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

NCT01399632 | Completed

• 1 other identifier: HL095964
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Overweight; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• high-density lipoprotein (HDL) cholesterol

  To determine how dietary unsaturated fat when it replaces carbohydrate affects HDL metabolism.

  Diet Periods I and II-Days 28-32

Secondary Outcomes (1)

• To study HDL with apoE

  Diet Periods I and II-Days 28-32

Other Outcomes (1)

• Provide guidance for interpreting effects of unsaturated fats on reverse cholesterol transport

  Diet Periods I and II-Days 28-32

Study Arms (2)

High Fat and Low Carbohydrate Diet

EXPERIMENTAL

Behavioral: High Fat and Low Carbohydrate Diet

Low Fat and High Carbohydrate Diet

EXPERIMENTAL

Behavioral: Low Fat and High Carbohydrate Diet

Interventions

Low Fat and High Carbohydrate Diet BEHAVIORAL

Low Fat and High Carbohydrate Diet

Also known as: Diet and HDL Metabolism

Low Fat and High Carbohydrate Diet

High Fat and Low Carbohydrate Diet BEHAVIORAL

High Fat and Low Carbohydrate Diet

Also known as: Diet and HDL Metabolism

High Fat and Low Carbohydrate Diet

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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:

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Harvard T. H. Chan School of Public Health

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

• Morton AM, Furtado JD, Mendivil CO, Sacks FM. Dietary unsaturated fat increases HDL metabolic pathways involving apoE favorable to reverse cholesterol transport. JCI Insight. 2019 Apr 4;4(7):e124620. doi: 10.1172/jci.insight.124620. eCollection 2019 Apr 4.

  PMID: 30944249 DERIVED

• Morton AM, Koch M, Mendivil CO, Furtado JD, Tjonneland A, Overvad K, Wang L, Jensen MK, Sacks FM. Apolipoproteins E and CIII interact to regulate HDL metabolism and coronary heart disease risk. JCI Insight. 2018 Feb 22;3(4):e98045. doi: 10.1172/jci.insight.98045. eCollection 2018 Feb 22.

  PMID: 29467335 DERIVED

MeSH Terms

Conditions

Overweight; Cardiovascular Diseases

Interventions

Diet, Fat-Restricted; Diet; Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Frank M Sacks, MD

  Harvard University

  PRINCIPAL INVESTIGATOR

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: MD

Study Record Dates

• First Submitted: July 15, 2011
• First Posted: July 22, 2011
• Study Start: August 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 6, 2016

Record last verified: 2016-07

Locations

US (1)