NL-OMON53253尚未招募不适用
Assessment of Mass Balance of Orally Administered [14C] Tagatose in Healthy Volunteers Using a Microtracer Approach - TrueCal
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 8
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
- 年龄范围
- 18 至 64（—）
入选标准
- •- 18-65 years old healthy female and male using contraception during and for 3
- •months after the study
- •- BMI 18.5-25 kg/m2
- •- Must be willing and able to communicate and participate in the whole study,
- •including consumption of tagatose and meals offered during study conduct
- •- Must have regular bowel movements (i.e. average stool production of >=1 and <=3
- •stools per day)Must usually eat 3 meals per day (i.e. breakfast, lunch and
排除标准
- •- Diabetes (Type 1, Type 2, or genetic form of diabetes) - Any diagnosed
- •cardiovascular (heart) disease or high blood pressure (>=140 mmHg systolic
- •and/or >=90 mmHg diastolic) - History of clinically significant cardiovascular,
- •renal, hepatic, chronic respiratory or gastro-intestinal disease,
- •immunodeficiency, endocrine, neurological or psychiatric disorders - Any
- •diagnosed respiratory disease, such as COPD or asthma - Any previous motor
- •disorders or disorders in muscle and/or lipid metabolism - Known severe kidney
- •problems - Presence of an ulcer in the stomach or gut and/or strong history of
- •indigestion - Recent or chronic history of diarrhoea - Known anaemia - A
- •personal or family history of thrombosis (clots), epilepsy, seizures, or
- •schizophrenia. - Regular use of dietary supplements (>3 times per week) -
- •Chronic use of any prescribed or over the counter pharmaceuticals (excluding
- •oral contraceptives and contraceptive devices)History of any drug or alcohol
- •abuse in the past two years - A confirmed positive alcohol breath test at
- •screening or admission - Drug use - Claustrophobia - Subjects who are on a
- •weight loss diet or following a high calorific/high protein diet in order to
- •gain weight - Subjects with functional constipation - Any known food allergies
- •or intolerances to the 14 major food allergens (celery, cereals containing
- •gluten, crustaceans, eggs, fish, lupin, milk, molluscs, mustard, tree nuts,
- •peanuts, sesame seeds, soybeans, sulphur dioxide and sulphites) or history of a
- •malabsorption syndrome including coeliac disease - Subjects who have regular
- •gastrointestinal complaints including abdominal pain, stomach upsets and
- •borborygmi or known or suspected irritable bowel syndrome - Currently taking
- •part in other scientific research - Having received a product with 14C in the
- •past 12 months - Pregnant or breastfeeding - Smoking or having used
- •nicotin-containing products in the 6 months prior to the study. - Subjects who
- •have taken antibiotics within the 60 days prior to the adaptation period. -
- •Currently involved in a structured progressive resistance training programme
- •(>3 times per week) - Sedentary lifestyle as assessed using the International
- •Physical Activity Questionnaire [IPAQ]. - Employed or undertaking a thesis or
- •internship at the department of Human and Animal Physiology - Unable to give
研究者
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