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临床试验/NCT02311790
NCT02311790已完成不适用

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

Tufts University2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2015年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
2
主要终点
Plasma phospholipid fatty acid profiles -

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Cis-C16:1 supplement

Experimental

Volunteers will take cis-C16:1 supplement for 3 weeks

干预措施: Cis-C16:1 supplement (Dietary Supplement)

Trans-C16:1 supplement

Experimental

Volunteers will take trans-C16:1 supplement for 3 weeks

干预措施: Trans-C16:1 supplement (Dietary Supplement)

结局指标

主要结局

Plasma phospholipid fatty acid profiles -

时间窗: 18 weeks

PLP FA profile determined by gas chromatography

次要结局

  • blood urea nitrogen(18 weeks)
  • creatine phosphokinase(18 weeks)
  • glucose(18 weeks)
  • albumin(18 weeks)
  • HDL-cholesterol(18 weeks)
  • CBC(18 weeks)
  • SGPT(18 weeks)
  • Insulin(18 weeks)
  • Clinical Chemistry Profile(18 weeks)
  • ALP(18 weeks)
  • Plasma sphingolipid profiles -(18 weeks)
  • SGOT(18 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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