Dietary Fat and High-Density Lipoprotein (HDL) Metabolism-Effect of Carbohydrate and Fat Intake

Completed · Not applicable

Conditions studied: Overweight, Cardiovascular Diseases

In brief

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 (saturated) or beneficial type (unsaturated) raises HDL levels. Dietary carbohydrate lowers HDL. The investigators are doing this research study to find out why the amount of HDL in a person's blood is affected by dietary unsaturated fat and carbohydrate. The investigators will trace the ability of the HDL in a person's blood to take up cholesterol, get bigger, and then leave the blood by passing into the liver. The investigators want to know if dietary unsaturated fat improves the ability of HDL to do this compared to dietary carbohydrate.

Key facts

Study ID

NCT01399632

Run by

Brigham and Women's Hospital

People needed

21

Starts

2010-08-01

Expected to finish

2013-12-01

Last updated by the study team

2016-07-06

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Harvard T. H. Chan School of Public Health — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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