DyslipidemiaNCT02312492
Development of a Novel Method to Study in Vivo Fatty Acid Metabolism Using Stable Isotope Labeled Fatty Acids in Humans
A study testing Oleic Diet, Palmitic Diet and Stearic Diet in people with Dyslipidemia, run by Tufts University at 1 site in United States.
Trial summary
Specific Aim 1: To compare the metabolic fate (transport, conversion and oxidation) of labeled 18:0 (13C18:0) and its metabolic product 18:1 (13C18:1) in the fed state after habituation to diets enriched in the corresponding fatty acid. Read more about this study
- Who is it for?
- Ages 50 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Oleic Diet, Palmitic Diet and Stearic Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Dec 2018
- 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 50 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women (menopause defined by complete natural cessation of menses for >12 months or a bilateral oophorectomy).
- Age >50 to < 85 years
- BMI >20 to <35 kg/m2
- LDL-cholesterol >100 mg/dL
- CRP (C reactive protein) <10 ug/dL
- Normal fasting plasma glucose levels (<120 mg/dL)
Show all 29Show fewer
- Not taking medication known to affect lipid metabolism:
- HMG-CoA reductase inhibitors (statins)
- Bile Acid Sequestrants (Cholestyramine, Colestipol, Colesevelam, etc.)
- Cholesterol Absorption Inhibitors (Ezetimibe [Zetia])
- Nicotinic Acid Agents (Niacin, Niacor, Slo-Niacin, etc)
- Fibrates (Gemfibrozil, Clofibrate, Ciprofibrate, Fenofibrate [Tricor], etc)
- Probucol
- Anticoagulants (Coumadin, Heparin, Plavix, etc)
- Hormone therapy medications containing estrogen
- Acetylsalicylic acid containing medications, aspirin
- Diphenylhydantoin
- Supplements containing fatty acids (Fish Oil, Flaxseed, etc.) and any other compounds that affect lipid metabolism (red yeast rice, etc.) for at least 3 months prior to participation in the study
- Anabolic steroids
- Hydrocortisone
- Normal kidney function as assessed by serum creatinine and blood urea nitrogen
- Normal liver function as assessed by serum glutamic pyruvic transaminase, serum glutamic oxaloacetic transaminase and alkaline phosphatase
- Normal thyroid function as assessed by serum TSH (thyroid stimulating hormone)
- Normal gastrointestinal function
- Normotensive on or off medication
- Non-smoker for at least 2 years
- Alcohol intake < 7 drinks per week, and willingness to abstain from consuming alcohol while participating in the study.
- Consistent physical activity
- Willingness to follow protocol as detailed in the Institutional Review Board (IRB) approved consent form.
Who cannot join
- Men
- Women who have had a double mastectomy
- Age < 50 and > 85 years
- BMI < 20 and > 35 kg/m2
- LDL-cholesterol <100 mg/dL
- CRP > 10 ug/dL
Show all 39Show fewer
- Abnormal fasting plasma glucose levels >120 mg/dL
- Use of medications known to affect lipid metabolism:
- HMG-CoA reductase inhibitors (statins)
- Bile Acid Sequestrants (Cholestyramine, Colestipol, Colesevelam, etc.)
- Cholesterol Absorption Inhibitors (Ezetimibe [Zetia])
- Nicotinic Acid Agents (Niacin, Niacor, Slo-Niacin, etc)
- Fibrates (Gemfibrozil, Clofibrate, Ciprofibrate, Fenofibrate [Tricor], etc)
- Anticoagulants (Coumadin, Heparin, Plavix, etc)
- Hormone therapy medications containing estrogen
- Probucol
- Acetylsalicylic acid containing medications, aspirin
- Diphenylhydantoin
- Supplements containing fatty acids (Fish Oil, Flaxseed, etc.) and any other compounds that affect lipid metabolism (red yeast rice, etc.) in the last 3 months prior to participation in the study
- Anabolic steroids and hydrocortisone
- Renal or kidney disease, as defined by a history of chronic kidney disease or by glomerular filtration rate of < 60 ml.min/1.73 m2 calculated from screening blood tests.
