DRKS00015821已完成2 期
Effect of a proprietary potato protease inhibitor on satiety, cholecystokinin concentration, weight loss and cognitive status in overweight individuals with increased waist circumference. - /
Herbalife Nutrition0 个研究点目标入组 52 人开始时间: 2018年11月19日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 25 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Age 25 - 55 years, women or men.
- •Negative pregnancy test. Surgical sterilization, menopause for at least 6 months or contraception by spiral or hormones.
- •BMI 25 - 40 kg/m² and waist circumference women > 80 cm, men > 94 cm
- •Health, determined by anamnesis, clinical examination and laboratory tests (blood count, Na, K, Ca, urea, creatinine, uric acid, ALT, AST, AP, GT, bilirubin, basal TSH, triglycerides, total cholesterol, HDL cholesterol, blood sugar, serum insulin, HbA1c and urine status).
- •Stable body weight in the last 3 months (fluctuation <2%).
- •Willingness to complete visual analogue scale (VAS) four times on 5 days and at test meals.
- •Willingness to prepare a diet protocol 4 times on 3 days.
- •Willingness to take blood samples before and after a test meal both at the beginning of the study and after 10 weeks.
- •To have been informed that normal care is provided even if participation in the study is not desired.
- •Tolerance of the test meal.
- •Written consent to participate in the study
排除标准
- •BMI > 40 kg/m². Body weight fluctuations of > 2% in the last month.
- •Estimated energy requirement / day < 1500 kcal
- •Adherence to a diet with < 800 Kcal/d longer than 4 months in the last 12 months. Weight loss of > 10 kg in the last 6 months.
- •Surgical measures due to obesity.
- •Diabetes mellitus, CVD, kidney or liver disease, psychiatric diseases.
- •Abnormal laboratory parameters (serum creatinine, ALT, AST, bilirubin, TSH, triglycerides > 5.0 mol/l, cholesterol > 9.0 mmol/l).
- •Desire to have children, breastfeeding mothers.
- •Taking medication for weight loss or medication for diseases whose course cannot yet be estimated.
- •Smokers, alcohol consumption > 2 drinks/day
- •Allergies to potatoes, Panax ginseng or roseroot. Drug and medication abuse
- •hypothyroidism that is not already treated with thyroid hormone
- •Patients with pacemakers, metal plates, piercing that cannot be removed. Taking test substances in the last 8 weeks. Intolerance of the test meal.
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