion date, and 3.5 days after the infusion date
- Willingness to participate in an infusion protocol, which will require them to stay at the Center for Clinical Investigation (CCI) for one night and return for blood draws every day for the next 3 days.
- Body Mass Index (BMI) 25-35 Kg/m2
- HDL\<45 mg/dL for men, \<55 mg/dL for women
Exclusion
- Hematocrit \<33
- Low-density Lipoprotein (LDL) cholesterol \>190 mg/dl
- HDL cholesterol \<20 mg/dl, to exclude those with rare genetic HDL deficiency syndromes
- Fasting Triglycerides \>500 mg/dl to exclude those with risk of pancreatitis
- ApoE genotypes, E2E2, E2E4, and E4E4.
- Lipid lowering medications
- Hormone replacement therapy
- Other medicines that affect plasma lipid levels: e.g. beta blockers, certain psychiatric medicines including Alprazolam, Chlordiazepoxide, Clonazepam, Diazepam, Lorazepam, Oxazepam, Prazepam, Aripiprazole, Chlorpromazine, Chlorprothixene, Clozapine, Flupenthixol, Fluphenazine, Haloperidol, Loxapine, Mesoridazine, Methotrimeprazine, Molindone, Olanzapine, Perphenazine, Pimozide, Pipotiazine, Prochlorperazine, Promazine, Promethazine, Quetiapine, Risperidone, Sulpiride, Thioridazine, Thiothixene, Trifluoperazine, Ziprasidone.
- Thyrotrophin-stimulating hormone: \<0.5 or \>5.0
- alanine aminotransferase : 1.5 x uln or 60 IU/L
- Aspartate transaminase: 1.5 x uln or 60 IU/L
- Bilirubin: outside upper limit. (\>1.2 mg/dL)
- Creatinine: outside upper limit (\>1.00 mg/dL)
- Diabetes by history
- Diabetes by fasting or post-challenge glycemia according to ADA guidelines:
- Fasting hyperglycemia (glucose \>126 mg/dl).
- Post-challenge glucose by standard oral glucose tolerance test, \>200 mg/dl
- Will not eat the provided diet and abstain from alcoholic beverages.
- Women who are pregnant
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01399632
Start Date
August 1 2010
End Date
December 1 2013
Last Update
July 6 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Harvard T. H. Chan School of Public Health
Boston, Massachusetts, United States, 02215