- Hypothyroidism or hyperthyroidism, as defined as screening TSH outside of normal ranges (<0.4 or >4.5), unless controlled with medication for at least 6 months
- Gastrointestinal disease
- Uncontrolled hypertension or high BP reading at the discretion of the study physician or nurse
- Established cardiovascular disease as defined by history of myocardial infarction, stroke, heart failure, coronary artery bypass graft, stenosis >50%, angina and peripheral arterial disease)
- Anemia, as defined by screening haemoglobin <11.7g/dL.
- Liver disease, as defined by a history of chronic hepatitis B or C, cholestatic or cirrhotic liver disease, nonalcoholic fatty liver disease, elevations of SGPT or SGOT greater than 1.5 times the upper limit of normal at screening, bilirubin greater than 2 mg/dL (in the absence of benign causes of elevated bilirubin such as Gilbert's syndrome) at screening, or albumin below the lower limit of normal.
- Type I and II diabetes
- Any non-steroidal anti-inflammatory drugs (NSAID) or antihistamine use by subject for 72 hours prior to blood draws
- Smoking or use of nicotine-containing products within the past 2 years
- Alcohol intake > 7 drinks per week or unwillingness to abstain from consuming alcohol while participating in the study
- Unwillingness to maintain body weight during participation in the study
- Unwillingness to adhere to diet and study protocol
- Weight gain or loss of more than 15 lb within 6 months prior to enrollment
- Vegetarians and those with food allergies or aversions
- Non-English speaking subjects
- No Social Security number
- Women who have a history of difficulty with blood draws
- Blood donation within the past 8 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer Human Nutrition Research Center on Aging
Boston, Massachusetts, 02111
About this study
Official title: Development of a Novel Method to Study in Vivo Fatty Acid Metabolism Using Stable Isotope Labeled Fatty Acids in Humans.
Specific Aim 1: To compare the metabolic fate (transport, conversion and oxidation) of labeled 18:0 (13C18:0) and its metabolic product 18:1 (13C18:1) in the fed state after habituation to diets enriched in the corresponding fatty acid.
Hypothesis: In the fed state, the metabolic fate of 13C18:0 compared to 13C18:1 will be characterized by similar transport, higher conversion, and similar oxidation rates..
Read the detailed description
Vegetable oils high in the specific fatty acids of interest - stearic (found in cocoa butter, meats), palmitic (found in meats, dairy and some plant oils) and stearic acid's metabolic product, oleic (found in olive and corn oil) - will be used to displace each other in a standardized diet and fed to mildly hypercholesterolemic postmenopausal women using a randomized-controlled crossover design. Six women who are enrolled in 10150 - Study A will be invited to participate in this study. Each of the phases will be 5 weeks in length with a 2-4 week break between phases. All food and drink will be provided to study volunteers. Blood pressure and body weight will be monitored once per week and adjustments made, if necessary, to maintain a stable weight. During week 1 of the 18:0 and 18:1 dietary phases, a fasting blood sample will be drawn. A single stool sample will be collected on any of the study visits after week three. On Day 1 of week 5, following a 12 hour fast, each volunteer will receive their usual diet divided into 15 hourly small meals. A purified tracer dose (1 mg/kg bodyweight [BW]) of 13C fatty acid will be incorporated into the 1pm meal. Blood samples will be collected from a catheter inserted into the subcubital vein just before consuming the first hourly meal and then 2, 5, 7, 8, 9, 11, 13 and 15 hours thereafter. Breath samples will be collected before the first hourly meal as well as at various time-points after. Additional fasting blood samples will be collected on Days 2, 3, 4 and 5 of the 18:0 and 18:1 diet phases. At the end of Day 1, volunteers will have the option of returning home or staying overnight at the Jean Mayer Human Nutrition Research Center.
