Acute Effects of a Combination Plant-Based Protein and Marine-Based Multi-Mineral Supplement on Postprandial Gut Hormones and Bone Remodeling in Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Bone turnover
研究概览
简要总结
Nutrient intake of calcium and protein are known to function as regulators of bone remodeling. Specifically, a balanced rate of bone resorption and bone formation (i.e. bone remodeling process) is required to maintain bone health. However, a high remodeling rate, or an imbalance between formation and resorption, as well as suboptimal nutrient intake are known to contribute to fracture risk and bone dysfunction.
Gut-derived hormones represent an important link between nutrient intake and bone remodeling (i.e. gut-bone axis). A sustainable nutritional intervention that positively modulates the postprandial responses of gut-derived hormones and the linked bone remodeling processes is an attractive option for the optimization of bone health in young adults.
The proposed nutrient intervention seeks to explore the bioefficacy of a combination plant-based protein and marine-based multi-mineral supplement following oral ingestion in young, healthy men and women. A postprandial time-course study will be undertaken to examine the acute effects and/or associations between different gut-derived hormones and biomarkers of bone metabolism.
详细描述
A block-randomized, within-subject, two-day, crossover design examining acute (0-4 hour) postprandial changes in different gut-derived hormone concentrations and biomarkers of bone metabolism in 12 healthy, young adults following ingestion of a combination plant-based protein and marine-based multi-mineral supplement or control.
Each participant will consume (in a random manner) either one of two investigational products (i.e., combined nutritional supplement or control). The combined nutritional supplement will consist of: 0.3 g/kg body mass of ATURA Fava-Bean Protein and 800mg of Aquamin F (a highly bioactive source of minerals rich in calcium) dissolved in 500ml water volume. The control product will consist of 500ml water volume without the protein and multi-mineral nutritional composition.
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 (Investigator)
盲法说明
Single Blind Study (Investigator only)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 18 to 35 years.
- •Recreationally active (150-300 min/week of moderate physical activity).
- •Healthy (i.e.,not presenting with injury, illness, medication, history of chronic disease, or known allergies/intolerance (e.g. favism) to the ingredients contained in either formulation.
排除标准
- 未提供
结局指标
主要结局
Bone turnover
时间窗: Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Plasma)
A balance of the difference between the magnitude and time course of the acute change (0-4 hours) in plasma C-terminal telopeptide of type 1 collagen (CTX) in ng/mL, a measure of bone resorption, and procollagen type 1 amino-terminal propeptide (P1NP) in ng/ml, a measure of bone formation.
次要结局
- Change in regulator of bone metabolism - Parathyroid hormone(Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Plasma))
- Change in insulin and glucose(Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Plasma))
- Vitamin D Status(Pre-ingestion (Plasma))
- Change in incretin peptides(Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Plasma))
- Change in ionized calcium and potassium.(Pre-ingestion and 15, 30, 45, 60, 90, 120, 180, 240 minutes Post-ingestion (Whole Blood))