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临床试验/NCT06533891
NCT06533891撤回不适用

Effects of Omega-3 Fatty Acid Supplementation and Physical Training on Metabolic Health

University of Arizona0 个研究点开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Triglyceride/HDL-C ratio

研究概览

简要总结

The degree of insulin resistance in an individual can be monitored by several means including blood concentrations of insulin, triglycerides, HDL-C, and eventually glucose. In particular, the ratio of triglycerides to HDL-C reflects the severity of insulin resistance's impact on liver-mediated lipoprotein transport and may be a sensitive measure of early insulin resistance when fasting glucose levels are still in the normal range (compensated by higher output of insulin). High triglycerides and low HDL-C indicate poor metabolic health and increased risk of fatty liver and atherosclerotic cardiovascular diseases.

Two diet and lifestyle strategies that have shown therapeutic promise are 1) supplementation with omega-3 fatty acids and 2) aerobic exercise training. Omega-3 fatty acids can prevent the development of insulin resistance but have not been successful in reversing established insulin resistance. Importantly, omega-3 fatty acids are effective for improving the ratio of triglycerides to HDL-C in blood and reducing the amount of fat in the liver. Aerobic exercise has demonstrated greater success for reversing established insulin resistance, but it is not known if and to what degree supplementation with omega-3 fatty acids could potentiate its therapeutic efficacy and vice versa regarding dyslipidemia. Both omega-3 fatty acids and exercise lead to increased blood concentrations of beneficial oxygenated lipid compounds (termed oxylipins) that regulate inflammatory and metabolic processes (including insulin resistance) linked to the development of NAFL.

In preparation for studies of people in poorer metabolic health, the investigators will conduct a pilot and feasibility study of relatively inactive younger adults with low dietary intake of omega-3 fatty acids to assess whether increased aerobic physical activity combined with omega-3 supplementation leads to greater improvements in blood concentrations of triglycerides, HDL-C, and their ratio, as well as concentrations of oxylipins in the blood. The investigators will also assess whether a less studied omega-3 fatty acid, called DPA, may have effects above and beyond those conferred by EPA and DHA (which are concentrated in prescription omega-3 fatty acid products).

详细描述

This is a double-blind, randomized, placebo-controlled clinical study. The treatment phase will span a continuous 6-week period. Prior to the treatment phase, participants will be assigned to receive the DPA enriched n-3 supplement, conventional n-3 supplement, or identical placebo. A computer program will be used to randomly assign participants to a treatment group.

Intervention protocol and study treatments:

Study capsules will be provided tri-weekly at the Food, Bioactives, & Health Lab on the University of Arizona campus. Participants may schedule pick-up times that are most suitable for their schedules. A staff member will be available to meet with participants at each tri-weekly pick-up appointment.

The treatments are as follows:

  • 4 g/d DPA enriched n-3 concentrate (~980 mg DPA, 380 mg EPA, 1720 mg DHA)
  • 4 g/d n-3 control (~980 oleic acid, 380 mg EPA, 1720 mg DHA)
  • 4 g/d placebo control ("light" olive oil)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Light to moderate activity level
  • BMI of 18-29 kg/m2
  • Consistent dosage for any medication/supplements taken for inflammatory conditions
  • Ability to abstain from alcohol for 48 hours prior to lab testing
  • Low fish consumption (<2 serving/week), no use of omega-3 or fish oil supplements

排除标准

  • Pregnant or lactating
  • Use of medications for blood thinning, elevated lipids, blood pressure, or glucose
  • Allergy to fish
  • Any condition for which exercise is contraindicated
  • Intolerance to physical training

结局指标

主要结局

Triglyceride/HDL-C ratio

时间窗: 6 weeks

Triglyceride/HDL-C ratio

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ann Skulas-Ray

Assistant Professor

University of Arizona

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