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临床试验/TCTR20221221002
TCTR20221221002Unknown3 期

Development of medical food products for patients with and without diabetes mellitus using whole milk or lactose-free milk plus rice as the main ingredients to replace imported products

Agricultural Research Development Agency (ARDA)0 个研究点目标入组 20 人开始时间: 2022年12月21日最近更新:
适应症

试验速览

阶段
3 期
发起方
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 Years 至 60 Years(—)
性别
All

入选标准

  • 1. age 18 years and older
  • 2. fasting plasma glucose < 100mg/dL
  • 3. no prior history of diabetes and no prior treatment with glucose-lowering drugs
  • 4. no history of food allergy
  • 5. participants taking aspirin, birth control pills, vitamins and supplements, anti-hypertensive drugs, osteoporosis drugs at stable doses for 1 month or more are eligible for study inclusion

排除标准

  • 1. significant medical problems requiring ongoing treatment, including but not limited to cancer, cardiac,
  • pulmonary, hepatic, brain diseases or severe infection within 1 year before study inclusion
  • 2. surgery or hospital admission within 3 months before study inclusion
  • 3. history of allergy to medical food and lactose (or one or more of its components) used in the current study
  • 4. pregnancy and lactation
  • 5. use of thyroid hormones
  • 6. history of diabetes or previous use of glucose-lowering drugs or insulin
  • 7. diagnosis of diseases which significantly affect food digestion and absorption such as inflammatory bowel
  • disease, Crohn's disease, ulcerative colitis
  • 8. treatment with medications which can affect blood glucose levels, such as steroids, protease inhibitors,
  • and antipsychotic drugs

研究者

发起方
Agricultural Research Development Agency (ARDA)

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