- Conditions
- Dyslipidemia
- Being tested
- Oleic Diet, Palmitic Diet, Stearic Diet
- Keywords
- fatty acid kinetics
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oleic DietOther
Also called Diet enriched in oleic acid, 18:1
The 18:1 (oleic) diet will contain 55%E carbohydrate, 15%E protein, 30%E fat, 100 mg cholesterol/1000 kcal and 15 g fiber/1000 kcal. The vegetable oils and/or fats (henceforth collectively referred to as experimental oils) that will be used to formulate the diets were selected not only take into account the fatty acid of interest but also the fatty acid displaced within the context of an unchanged total fat content. This was accomplished by formulating a diet containing 10%E fat and then adding the experimental oils (oleic) to 30%E total fat by incorporating them into various food items intended for consumption throughout the day. The actual food items comprising the 3 diets will be similar, only differing in the experimental oils.
Palmitic DietOther
Also called Diet enriched in palmitic acid., 16:0
The 16:0 (palmitic) diet will contain 55%E carbohydrate, 15%E protein, 30%E fat, 100 mg cholesterol/1000 kcal and 15 g fiber/1000 kcal. The vegetable oils and/or fats (henceforth collectively referred to as experimental oils) that will be used to formulate the diets were selected not only take into account the fatty acid of interest but also the fatty acid displaced within the context of an unchanged total fat content. This was accomplished by formulating a diet containing 10%E fat and then adding the experimental oils (palmitic) to 30%E total fat by incorporating them into various food items intended for consumption throughout the day. The actual food items comprising the 3 diets will be similar, only differing in the experimental oils.
Stearic DietOther
Also called Stearic acid enriched diet., 18:0
The 18:0 diet (stearic) will contain 55%E carbohydrate, 15%E protein, 30%E fat, 100 mg cholesterol/1000 kcal and 15 g fiber/1000 kcal. The vegetable oils and/or fats (henceforth collectively referred to as experimental oils) that will be used to formulate the diets were selected not only take into account the fatty acid of interest but also the fatty acid displaced within the context of an unchanged total fat content. This was accomplished by formulating a diet containing 10%E fat and then adding the experimental oil (stearic) to 30%E total fat by incorporating them into various food items intended for consumption throughout the day. The actual food items comprising the 3 diets will be similar, only differing in the experimental oils.
| Study group | Role | What they receive |
|---|---|---|
| 18:1 diet | Experimental | Oleic Diet - volunteers will consume oleic enriched food for a period of 5 weeks. Receives: Other: Oleic Diet |
| 16:0 diet | Experimental | Palmitic diet - Volunteers will consume palmitic enriched food for a period of 5 weeks. Receives: Other: Palmitic Diet |
| 18:0 | Experimental | Stearic Diet - Volunteers will receive Stearic enriched food for a period of 5 weeks. Receives: Other: Stearic Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
fatty acid kinetics in total plasma
measurement of isotope ratio (13C:12C) in total plasma, cholesterol ester, triglyceride, phospholipid, monoglyceride and diglyceride subfractions as well as chylomicrons, VLDL (very low density lipoprotein), TRL (triglyceride-rich lipoprotein), LDL (low density lipoprotein) and HDL (high density lipoprotein).
