NCT03444233已完成4 期
Impact of Short-term Fructose-enriched Diet on Serum Metabolome by Normal- and Over-weighed Women.
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- metabolite concentration
研究概览
简要总结
The purpose of this study is to investigate how a high-fructose diet, either by high fructose intake from complex, natural foods or by fortifying the diet with corn syrup, affects the metabolism. Furthermore, it will be investigate if there are differences between obese and normal weight participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy adults, aged between 20 and 30 years
- •normal weighted (BMI ≤ 25 kg/m2) and obese (BMI 35-50 kg/m2)
- •written informed consent
- •At initial medical examination an anamnesis, physical examination, blood sample collection (10 ml) was performed to check for eligibility. Furthermore, a hydrogen breath test was performed to detect potential fructose intolerance
排除标准
- •fructose intolerance/ -malabsorption,
- •pregnancy
- •chronic gastrointestinal diseases (e.g. chronic inflammatory bowel disease, irritable bowel syndrome, celiac disease etc.),
- •operation on the gastrointestinal tract (exclusively appendectomy)
- •hepatic or renal disease
- •diabetes mellitus
- •consuming illnesses (e.g. cancer, acquired immunodeficiency syndrome (AIDS)) - drug intake affecting lipid or glucose metabolism (cholesterol- or glucose reducing or antihypertensive drugs, steroids, L-Thyroxin, antidepressants, weight reducing drugs).
研究组 & 干预措施
low f1 diet
Experimental
low fructose diet week 1
干预措施: Diet (Other)
fruit rich diet
Experimental
fruit rich diet week 2
干预措施: Diet (Other)
low f2 diet
Experimental
low fructose diet week 3
干预措施: Diet (Other)
HFCS rich diet
Experimental
HFCS rich diet week 4
干预措施: Diet (Other)
结局指标
主要结局
metabolite concentration
时间窗: Participants will be followed for the time of four weeks.
The primary endpoint is the change of metabolite concentration after low fructose diet week 1, fruit rich diet, low fructose diet week 3 and HFCS rich diet.
次要结局
- fatty liver index(Participants will be followed for the time of four weeks.)
- Non-alcoholic fatty liver disease (NAFLD)(Participants will be followed for the time of four weeks.)
- Body weight(Participants will be followed for the time of four weeks.)
- Blood pressure (systolic and diastolic)(Participants will be followed for the time of four weeks.)
- GGT(Participants will be followed for the time of four weeks.)
- GOT(Participants will be followed for the time of four weeks.)
- GPT(Participants will be followed for the time of four weeks.)
- AP(Participants will be followed for the time of four weeks.)
- Triglycerides(Participants will be followed for the time of four weeks.)
- HDL(Participants will be followed for the time of four weeks.)
- LDL(Participants will be followed for the time of four weeks.)
- Fasting glucose(Participants will be followed for the time of four weeks.)
- BSR(Participants will be followed for the time of four weeks.)
- Kreatinine(Participants will be followed for the time of four weeks.)
- Uric acid(Participants will be followed for the time of four weeks.)
- Urea(Participants will be followed for the time of four weeks.)
- Cholesterol(Participants will be followed for the time of four weeks.)
- Ghrelin(Participants will be followed for the time of four weeks.)
- Leptin(Participants will be followed for the time of four weeks.)
研究者
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