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Insulin SensitivityNCT02311790

Palmitoleic Isomer Study

A study testing Trans-C16:1 supplement and Cis-C16:1 supplement in people with Insulin Sensitivity, 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

Trans-palmitoleic acid (trans-C16:1) is a naturally occurring trans fatty acid present in small quantities in foods, most notably in dairy products. Observational evidence suggests a positive association between trans-C16:1 and insulin sensitivity, and negative association with risk of developing type 2 diabetes… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Insulin Sensitivity
What is being tested?
Trans-C16:1 supplement and Cis-C16:1 supplement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
Jul 2015to Apr 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 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult
  1. Inclusion criteria:
  • Age ≥ 18 to ≤ 70 years
  • BMI ≥ 25 kg/m2 ≤ 40 kg/m2
  • Normotensive with or without medication
  • Normal fasting plasma glucose levels (≤120 mg/dL)
  • Normal kidney function as assessed by serum creatinine and blood urea nitrogen
  • Normal liver function as assessed by serum glutamic pyruvic transaminase (SGPT), serum glutamic oxaloacetic transaminase (SGOT) and alkaline phosphatase (ALP)
  • Normal thyroid function defined as screening TSH within normal ranges, without or with medication for at least 6 months
  • Normal gastrointestinal function
  1. Exclusion criteria:
  • Use of supplements containing fish oil or other lipid supplements (e.g., flaxseed, primrose oil, sea buckthorn oil) within 3 months of study participation
  • Greater than 2 servings/day combined of cheese, whole-fat milk or whole-fat yogurt
  • Diagnosed diabetes mellitus Type I or Type II and/or taking glucose lowering medications (e.g., metformin, actos, januvia)
  • Use of medication known to affect lipid metabolism (HMG-CoA reductase inhibitors (statins, red yeast rice), bile acid sequestrants, cholesterol absorption inhibitors (exetimibe [Zetia]), nicotinic acid agents, fibrates, probucol, anticoagulants, hormone therapy medications containing estrogen, anabolic steroids)
  • Established major chronic diseases such as major cardiovascular disease (history of myocardial infarction, stroke, symptomatic heart failure, coronary artery bypass graft, or symptomatic peripheral arterial disease), active cancer, end stage renal disease, dementia, severe chronic obstructive pulmonary disease, significant liver disease
  • Pregnancy or breastfeeding
  • Unwillingness to adhere to study protocol
  • No Social Security number (for payment and IRS forms).

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: Supplementation With Vegetable Oils Enriched in the Fatty Acids Trans-C16:1 or Cis-C16:1: Dose-response Study

Trans-palmitoleic acid (trans-C16:1) is a naturally occurring trans fatty acid present in small quantities in foods, most notably in dairy products. Observational evidence suggests a positive association between trans-C16:1 and insulin sensitivity, and negative association with risk of developing type 2 diabetes mellitus [1-3]. Cis-palmitoleic acid (cis-C16:1) is found naturally in foods and is particularly high in macadamia nuts and oil extracted from the sea buckthorn plant. Animal models suggest that this palmitoleic acid isomer also improves insulin sensitivity and reduces metabolic dysfunction.

This pilot dosing study is necessary to inform the design of a larger trial to test the hypothesis that both trans-C16:1 and cis-C16:1 improve insulin resistance but at different doses. Plasma phospholipid fatty acid profiles will be used as the primary outcome measure.

Read the detailed description

The fatty acids trans-C16:1 and cis-C16:1 have been associated with healthy plasma glucose levels. Elevated glucose levels have been associated with diabetes. This study is designed to determine whether there is a dose-response relation between how much trans-C16:1 and cis-C16:1 you consume and how much appears in plasma. This information will be used to design a future study to determine whether trans-C16:1 and cis-C16:1 could be used to treat diabetes. Trans-C16:1 occurs naturally in dairy fat such as milk and cheese, while cis-C16:1 occurs naturally in nuts, particularly, macadamia nuts, and a plant called sea buckthorn. The study will consist of two 9-week phases, with a minimum of a 4 week off-study period between the two phases. Fasting blood will be drawn at baseline (first day of week 1), 3 weeks, 6 weeks and 9 weeks (4 total blood draws per phase or 8 total blood draws for 2 phases). During each phase you will be asked to consume increasing numbers of vegetable oil capsules, 2 per day during the first 3 weeks, 4 per day during the second 3 weeks, and 8 per day during the third 3 weeks. During each of these periods you should take half the capsules in the morning and half in the evening, with your meals. You will be randomly assigned to receive the trans-C16:1 or cis-C16:1 during the first phase and the other during the second phase. The total length of the study is about 18 weeks, not including the break between phase 1 and phase 2 (not less than 4 weeks). The trans-C16:1 in the capsules will be in the form of partially-hydrogenated soybean oil. The cis-C16:1 in the other capsules will be in the form of sea buckthorn oil.

