Randomized, Double-blind, Placebo-controlled Intervention Study on Effects of Basica® on Acid-base Balance, Metabolism and Quality of Life in Elderly Healthy Volunteers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Change in muscle dialysate lactate-pyruvate ratio
研究概览
简要总结
Metabolism is controlled by macro- and micronutrients. Protein-rich diets should lead to latent acidosis at tissue level with further negative implications. Food supplements with alkaline salts are available and popular pretending to prevent these changes.
Within a randomized double-blind placebo-controlled trial, the investigators tested the hypotheses 1) that a 4-week protein-rich diet induces a latent tissue acidosis and 2) an alkaline supplement can compensate this. Acid-base balance and important metabolic parameters were determined before and after 4 weeks of supplementation by peripheral blood samples, indirect calorimetry and muscle microdialysis before and after a protein-rich test meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •slightly reduced kidney function (GFR 60-89 ml/min)
- •Body mass index 20.0 - 29.9 kg/m2
- •normal daily diet composition: 45-50, 35-40, and 15 E% from carbs, fats and proteins, respectively
排除标准
- •sorbitol-/fructose-intolerance
- •intake of antacidic drugs
- •vegetarians, vegans
- •intake of any nutritional supplements
- •any cardiovascular, pulmonary, endocrine or metabolic diseases
- •any drug abuse
- •intake of any anticoagulant drugs
结局指标
主要结局
Change in muscle dialysate lactate-pyruvate ratio
时间窗: before and after 4-weeks of supplementation at baseline (after a 12 hours overnight fast) and 60, 120, and 180 minutes after a protein-enriched test meal
surrogate measure for muscle tissue pH
次要结局
未报告次要终点
研究者
Michael Boschmann
Principal Investigator
Charite University, Berlin, Germany