Measured: 15 weeks
fatty acid kinetics in cholesterol ester
Measured: 15 weeks
fatty acid kinetics in triglyceride
Measured: 15 weeks
fatty acid kinetics in phospholipid
Measured: 15 weeks
fatty acid kinetics in monoglyceride subfraction
Measured: 15 weeks
fatty acid kinetics in diglyceride subfraction
Measured: 15 weeks
fatty acid kinetics in chylomicrons
Measured: 15 weeks
fatty acid kinetics in VLDL (very low density lipoprotein)
Measured: 15 weeks
fatty acid kinetics in TRL (triglyceride-rich lipoprotein)
Measured: 15 weeks
fatty acid kinetics in LDL (low density lipoprotein)
Measured: 15 weeks
fatty acid kinetics in HDL (high density lipoprotein)
Measured: 15 weeks
Secondary outcomes (1)
rate of oxidation
breath analysis will be conducted to determine rate of oxidation
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startJan 2013
- Primary completionJun 2016
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alice H Lichtenstein, D.Sc., Principal investigator, Tufts University/HNRCA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312492
- Sponsor's protocol ID
- 1542 - Fatty Acid Kinetics
- Status last verified
- Apr 2019
- First submitted
- 4 Jun 2014
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Novel Method to Study in Vivo Fatty Acid Metabolism Using Stable Isotope Labeled Fatty Acids in Humans.
- ClinicalTrials.gov ID
- NCT02312492
- Acronym / sponsor ID
- 1542 - Fatty Acid Kinetics
- Conditions
- Dyslipidemia
- Keywords
- fatty acid kinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 9 Dec 2014 (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.
Specific Aim 1: To compare the metabolic fate (transport, conversion and oxidation) of labeled 18:0 (13C18:0) and its metabolic product 18:1 (13C18:1) in the fed state after habituation to diets enriched in the corresponding fatty acid.
Hypothesis: In the fed state, the metabolic fate of 13C18:0 compared to 13C18:1 will be characterized by similar transport, higher conversion, and similar oxidation rates..
Detailed description
Vegetable oils high in the specific fatty acids of interest - stearic (found in cocoa butter, meats), palmitic (found in meats, dairy and some plant oils) and stearic acid's metabolic product, oleic (found in olive and corn oil) - will be used to displace each other in a standardized diet and fed to mildly hypercholesterolemic postmenopausal women using a randomized-controlled crossover design. Six women who are enrolled in 10150 - Study A will be invited to participate in this study. Each of the phases will be 5 weeks in length with a 2-4 week break between phases. All food and drink will be provided to study volunteers. Blood pressure and body weight will be monitored once per week and adjustments made, if necessary, to maintain a stable weight. During week 1 of the 18:0 and 18:1 dietary phases, a fasting blood sample will be drawn. A single stool sample will be collected on any of the study visits after week three. On Day 1 of week 5, following a 12 hour fast, each volunteer will receive their usual diet divided into 15 hourly small meals. A purified tracer dose (1 mg/kg bodyweight [BW]) of 13C fatty acid will be incorporated into the 1pm meal. Blood samples will be collected from a catheter inserted into the subcubital vein just before consuming the first hourly meal and then 2, 5, 7, 8, 9, 11, 13 and 15 hours thereafter. Breath samples will be collected before the first hourly meal as well as at various time-points after. Additional fasting blood samples will be collected on Days 2, 3, 4 and 5 of the 18:0 and 18:1 diet phases. At the end of Day 1, volunteers will have the option of returning home or staying overnight at the Jean Mayer Human Nutrition Research Center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 18:1 diet | Experimental | Other: Oleic DietOleic Diet - volunteers will consume oleic enriched food for a period of 5 weeks. |
| 16:0 diet | Experimental | Other: Palmitic DietPalmitic diet - Volunteers will consume palmitic enriched food for a period of 5 weeks. |
| 18:0 | Experimental | Other: Stearic DietStearic Diet - Volunteers will receive Stearic enriched food for a period of 5 weeks. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Postmenopausal women (menopause defined by complete natural cessation of menses for >12 months or a bilateral oophorectomy).
