Palmitoleic Isomer Study

Not Applicable

Completed

• Conditions: Insulin Sensitivity

• Registration Number: NCT02311790
• Lead Sponsor: Tufts University

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.

Study Timeline

• Study First Submitted: 2014-12-04
• Study First Submitted QC: 2014-12-04
• Study First Posted: 2014-12-08
• Study Start: 2015-07
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-31
• Last Update Posted: 2017-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Plasma phospholipid fatty acid profiles -	18 weeks	PLP FA profile determined by gas chromatography

Secondary Outcome Measures

Name	Time	Method
glucose	18 weeks	part of chemistry panel
ALP	18 weeks	alkaline phosphatase - part of chemistry panel
blood urea nitrogen	18 weeks	assessment of kidney function - part of chemistry panel
creatine phosphokinase	18 weeks	muscle enzymes - part of chemistry panel
albumin	18 weeks	part of chemistry panel
HDL-cholesterol	18 weeks	automated immunoturbidimetric assay
CBC	18 weeks	complete blood count
SGPT	18 weeks	serum glutamic pyruvic transaminase - part of chemistry panel
Insulin	18 weeks	determined by ELISA
Clinical Chemistry Profile	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
Plasma sphingolipid profiles -	18 weeks	sphingolipid profile determined by qTOF (quadrupole time of flight mass spectrometry)
SGOT	18 weeks	serum glutamic oxaloacetic transaminase - part of chemistry panel

Trial Locations

Locations (1)

Jean Mayer Human Nutrition Research Center on Aging; 🇺🇸 Boston, Massachusetts, United States