OverweightNCT01399632
Dietary Fat and High-Density Lipoprotein (HDL) Metabolism-Effect of Carbohydrate and Fat Intake
A study testing Low Fat and High Carbohydrate Diet and High Fat and Low Carbohydrate Diet in people with Overweight and Cardiovascular Diseases, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Cardiovascular Diseases
- What is being tested?
- Low Fat and High Carbohydrate Diet and High Fat and Low Carbohydrate Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard T. H. Chan School of Public Health
Boston, Massachusetts, 02215
About this study
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.
Read the 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 20 individuals with low HDL cholesterol and overweight or obesity. The participants will be given the controlled diets for 4 weeks in a randomized crossover design. They will be admitted to the Brigham \& Women's Hospital Center for Clinical Investigation (CCI) the morning of Day 28 when they will be infused intravenously with a stable isotope tracer, trideuterated (D3), leucine for 10 minutes as a bolus. Blood will be sampled in the hospital through 24 hours, and thereafter at the ambulatory clinical center throughout 94 hours. HDL subtypes will be prepared in Dr. Sacks's laboratory at Harvard School of Public Health (HSPH) and analyzed for content of lipids and proteins, and for incorporation of the tracer into apolipoprotein A-I, the principal protein of HDL. These data will be studied by interactive modeling to a multi-compartment model of human HDL physiology that best fits the observed data. The model will yield HDL metabolic rates during unsaturated fat and carbohydrate-rich diets which will be tested for statistical significance.
- Conditions
- Overweight, Cardiovascular Diseases
- Being tested
- Low Fat and High Carbohydrate Diet, High Fat and Low Carbohydrate Diet
- Medical subject headings
- Overweight, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Fat and High Carbohydrate DietBehavioural
Also called Diet and HDL Metabolism
Low Fat and High Carbohydrate Diet
High Fat and Low Carbohydrate DietBehavioural
Also called Diet and HDL Metabolism
High Fat and Low Carbohydrate Diet
| Study group | Role | What they receive |
|---|---|---|
| High Fat and Low Carbohydrate Diet | Experimental | Not described Receives: Behavioral: High Fat and Low Carbohydrate Diet |
| Low Fat and High Carbohydrate Diet | Experimental | Not described Receives: Behavioral: Low Fat and High Carbohydrate Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
high-density lipoprotein (HDL) cholesterol
To determine how dietary unsaturated fat when it replaces carbohydrate affects HDL metabolism.
Measured: Diet Periods I and II-Days 28-32
Secondary outcomes (1)
To study HDL with apoE
Measured: Diet Periods I and II-Days 28-32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startAug 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank M. Sacks, Brigham and Women's Hospital
- Investigators
- Frank M Sacks, MD, Principal investigator, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399632
- Sponsor's protocol ID
- HL095964
- Status last verified
- Jul 2016
- First submitted
- 15 Jul 2011
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30944249Morton 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.
PubMed 29467335
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Fat and High-Density Lipoprotein (HDL) Metabolism-Effect of Carbohydrate and Fat Intake
- ClinicalTrials.gov ID
- NCT01399632
- Acronym / sponsor ID
- HL095964
- Conditions
- Overweight, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 22 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 20 individuals with low HDL cholesterol and overweight or obesity. The participants will be given the controlled diets for 4 weeks in a randomized crossover design. They will be admitted to the Brigham \& Women's Hospital Center for Clinical Investigation (CCI) the morning of Day 28 when they will be infused intravenously with a stable isotope tracer, trideuterated (D3), leucine for 10 minutes as a bolus. Blood will be sampled in the hospital through 24 hours, and thereafter at the ambulatory clinical center throughout 94 hours. HDL subtypes will be prepared in Dr. Sacks's laboratory at Harvard School of Public Health (HSPH) and analyzed for content of lipids and proteins, and for incorporation of the tracer into apolipoprotein A-I, the principal protein of HDL. These data will be studied by interactive modeling to a multi-compartment model of human HDL physiology that best fits the observed data. The model will yield HDL metabolic rates during unsaturated fat and carbohydrate-rich diets which will be tested for statistical significance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Fat and High Carbohydrate DietAlso: Diet and HDL MetabolismLow Fat and High Carbohydrate Diet | Behavioural | Low Fat and High Carbohydrate Diet |
| High Fat and Low Carbohydrate DietAlso: Diet and HDL MetabolismHigh Fat and Low Carbohydrate Diet | Behavioural | High Fat and Low Carbohydrate Diet |
Primary outcome
high-density lipoprotein (HDL) cholesterol
Time frame: Diet Periods I and II-Days 28-32
To determine how dietary unsaturated fat when it replaces carbohydrate affects HDL metabolism.
1 secondary outcome
To study HDL with apoE
Time frame: Diet Periods I and II-Days 28-32
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
- Derived from this study: PubMed 30944249Morton 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.
- Derived from this study: PubMed 29467335Morton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank M Sacks, MD principal investigator
Harvard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Fat and High Carbohydrate Diet and High Fat and Low Carbohydrate Diet in people with Overweight and Cardiovascular Diseases, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
high-density lipoprotein (HDL) cholesterol (time frame: Diet Periods I and II-Days 28-32). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01399632, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.