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临床试验/CTRI/2013/04/003527
CTRI/2013/04/003527已完成4 期

A Prospective, Open Label study to evaluate the Effect of standardized wheat flakesbreakfast provided within an energy restricted diet plan along with a controlledphysical activity regimen, on weight loss among overweight subjects. - Nil

Spectrum Clinical Research PvtLtd0 个研究点目标入组 70 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
70

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

入选标准

  • 1. BMI is greater than or equal to 23 and less than or equal to 30 at study entry
  • 2. Not Allergic to milk or wheat
  • 3. Not enrolled in the gym
  • 4. For females only: without childbearing potential or negative HCG hormone blood test
  • and use of an appropriate form of contraception
  • 5. Willing to take the wheat flakes as prescribed and sign an inform consent document
  • for participation in the study

排除标准

  • 1. Illness e.g. diabetes, hypertension or cholesterol problems etc. / thyroid problems
  • 2. Participants on Medication/ special diets for weight loss
  • 3. Gastrointestinal disorders that might cause complications or influence motility or satiety.
  • 4. Fasting serum glucose > 126 mg/dL.
  • 5. Conditions for which weight loss may not be appropriate (e.g., HIV/AIDS, cancer)
  • 6. Use of medications that might affect weight or food absorption (e.g., diuretics,glucocorticoids, laxatives).
  • 7. Alcohol consumption more than 20ml /day.
  • 8. Currently smokes cigarettes due to the effects of nicotine on appetite
  • 9. Pregnant and lactating women
  • 10. Athletes or patients who do exercises every day
  • 11. Patients suffering from Mal-Absorption Syndrome
  • 12. Patients who are unlikely to comply with Protocol requirements e.g. uncooperative
  • attitude, patients who are frequent travelers, inability to return for follow up visits
  • 13. Patient participating in any other clinical trial

研究者

发起方
Spectrum Clinical Research PvtLtd

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