NCT05348304已完成不适用
Hypoglycemic Effects of a Dietary Supplement That Combines the Properties of Myo-inositol and D-chiro-inositol With Gymnema Silvestre, Alpha-lactalbumin and Zinc.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Insulinemia
研究概览
简要总结
This study is aimed at evaluating the hypoglycemic effects of a dietary supplement that associates the properties of two inositols (myo-inositol and D-chiro-inositol) in the ratio 40:1 to Gymnema sylvestre, alpha-lactalbumin and zinc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI between 30 and 35
- •Basal Glycemia between 100 and 125 mg/dl
排除标准
- •Diabetes diagnosis
- •Use of food supplements containing inositols, gymnema, alpha-lactalbumin and zinc
- •Intolerance to inositols, gymnema, alpha-lactalbumin and zinc
研究组 & 干预措施
Control
No Intervention
Hypocaloric diet
EUDIAMET
Experimental
Hypocaloric diet plus a supplementation with myo-inositol and D-chiro-inositol in the 40:1 ratio, Gymnema sylvestre, alpha-lactalbumin and zinc
干预措施: EUDIAMET (Dietary Supplement)
结局指标
主要结局
Insulinemia
时间窗: Three time points: change in insulin levels from the baseline to three and six months
Reduction of systemic insulin levels
次要结局
未报告次要终点
研究者
研究点 (1)
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