NCT05199948进行中（未招募）不适用
Weight, Energy, Lipids, and the Liver (WELL) Study: Dietary Fat Quality and Ectopic Lipids in the Liver
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Changes in ectopic liver lipids
研究概览
简要总结
The research study is a parallel arm, randomized placebo-controlled clinical trial designed to assess changes in hepatic lipid accumulation, visceral adipose tissue and postprandial lipid, markers of inflammation and energy metabolism in participants who consume 3 study foods per day for 16 week, while maintaining their body weight.
详细描述
The study objectives include:
- To determine the impact of dietary soybean oil on ectopic liver fat and visceral adipose in adults with nonalcoholic fatty liver disease (NAFLD) or similar diagnosis
- To evaluate the effect of soybean oil supplementation on postprandial lipids, markers of inflammation and energy metabolism
- To measure the strength of the association of change in plasma linoleic acid with changes in ectopic liver fat, visceral adipose, and postprandial lipids, markers of inflammation and energy metabolism
- To explore emerging mechanistic targets of LA-rich soybean oils that are linked with reduced liver fat and better cardiometabolic health
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nonalcoholic fatty liver disease (NAFLD), Nonalcoholic Steatohepatitis (NASH) or similar
- •Body Mass Index of 20-55 kg/m2
排除标准
- •Unstable management of heart failure, heart disease events within 3 months, a need for heart surgeries or procedures, and/or the use of a pacemaker or defibrillator
- •Current or previous diagnosis of severe kidney failure or diseases, some liver and pulmonary diseases
- •Severe or uncontrolled circulatory diseases and autoimmune diseases
- •Current diagnosis of or current treatment of cancer other than non-melanoma skin cancer
- •Current or previous diagnosis of type 1 diabetes
- •Use of Vitamin E supplements or Actos and Glucagon-like Peptide-1 medications for less than 1 months prior to enrolling.
- •Gastrointestinal diseases or disorders (including pancreatic and gastric bypass surgery) that would prevent participants from tolerating the study foods
- •Food Allergy or intolerances
- •Any dietary restriction where consumption of the study foods, study meals/snack or meal challenge or any ingredient would be contraindicated
- •Use of medications where consuming the food products would be contraindicated
- •Use of supplements high in linoleic acid in the past 4 weeks prior to enrolling
- •Hyperthyroidism
- •Pregnancy and lactation
- •Alcohol or drug abuse
- •Inability to access veins for venipuncture
- •Claustrophobia
- •Metal implants or metallic foreign objects in the body
研究组 & 干预措施
Soybean Oil
Experimental
Consumption of study foods each day made with soybean oil
干预措施: Soybean Oil Foods (Other)
Palm Oil
Placebo Comparator
Consumption of study foods each day made with palm oil
干预措施: Palm Oil Foods (Other)
结局指标
主要结局
Changes in ectopic liver lipids
时间窗: Week 0 and Week 16
To determine the impact of dietary soybean oil on ectopic liver fat measured through MRI
次要结局
- Changes in visceral adipose tissue(Week 0 and Week 16)
- Changes in postprandial lipids(Week 0 and Week 16)
- Changes in postprandial markers of inflammation(Week 0 and Week 16)
- Changes in postprandial energy metabolism(Week 0 and Week 16)
研究者
Martha Belury
Associate Professor
Ohio State University
研究点 (2)
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