Acute Effects of Dairy and Meat Proteins on Bone Metabolism and Metabolic Profile in Urine and Plasma in Overweight Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- urine C-terminal carboxy-terminal collagen
研究概览
简要总结
The purpose of this randomized, controlled, cross over single meal study is to investigate the metabolic effects of a breakfast rich in dairy proteins and to determine biomarkers for their intake. The results from this project will increase our knowledge about nutritional value of dairy proteins, which is necessary to decide whether dairy products can be recommended for prevention of weight related bone loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females between 18 and 50 years
- •BMI 25-40
排除标准
- •Physical activity more than 10 hours weekly
- •Diagnosed osteoporosis in at least one parent
- •Dietary supplements and vitamin pills (during the study and 2 months before the start)
- •Vegetarians and vegans
- •Lactose intolerant
- •Women who are pregnant, breastfeeding or post-menstrual
- •Regular intake of medication
- •Chronic diseases (including osteoporosis, cancer, diabetes, cardiovascular disease and mental disorders)
- •Participation in other clinical trials that could affect the test results
- •Donation of blod within 3 months before intervention start
- •Hypersensitivity to paraaminobenzoic acid (PABA)
- •Not able to comply with the procedures established by the Protocol
结局指标
主要结局
urine C-terminal carboxy-terminal collagen
时间窗: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
serum osteocalcin (sOC)
时间窗: at 0, 30, 60, 120, 180 and 240 min at both visits
serum tartrate-resistant acid phosphatase (s-TRAP)
时间窗: at 0, 30, 60, 120, 180 and 240 min at both visits
urine deoxypyridinoline crosslink (uDPD)
时间窗: baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
serum C-terminal carboxy-terminal collagen crosslinks (CTX)
时间窗: at 0, 30, 60, 120, 180 and 240 min at both visits
plasma metabolites for metabolomics analyses
时间窗: at 0, 30, 60, 120, 180 and 240 min at both visits
urine metabolites for metabolomics analyses
时间窗: baseline 24-h urine samples, 24-h urine samples after the meal test, urine samples at 2-h and 4-h after the meal test and urine samples from 4-h to 24-h, all at both visits
次要结局
- serum insulin-growth factor-1 (IGF-1)(at 0, 30, 60, 120, 180 and 240 min at both visits)
- serum insulin-growth factor binding-protein-3 (IGFBP-3)(at 0, 30, 60, 120, 180 and 240 min at both visits)
- serum insulin(at 0, 30, 60, 120, 180 and 240 min at both visits)
- serum glucose(at 0, 30, 60, 120, 180 and 240 min at both visits)
- serum glukagon-like peptide-1 (GLP-1)(at 0, 30, 60, 120, 180 and 240 min at both visits)
- urinary PABA(baseline 24-h urine samples and 24-h urine samples after the meal test at both visits)
- urinary creatinin(baseline 24-h urine samples and 24-h urine samples after the meal test at both visits)
- urinary biobank(baseline 24-h urine samples and 24-h urine samples after the meal test at both visits)
- plasma biobank(at 0, 30, 60, 90, 120, 180 and 240 min at both visits)
研究者
AAstrup
Dr Med Sci
University of Copenhagen