- Age >50 to < 85 years
- BMI >20 to <35 kg/m2
- LDL-cholesterol >100 mg/dL
- CRP (C reactive protein) <10 ug/dL
Key exclusion criteria (39 listed)
- Men
- Women who have had a double mastectomy
- Age < 50 and > 85 years
- BMI < 20 and > 35 kg/m2
- LDL-cholesterol <100 mg/dL
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 |
|---|---|---|
| Oleic DietAlso: Diet enriched in oleic acid, 18:1The 18:1 (oleic) diet will contain 55%E carbohydrate, 15%E protein, 30%E fat, 100 mg cholesterol/1000 kcal and 15 g fiber/1000 kcal. The vegetable oils and/or fats (henceforth collectively referred to as experimental oils) that will be used to formulate the diets were selected not only take into account the fatty acid of interest but also the fatty acid displaced within the context of an unchanged total fat content. This was accomplished by formulating a diet containing 10%E fat and then adding the experimental oils (oleic) to 30%E total fat by incorporating them into various food items intended for consumption throughout the day. The actual food items comprising the 3 diets will be similar, only differing in the experimental oils. | Other | 18:1 diet |
| Palmitic DietAlso: Diet enriched in palmitic acid., 16:0The 16:0 (palmitic) diet will contain 55%E carbohydrate, 15%E protein, 30%E fat, 100 mg cholesterol/1000 kcal and 15 g fiber/1000 kcal. The vegetable oils and/or fats (henceforth collectively referred to as experimental oils) that will be used to formulate the diets were selected not only take into account the fatty acid of interest but also the fatty acid displaced within the context of an unchanged total fat content. This was accomplished by formulating a diet containing 10%E fat and then adding the experimental oils (palmitic) to 30%E total fat by incorporating them into various food items intended for consumption throughout the day. The actual food items comprising the 3 diets will be similar, only differing in the experimental oils. | Other | 16:0 diet |
| Stearic DietAlso: Stearic acid enriched diet., 18:0The 18:0 diet (stearic) will contain 55%E carbohydrate, 15%E protein, 30%E fat, 100 mg cholesterol/1000 kcal and 15 g fiber/1000 kcal. The vegetable oils and/or fats (henceforth collectively referred to as experimental oils) that will be used to formulate the diets were selected not only take into account the fatty acid of interest but also the fatty acid displaced within the context of an unchanged total fat content. This was accomplished by formulating a diet containing 10%E fat and then adding the experimental oil (stearic) to 30%E total fat by incorporating them into various food items intended for consumption throughout the day. The actual food items comprising the 3 diets will be similar, only differing in the experimental oils. | Other | 18:0 |
Primary outcome
fatty acid kinetics in total plasma
Time frame: 15 weeks
measurement of isotope ratio (13C:12C) in total plasma, cholesterol ester, triglyceride, phospholipid, monoglyceride and diglyceride subfractions as well as chylomicrons, VLDL (very low density lipoprotein), TRL (triglyceride-rich lipoprotein), LDL (low density lipoprotein) and HDL (high density lipoprotein).
fatty acid kinetics in cholesterol ester
Time frame: 15 weeks
fatty acid kinetics in triglyceride
Time frame: 15 weeks
fatty acid kinetics in phospholipid
Time frame: 15 weeks
fatty acid kinetics in monoglyceride subfraction
Time frame: 15 weeks
fatty acid kinetics in diglyceride subfraction
Time frame: 15 weeks
fatty acid kinetics in chylomicrons
Time frame: 15 weeks
fatty acid kinetics in VLDL (very low density lipoprotein)
Time frame: 15 weeks
fatty acid kinetics in TRL (triglyceride-rich lipoprotein)
Time frame: 15 weeks
fatty acid kinetics in LDL (low density lipoprotein)
Time frame: 15 weeks
fatty acid kinetics in HDL (high density lipoprotein)
Time frame: 15 weeks
1 secondary outcome
rate of oxidation
Time frame: 15 weeks
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 18 Apr 2019.
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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.
Alice H Lichtenstein, D.Sc. principal investigator
Tufts University/HNRCA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oleic Diet, Palmitic Diet and Stearic Diet in people with Dyslipidemia, run by Tufts University 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 29 inclusion and 39 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 18 Apr 2019. 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?
fatty acid kinetics in total plasma (time frame: 15 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2019.