Effect of Soy Intake on Cardiovascular Disease Biomarkers in Subclinical Hypothyroid Participants
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Changes in the cardiometabolic profile
研究概览
简要总结
The purpose of this study is to help the researchers understand if using a soy supplement impacts cardiovascular disease risk factors in patients with subclinical hypothyroidism.
详细描述
This pilot trial is a double blind, randomized, parallel arm trial. Eighty participants with subclinical hypothyroidism will be randomized to consume either soy protein isolate or milk protein isolate for 8 weeks.
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
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with subclinical hypothyroidism (otherwise healthy volunteers)
- •Adults aged 25 - 70 yrs.
- •Willing to avoid consumption of soy/other isoflavone containing foods (i.e. some snack bars) during the study.
- •Willing to avoid consumption of dietary (other than multivitamin) and herbal supplements during the study.
排除标准
- •Taking drugs that interfere with thyroid function
- •Planning pregnancy in the next 6 months
- •Taking drugs that lower lipids, blood pressure, or sensitize insulin
- •Regular consumption of soy products (>20 g/wk)
- •Consumption of soyfoods within 90 days prior to enrollment.
- •Known history of soy or milk allergy or intolerance.
- •Taking antibiotics during the intervention
- •Active viral infections such as Human immunodeficiency virus (HIV) positive or hepatitis
研究组 & 干预措施
soy protein isolate (SPI)
25 grams soy protein isolate (SPI) containing approximately 30 mg/d isoflavones
干预措施: soy protein isolate (SPI) (Dietary Supplement)
milk protein isolate (MPI)
milk protein isolate (MPI) containing 0 mg/d isoflavones
干预措施: milk protein isolate (MPI) (Dietary Supplement)
结局指标
主要结局
Changes in the cardiometabolic profile
时间窗: Change from Baseline to Week 8
Evaluate the role of isoflavone intake on cardiovascular disease.
次要结局
- Change in thyroid function(Change from Basesline to 4 Weeks)
- Changes in the cardiometabolic profile(Change from Basesline to 4 Weeks)
- Change in thyroid function(Change from Basesline to 8 Weeks)
研究者
Jill Hamilton-Reeves, PhD RD LD
Assistant Professor
University of Kansas Medical Center