ISRCTN15697400已完成Unknown
Efficacy study of the food supplement based on Moradyn® (purple corn variety extract Zea mays L.), Gymnema, Zinc, and Chromium, commercial name GLIKUR Advance” for the maintenance of normal carbohydrate metabolism through the reduction of slightly altered plasma glucose levels, as cardiovascular risk factors: single-center, controlled, randomized, parallel-group, double-blind clinical study.
ational Inter-university Consortium of Research in Innovative Pharmaceutical Technologies - Tefarco Innova0 个研究点目标入组 81 人开始时间: 2024年2月16日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 81
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
- 性别
- All
入选标准
- •1. Aged 18-75 years old of both sexes
- •2. Able to understand and sign the informed consent
- •3. 98 mg/dL < impaired fasting glycemia < 125 mg/d
排除标准
- •1. Aged < 18 and > 75 years old
- •2. A medical history or condition that could affect the subject's safety or negatively impact the validity of the study results
- •3. Pregnant or breastfeeding women
- •4. With a history of allergy to ingredients contained in the study treatments (dietary supplement and placebo)
- •5. Exposed to a high risk of cardiovascular events based on 8 risk factors (sex, age, diabetes, smoking habits, systolic blood pressure, total cholesterolemia, hdl-cholesterolemia and antihypertensive treatment)
- •6. Following drug therapy for diabetes even at low dosages
- •7. Taking supplements to control cholesterol, blood sugar and metabolic syndrome, in the two weeks prior to recruitment
- •8. Women who suspect pregnant or planning pregnancy
- •9. Blood donors in the three months prior to recruitment
- •10. Non-self-sufficient individuals
- •11. Who does not show a propensity to collaborate
- •12. Who have difficulty getting to the reference facility within the scheduled time
- •13. Who are not considered suitable by the investigators due to the presence of other pathologies considered incompatible with enrollment.
研究者
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