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Palmitoleic Isomer Study

NCT02311790 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2017-09-01

No results posted yet for this study

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.

Conditions

  • Insulin Sensitivity

Interventions

DIETARY_SUPPLEMENT

Trans-C16:1 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 \[9 weeks total\]

DIETARY_SUPPLEMENT

Cis-C16:1 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 \[9 weeks total\]

Sponsors & Collaborators

  • Tufts University

    lead OTHER

Principal Investigators

  • Alice H Lichtenstein, D.Sc. · Tufts University/Jean Mayer Human Nutrition Research Center on Aging

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02311790 on ClinicalTrials.gov