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DyslipidemiaNCT02145936

Effect of Dietary Fatty Acids on Cardiovascular Disease Risk Indicators and Inflammation

A study testing diet in people with Dyslipidemia, run by Tufts University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to to determine the effect of habituation to diets with different types of dietary fat (stearic, palmitic and oleic) on selected Cardiovascular Disease (CVD) risk indicators with an emphasis on inflammation. 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?
diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Jan 2013to Dec 2017
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

  • The inclusion and exclusion criteria for both studies A and B are identical.
  • 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 <10 ug/dL
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  • Normal fasting plasma glucose levels (<120 mg/dL)
  • 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
  • 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

Other trials in United States

About this study

Official title: Effect of Dietary Fatty Acids on Cardiovascular Disease Risk Indicators and Inflammation.

The purpose of this study is to to determine the effect of habituation to diets with different types of dietary fat (stearic, palmitic and oleic) on selected Cardiovascular Disease (CVD) risk indicators with an emphasis on inflammation.

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. A critical issue remains unresolved - the relative comparability among . The findings from this research study will enable us to understand the mechanism and potential health effect of different types of fats. Each of the diet 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 the 5th week of each diet phase, volunteers will come to the center on 3 consecutive days to provide fasting blood samples and a non-fasting blood sample.

Conditions
Dyslipidemia
Being tested
diet
Keywords
fatty acid
Medical subject headings
Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dietOther

    Participants are fed diets enriched in oleic acid, palmitic acid or stearic acid.

Study groups in NCT02145936
Study groupRoleWhat they receive
oleic acid dietExperimentalParticipants are provided with meals enriched in oleic acid (18:1)
Receives: Other: diet
palmitic acid dietExperimentalParticipants are provided with meals enriched in palmitic acid (18:0)
Receives: Other: diet
stearic acid dietExperimentalParticipants are provided with meals enriched in stearic acid (18:0)
Receives: Other: diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. inflammation

    interleukine (IL)-6, tumor necrosis factor (TNF)-alpha, monocyte chemoattractant protein (MCP)-1, C-reactive protein (CRP), soluble forms of intercellular adhesion protein (slCAM)-1, vascular cell adhesion protein (sVCAM)-1, sE-selectin, sP-selectin and li0poprotein associated phospholipase A2 (LpPLA2).

    Measured: 15-weeks

Secondary outcomes (5)

  1. lymphocyte proliferation and ex vivo cytokine secretion

    IL-1, IL-6, TNF-alpha, and prostaglandin E2 (PGE2)

    Measured: 15 weeks

  2. plasma lipids and lipoproteins

    TC, HDL, LDL

    Measured: 15 weeks

  3. desaturase activity

    8CD, D6D, D5D

    Measured: 15 weeks

  4. insulin sensitivity

    glucose, insulin

    Measured: 15 weeks

  5. coagulation biomarkers

    prothrombin time (PT), partial thromboplastin time (PTT)

    Measured: 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2014 (estimated)
  2. Study startJan 2013
  3. Primary completionJun 2017
  4. Study completionDec 2017

Resources

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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02145936
Sponsor's protocol ID
1541 - Fatty Acid Pilot
Status last verified
Jul 2018
First submitted
3 Feb 2012
Last updated
13 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang W, Matuszek G, Dolnikowski GG, Lamon-Fava S, Ausman LM, Lichtenstein AH, Matthan NR. Differential effects of stearic, palmitic and oleic acid enriched diets on gut microbiome, bile acid and cholesterol metabolism in mildly hypercholesterolemic post-menopausal females: A secondary analysis of a randomized controlled trial. Am J Clin Nutr. 2026 Oct 6:101561. doi: 10.1016/j.ajcnut.2026.101561. Online ahead of print.

    PubMed 42838366

  • Meng H, Matthan NR, Wu D, Li L, Rodriguez-Morato J, Cohen R, Galluccio JM, Dolnikowski GG, Lichtenstein AH. Comparison of diets enriched in stearic, oleic, and palmitic acids on inflammation, immune response, cardiometabolic risk factors, and fecal bile acid concentrations in mildly hypercholesterolemic postmenopausal women-randomized crossover trial. Am J Clin Nutr. 2019 Aug 1;110(2):305-315. doi: 10.1093/ajcn/nqz095.

    PubMed 31179489

Questions about this trial

What is this clinical trial studying?

A study testing 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 30 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 13 Jul 2018. 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?

inflammation (time frame: 15-weeks). 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 NCT02145936, 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 13 Jul 2018.

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