ISRCTN73005547已完成不适用
Study of the beneficial effects of a combination of food ingredients on cardiovascular risk factors in overweight subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KitoZyme
- 入组人数
- 100
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. Male and female
- •2. Aged at least 18 years
- •3. Caucasian type
- •4. 255. Stable patient’s weight ± 5% for at least 3 last months and patient’s agreement not to change food habits during the study
- •6. Menopausal women without or with HRT with a stable rate for at least 3 months
- •7. Able to understand and to give consent
- •8. Compliant with treatment
排除标准
- •1. Current cancer treatment
- •2. Diabetes
- •3. Severe intestinal problems
- •4. Autoimmune or chronic inflammatory diseases
- •5. Unintentional weight loss (> 10% of body weight) during the previous 6 months
- •6. Particular nutritional practice (vegetarians, vegans, high consumption of fiber)
- •7. Intake of food supplements
- •8. History of eating disorders (anorexia, bulimia)
- •9. Dieting at the time of inclusion
- •10. Underwent bariatric surgery
- •11. Consumption in the preceding 6 weeks of antibiotics or probiotics
- •12. Pregnancy, breastfeeding
- •13. Active smoker or ex-smoker for less than 2 years
- •14. Food allergy to one of the components of the supplement
- •15. Participation in another clinical study at the time of inclusion
- •16. Usually taking medication: anti-inflammatory drugs, corticosteroids, antiepileptics, neuroleptics, laxatives, antibiotics
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