A Single-blinded, Placebo-controlled, Three-way Crossover Pilot Study, to Assess the Rehydrating Effect of a Nutritional Preparation Containing Gum Acacia Combined With Sea Magnesium After Exercise-induced Dehydration
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Nexira
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Fluid retention (%)
研究概览
简要总结
This clinical study is a single-blind, placebo-controlled, three-way cross-over trial evaluating the rehydration efficacy of two nutritional beverages compared to water, after one administration. The investigational products are gum acacia alone, and combined with sea electrolytes as magnesium. Participants, physically active men undergo exercise-induced dehydration followed by controlled rehydration procedure with each product in randomized sequence. The study includes standardized preconditions (diet, hydration, activity control), exercise and rehydration protocols.
Gam acacia has the benefit of few preclinic studies in murin models showing significant improvements on electrolytes and water absorption, but its effect on hydration in human has never been evaluated.
The combination with sea electrolytes has been developed to optimise and reduce the total concentration of electrolytes into the beverage compared to standard formulations proposed for rehydration in sport application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Sponsor and Biostatistician
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI 18-25
- •Regular physical training on a recreational level
- •Resting pulse rate <100; resting blood pressure <140 mmHg/<100 mmHg
排除标准
- •Participant suffering from acute or recently occurred (in the past 2 weeks) sickness e.g. common cold or gastrointestinal problems
- •Injuries that would limit exercise performance
- •History or presence of cardiovascular, metabolic, endocrine musculoskeletal, autoimmune or renal condition/disorder which per investigator's judgement could interfere with the results of the study or the safety of the participant
研究组 & 干预措施
Water
Provided to the participants in a blinded manner
干预措施: Rehydration beverage (Dietary Supplement)
结局指标
主要结局
Fluid retention (%)
时间窗: At rehydration phase directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes
Percentage of fluid retained from start of rehydration phase (weight of beverage intake ; cumulative urine weight)
次要结局
- Urine Specific Gravity (USG)(Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes)
- Net fluid balance (ml)(Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes)
- Beverage Hydration Index (BHI)(At rehydration phase directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes)
- Bioelectrical impedance vector analysis (BIVA, L)(At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes)
- Urine osmolality (mosmol/kg)(Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes)
- Urine volume (mL)(Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes)
- Electrolytes in urine (mmol/L or mg/ml)(At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes)
- Electrolytes in blood (mmol/L or mg/ml)(Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes)
- Blood Haemoglobin (g/dL)(Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes)
- Blood Haematocrit (%)(Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes)
- Plasma volume (%)(Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes)
- Change in body weight (kg)(At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes)
- Body mass restored (%)(At rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes)
- Thirst perception (VAS)(Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes)
- Gastro-Intetsainl symptoms (VAS)(Before exercise / at rehydration phase before and directly after beverage intake (T0) / at 60 minutes / at 120 minutes / at 180 minutes / at 240 minutes)
- Global evaluation of tolerability (4 scales ; very good to poor)(At 240 minutes)