Testing the Effect of a Plant-based, Protein-dense Sauce (ProSauce) on Metabolic Availability of Essential Amino Acids and Gut Fullness and Satiety in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Concentrations of essential amino acids
研究概览
简要总结
The goal of this clinical trial is to determine whether meals fortified with plant-based high protein sauce (ProSauce) provide better metabolic availability of essential amino acids compared to meals with standard lower-protein sauce without resulting in excessive gut fullness and satiety. The main questions it aims to answer are:
Does meals with high-protein sauce deliver better metabolic availability of amino acid profile? Does this high-protein sauce also not lead to excessive appetite suppression due to its liquid form? Researchers will compare high protein sauce to a commercially available standard low protein sauce.
Participants will consume two meals, either protein-fortified or standard low-protein sauce, in a randomised order with at least a one-week washout period between each meal. The investigators will collect venous blood samples over a 6-hour postprandial period to measure plasma essential (and non-essential) amino acid and insulin concentrations. The investigators will also measure appetite-related hormones from venous plasma and assess subjective appetite using a visual analogue scale, taken in parallel with the blood sample time points.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 60 and over
- •Living independently in the community
- •Capacity to provide informed consent
- •Non-smoking (vaping is considered smoking)
- •No known medical conditions that might influence the study outcomes, e.g., heart disease, diabetes mellitus, obesity, disthyroidism and other endocrinopathies and renal failure
- •Not taking any medications that might influence the study outcomes e.g., taking anabolic steroids or corticosteroids long term
- •No clinically diagnosed eating disorders
- •No severe dislike or allergy to any of the study food
- •No hospitalisations in the last 6 months
- •Not dieting and weight stable for 3 months before the study (< 3 kg change in weight)
排除标准
- •Age < 60y
- •Food allergies
- •Cognitive and mobility issues
- •Hospitalisation in the last 6 months
- •Known medical conditions that might influence the study outcomes
- •Taking medications that influence the study outcomes
研究组 & 干预措施
standard sauce
干预措施: low-protein sauce (Dietary Supplement)
ProSauce
干预措施: ProSauce (Dietary Supplement)
结局指标
主要结局
Concentrations of essential amino acids
时间窗: Essential amino acid concentrations at time points of baseline, immediately after breakfast (t =0 minute) and t = 20, 40, 60, 90, 120, 180, 240, 300, 360 minutes.
Baseline and postprandial plasma amino acid concentrations will be measured to provides valuable insights into protein digestion and absorption.
次要结局
- Concentrations of appetite-related gut hormones(Appetite-related gut hormones will be measured at time points of baseline, immediately after breakfast (t =0 minute) and t = 20, 40, 60, 90, 120, 150, 180, 210, 240 minutes.)