The Effects of a Commercially Available High Protein Spoonable on Amino Acid Bioavailability in 18-45-year-old Male and Female Volunteers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Peak Concentration for Total Amino Acids
研究概览
简要总结
The key research objective is to characterise the amino acid (AA) bioavailability for 4 hours following consumption of a single serving of a high protein spoonable yoghurt, compared to a micellar casein drink or a flavoured water-based placebo jelly, in 18-45-year-old males and females. An additional exploratory objective is to characterise the time to reach peak concentration (Tmax) of AA after consumption of a single serving of each product.
详细描述
This study is a single-blind, three-way, randomised crossover design. It involves four visits to the laboratory in total; the first session will be a pre-screening and familiarisation, and the subsequent three sessions will be 3 x bioavailability assessments, separated by a washout period of a minimum of 5 days and maximum of 21 days. The bioavailability assessments will be identical except for the product consumed; subjects will receive one serving of the following in a random order:
- Test product: High protein spoonable yoghurt (1 serving = 45 g protein comprising 3 yoghurt pots totalling 480 g) (Danone Nutricia).
- Control product 1: Micellar casein drink (1 serving = 45 g protein/480 g).
- Control product 2: flavoured water-based placebo jelly (1 serving = 0 g protein comprising 3 jelly pots totalling 480 g).
A follow-up communication via telephone will be conducted within 7 days of completion of the fourth and final session to ensure there are no adverse effects of participation.
A detailed overview of the research activity that will take place in each session is provided below:
Visit 1: Pre-screening: Volunteers will receive information on the study, and they will be familiarised with the requirements for participation and provide written informed consent. Subjects will be requested to complete 3-day food and exercise diaries, comprising of 1 weekend day, 1 rest day, and 1 exercise day within a week of the trial. This will be handed in on Visit 2. Subjects' body height, body mass, body composition, and body mass index (BMI) will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Single-Blinded
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 and ≤ 45 years
- •Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
- •Written informed consent
- •Willingness and ability to comply with the protocol in the opinion of the Investigator
- •Judged by the Investigator to be in good health as assessed by a health screening questionnaire
- •Currently identifies as the same biological sex as at birth
排除标准
- •Any known ongoing medical condition that interferes significantly with absorption and digestion and/or gastrointestinal (GI) function (e.g. inflammatory bowel disease, gastroesophageal reflux disease, celiac disease, diaphragmatic hernia or diaphragmatic surgery, gastric ulcer, gastritis, gall bladder problems, pancreatitis, GI cancer, oesophageal and/or gastric surgery), in opinion of the investigator.
- •Known musculoskeletal or soft tissue injury
- •Known cardiovascular disease, disease related to the immune system and/or the respiratory system
- •Known renal or hepatic failure or known thyroid dysfunction
- •Known Diabetes Mellitus type I or type II, insulin resistance or metabolic syndrome
- •Any ongoing cancer (except for basal cell carcinoma) and/ or cancer treatment
- •Known anaemia or low haemoglobin or low iron status
- •Any known bleeding disorder or reaction to withdrawal of blood samples
- •Use of oral and systemic use of prokinetics, laxatives, antidiarrheals, anticoagulants within 2 weeks prior to screening
- •Use of systemic antibiotics within 4 weeks prior to screening
- •Any known allergies or intolerances to ingredients of the study product, i.e. cow's milk allergies, lactose intolerance
- •Adherence to a strict dietary regime (e.g. vegetarian/ vegan/ paleo/ketogenic/intermittent fasting/ high protein diet (>1.6 g/kg body weight/day) or a weight loss program)
- •Use of any nutritional supplements or additional protein supplements or nutritional support within 4 weeks prior to screening
- •Falling below or exceeding the classification of Tier 1 or Tier 2 (McKay et al 2022, IJSPP. 17, 317-331). Ranging from minimum of meeting WHO guidelines for physical activity up to training ~3 times per week and local level representation in a sport.
- •Known pregnancy and/or lactation
- •Current smoking or stopped smoking for <1 month prior to screening (except for incidental smoking of ≤3 cigarettes/cigars/pipes per week on average in the last month)
- •Average alcohol use of >21 glasses* per week for men or >14 glasses per week for women (on average during the last 6 months) or drug/ medicine abuse in opinion of the investigator
- •Participation in any other clinical study with investigational or marketed products concomitantly or within 4 weeks before screening.
- •Major medical or surgical event requiring hospitalization within the preceding 3 months and/or scheduled in the period of study participation relevant in the opinion of the Investigator
结局指标
主要结局
Peak Concentration for Total Amino Acids
时间窗: At timepoints: T = 0 min (baseline, before consumption) and at t = 15, 30, 45, 60, 90, 120, 150, 180, 210, and 240 min after the study product intake.
Descriptive summary of peak concentration (Cmax) \[µM\] for total AA after consumption of a single serving of a high protein spoonable yoghurt, micellar casein drink, and flavoured water-based placebo jelly in 18-45-year-old males and females over 4 hours.
Incremental Area Under Curve for Total Amino Acids
时间窗: At timepoints: T = 0 min (baseline, before consumption) and at t = 15, 30, 45, 60, 90, 120, 150, 180, 210, and 240 min after the study product intake.
Descriptive summary of incremental area under the curve (iAUC) \[µM\] for total AA after consumption of a single serving of a high protein spoonable yoghurt, micellar casein drink, and flavoured water-based placebo jelly in 18-45-year-old males and females over 4 hours.
次要结局
- Time to Reach Maximum Concentration of Amino Acids(At timepoints: T = 0 min (baseline, before consumption) and at t = 15, 30, 45, 60, 90, 120, 150, 180, 210, and 240 min after the study product intake.)
研究者
Glyn Howatson
Professor
Northumbria University