- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02311790
Palmitoleic Isomer Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- Jean Mayer Human Nutrition Research Center on Aging
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Trans-C16:1 supplement
Volunteers will take trans-C16:1 supplement for 3 weeks
|
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]
|
Experimental: Cis-C16:1 supplement
Volunteers will take cis-C16:1 supplement for 3 weeks
|
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]
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma phospholipid fatty acid profiles -
Time Frame: 18 weeks
|
PLP FA profile determined by gas chromatography
|
18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma sphingolipid profiles -
Time Frame: 18 weeks
|
sphingolipid profile determined by qTOF (quadrupole time of flight mass spectrometry)
|
18 weeks
|
CBC
Time Frame: 18 weeks
|
complete blood count
|
18 weeks
|
Insulin
Time Frame: 18 weeks
|
determined by ELISA
|
18 weeks
|
Clinical Chemistry Profile
Time Frame: 18 weeks
|
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
|
18 weeks
|
HDL-cholesterol
Time Frame: 18 weeks
|
automated immunoturbidimetric assay
|
18 weeks
|
glucose
Time Frame: 18 weeks
|
part of chemistry panel
|
18 weeks
|
albumin
Time Frame: 18 weeks
|
part of chemistry panel
|
18 weeks
|
ALP
Time Frame: 18 weeks
|
alkaline phosphatase - part of chemistry panel
|
18 weeks
|
SGPT
Time Frame: 18 weeks
|
serum glutamic pyruvic transaminase - part of chemistry panel
|
18 weeks
|
SGOT
Time Frame: 18 weeks
|
serum glutamic oxaloacetic transaminase - part of chemistry panel
|
18 weeks
|
blood urea nitrogen
Time Frame: 18 weeks
|
assessment of kidney function - part of chemistry panel
|
18 weeks
|
creatine phosphokinase
Time Frame: 18 weeks
|
muscle enzymes - part of chemistry panel
|
18 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alice H Lichtenstein, D.Sc., Tufts University/Jean Mayer Human Nutrition Research Center on Aging
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11516
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Insulin Sensitivity
-
Paloma Almeda-ValdésCompleted
-
Ingredion IncorporatedUnknownFocus of the Study is Insulin SensitivityUnited States
-
University of Colorado, DenverRecruitingEndothelial Dysfunction | Vascular Stiffness | Insulin Sensitivity/Resistance | TransgenderismUnited States
-
University of Texas, El PasoCompletedInsulin Sensitivity/ResistanceUnited States
-
Rigshospitalet, DenmarkUnknownInsulin Sensitivity and Lipid Metabolism
-
Maastricht University Medical CenterCompletedVascular Function | Nitrate | Brain Insulin-sensitivityNetherlands
-
University of Alabama at BirminghamNot yet recruitingCardiovascular Diseases | Obesity | Insulin Sensitivity/Resistance | Metabolic Disease | Energy Expenditure | MetabolismUnited States
-
University Hospital TuebingenCompletedInsulin SensitivityGermany
-
University of CopenhagenCompleted
-
Marjukka KolehmainenKuopio University HospitalCompleted
Clinical Trials on Trans-C16:1 supplement
-
University of Colorado, DenverInternational Atomic Energy Agency; Universidad Autónoma de QuerétaroCompletedNutritional DeficiencyUnited States, Mexico
-
University of Novi Sad, Faculty of Sport and Physical...Recruiting
-
NestléMiami Research AssociatesCompleted
-
Nutricia UK LtdCompleted
-
Universitat de LleidaLactalisRecruitingGlucose Metabolism DisordersSpain
-
NestléUniversity of the PhilippinesCompletedDiarrhea | Acute Respiratory InfectionPhilippines
-
Taipei Medical UniversityTaipei Medical University WanFang HospitalCompletedMalnutrition | Cancer of Liver | Nutrition Aspect of Cancer | Cancer of ColonTaiwan
-
Southeast Bariatrics, PAUniversity of North Carolina, CharlotteUnknown
-
AB Biotics, SACentre for the Development of Industrial Technology, Ministry of Science...RecruitingMicrobial ColonizationSpain
-
King's College LondonGuy's and St Thomas' NHS Foundation Trust; University of Liverpool; Universidad...Completed