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临床试验/ISRCTN19301859
ISRCTN19301859已完成未知

Efficacy study of a food supplement based on arabinoxylans obtained from barley on the reduction of postprandial glycemic response in healthy subjects: a monocentric, randomized, cross-over, double-blind, placebo-controlled clinical trial

HEALLO s.r.l.0 个研究点目标入组 40 人开始时间: 2022年3月22日最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
40

研究概览

简要总结

2022 Results article in https://doi.org/10.3390/nu14193916 (added 18/10/2022)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Healthy subjects, according to what was determined by the clinical history and by the information provided during the recruitment
  • 2. Aged between 18 and 65 years
  • 3. Non-smokers
  • 4. Subjects able to understand and to sign the Informed Consent

排除标准

  • 1. Subjects with type 1 or 2 diabetes
  • 2. Subjects with fasting blood glucose >110 mg/dl
  • 3. Subjects with blood pressure values >160/100 mmHg
  • 4. Subjects with metabolic disorders
  • 5. Subjects with endocrine, cardiovascular, pulmonary, renal or gastrointestinal diseases, which may interfere with the results of the study
  • 6. Subjects with sensitivity, intolerance or allergy to products used in the clinical trial
  • 7. Pregnant or lactating women
  • 8. Subjects who have donated blood in the 3 months prior to recruitment
  • 9. Subjects under pharmacological treatment, with drugs that could interfere with the study, such as alpha-glucosidase inhibitors (acarbose etc), insulin-sensitive drugs (metformin etc), sulfanilureee, cholesterol medications, and any other medications that the physician does not deem compatible with the study
  • 10.Subjects who were taking food supplements that could interfere with the study, such as products high in vitamins and minerals (>200% VNR), B vitamins, C vitamin, calcium, zinc, copper, chromium, iodine, iron, magnesium, manganese, phosphorus, essential fatty acid products, botanicals, and any other products that the physician does not deem compatible with the study.

研究者

发起方
HEALLO s.r.l.

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