Back to resultsPalmitoleic Isomer Study
Primary Purpose
Insulin Sensitivity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trans-C16:1 supplement
Cis-C16:1 supplement
Sponsored by
About this trial
This is an interventional other trial for Insulin Sensitivity focused on measuring cis-C16:1n7 supplement, trans-C16:1n7 supplement, palmitoleic acid supplement
Eligibility Criteria
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).
Sites / Locations
- Jean Mayer Human Nutrition Research Center on Aging
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Trans-C16:1 supplement
Cis-C16:1 supplement
Arm Description
Volunteers will take trans-C16:1 supplement for 3 weeks
Volunteers will take cis-C16:1 supplement for 3 weeks
Outcomes
Primary Outcome Measures
Plasma phospholipid fatty acid profiles -
PLP FA profile determined by gas chromatography
Secondary Outcome Measures
Plasma sphingolipid profiles -
sphingolipid profile determined by qTOF (quadrupole time of flight mass spectrometry)
CBC
complete blood count
Insulin
determined by ELISA
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
HDL-cholesterol
automated immunoturbidimetric assay
glucose
part of chemistry panel
albumin
part of chemistry panel
ALP
alkaline phosphatase - part of chemistry panel
SGPT
serum glutamic pyruvic transaminase - part of chemistry panel
SGOT
serum glutamic oxaloacetic transaminase - part of chemistry panel
blood urea nitrogen
assessment of kidney function - part of chemistry panel
creatine phosphokinase
muscle enzymes - part of chemistry panel
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02311790
Brief Title
Palmitoleic Isomer Study
Official Title
Supplementation With Vegetable Oils Enriched in the Fatty Acids Trans-C16:1 or Cis-C16:1: Dose-response Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Sensitivity
Keywords
cis-C16:1n7 supplement, trans-C16:1n7 supplement, palmitoleic acid supplement
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trans-C16:1 supplement
Arm Type
Experimental
Arm Description
Volunteers will take trans-C16:1 supplement for 3 weeks
Arm Title
Cis-C16:1 supplement
Arm Type
Experimental
Arm Description
Volunteers will take cis-C16:1 supplement for 3 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Trans-C16:1 supplement
Intervention Description
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]
Intervention Type
Dietary Supplement
Intervention Name(s)
Cis-C16:1 supplement
Intervention Description
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]
Primary Outcome Measure Information:
Title
Plasma phospholipid fatty acid profiles -
Description
PLP FA profile determined by gas chromatography
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Plasma sphingolipid profiles -
Description
sphingolipid profile determined by qTOF (quadrupole time of flight mass spectrometry)
Time Frame
18 weeks
Title
CBC
Description
complete blood count
Time Frame
18 weeks
Title
Insulin
Description
determined by ELISA
Time Frame
18 weeks
Title
Clinical Chemistry Profile
Description
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
Time Frame
18 weeks
Title
HDL-cholesterol
Description
automated immunoturbidimetric assay
Time Frame
18 weeks
Title
glucose
Description
part of chemistry panel
Time Frame
18 weeks
Title
albumin
Description
part of chemistry panel
Time Frame
18 weeks
Title
ALP
Description
alkaline phosphatase - part of chemistry panel
Time Frame
18 weeks
Title
SGPT
Description
serum glutamic pyruvic transaminase - part of chemistry panel
Time Frame
18 weeks
Title
SGOT
Description
serum glutamic oxaloacetic transaminase - part of chemistry panel
Time Frame
18 weeks
Title
blood urea nitrogen
Description
assessment of kidney function - part of chemistry panel
Time Frame
18 weeks
Title
creatine phosphokinase
Description
muscle enzymes - part of chemistry panel
Time Frame
18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice H Lichtenstein, D.Sc.
Organizational Affiliation
Tufts University/Jean Mayer Human Nutrition Research Center on Aging
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jean Mayer Human Nutrition Research Center on Aging
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32140719
Citation
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.
Results Reference
derived
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Palmitoleic Isomer Study
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