Being tested
Trans-C16:1 supplement, Cis-C16:1 supplement
Keywords
cis-C16:1n7 supplement, trans-C16:1n7 supplement, palmitoleic acid supplement
Medical subject headings
Insulin Resistance

What participants receive

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

  • Trans-C16:1 supplementDietary supplement

    Each volunteer will consume 3 escalating doses (120 mg/day, 240 mg/day and 480 mg/day) of trans-C16:1 enriched vegetable oil for 3 weeks each (3 doses x 3 weeks each [9 weeks total]

  • Cis-C16:1 supplementDietary supplement

    Each volunteer will consume 3 escalating doses (380 mg/day, 760 mg/day and 1520 mg/day) of cis-C16:1 enriched vegetable oil for 3 weeks each (3 doses x 3 weeks each [9 weeks total]

Study groups in NCT02311790
Study groupRoleWhat they receive
Trans-C16:1 supplementExperimentalVolunteers will take trans-C16:1 supplement for 3 weeks
Receives: Dietary Supplement: Trans-C16:1 supplement
Cis-C16:1 supplementExperimentalVolunteers will take cis-C16:1 supplement for 3 weeks
Receives: Dietary Supplement: Cis-C16:1 supplement

What is being measured

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

  1. Plasma phospholipid fatty acid profiles -

    PLP FA profile determined by gas chromatography

    Measured: 18 weeks

Secondary outcomes (12)

  1. Plasma sphingolipid profiles -

    sphingolipid profile determined by qTOF (quadrupole time of flight mass spectrometry)

    Measured: 18 weeks

  2. CBC

    complete blood count

    Measured: 18 weeks

  3. Insulin

    determined by ELISA

    Measured: 18 weeks

  4. Clinical Chemistry Profile

    glucose, albumin, ALP, SGPT, SGOT, blood urea nitrogen, creatine phosphokinase, creatinine, lactate dehydrogenase, total protein, bilirubin, globulin, albumin/globulin ratio, uric acid, calcium, phosphorus, magnesium, sodium, potassium, chloride, total and LDL-cholesterol, triglyceride

    Measured: 18 weeks

  5. HDL-cholesterol

    automated immunoturbidimetric assay

    Measured: 18 weeks

  6. glucose

    part of chemistry panel

    Measured: 18 weeks

  7. albumin

    part of chemistry panel

    Measured: 18 weeks

  8. ALP

    alkaline phosphatase - part of chemistry panel

    Measured: 18 weeks

  9. SGPT

    serum glutamic pyruvic transaminase - part of chemistry panel

    Measured: 18 weeks

  10. SGOT

    serum glutamic oxaloacetic transaminase - part of chemistry panel

    Measured: 18 weeks

  11. blood urea nitrogen

    assessment of kidney function - part of chemistry panel

    Measured: 18 weeks

  12. creatine phosphokinase

    muscle enzymes - part of chemistry panel

    Measured: 18 weeks

Timeline

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

  1. First posted8 Dec 2014 (estimated)
  2. Study startJul 2015
  3. Primary completionApr 2017
  4. Study completionApr 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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02311790
Sponsor's protocol ID
11516
Status last verified
Aug 2017
First submitted
4 Dec 2014
Last updated
1 Sep 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Huang NK, Matthan NR, Galluccio JM, Shi P, Lichtenstein AH, Mozaffarian D. Supplementation with Seabuckthorn Oil Augmented in 16:1n-7t Increases Serum Trans-Palmitoleic Acid in Metabolically Healthy Adults: A Randomized Crossover Dose-Escalation Study. J Nutr. 2020 Jun 1;150(6):1388-1396. doi: 10.1093/jn/nxaa060.

    PubMed 32140719

Questions about this trial

What is this clinical trial studying?

A study testing Trans-C16:1 supplement and Cis-C16:1 supplement in people with Insulin Sensitivity, 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?

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 1 Sep 2017. 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?

Plasma phospholipid fatty acid profiles - (time frame: 18 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 NCT02311790, which also lists 1 linked publication.

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 1 Sep 2017.

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