The Effects of a Commercially Available High Protein Spoonable on Overnight Recovery From Exercise Training in 18-45 Year-old Male and Females
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Muscle Function (Maximal voluntary contraction)
研究概览
简要总结
The key research objective is to examine the effects of a high protein spoonable yoghurt on overnight recovery of muscle function, 12 hours following an exercise session in 18-45-year-old males and females, compared to a control group receiving flavoured waterbased placebo jelly. An additional aim of the study is to explore the effects of the test product vs placebo on muscle function, readiness to exercise and performance in a repeat bout of exercise training at 24 hours following initial exercise training.
详细描述
This study is a single-blind, randomised, parallel group design. It involves six visits to the laboratory in total; Visit 1) pre-screening and consent; visit 2) questionnaires, anthropometrics, and familiarisation; Visit 3) baseline measures; Visit 4) exercise intervention (exercise session 1); Visit 5) post-exercise morning measures, and Visit 6) exercise intervention (exercise session 2). Participants will be randomised into one of two groups that will receive the following;
- Test product: High protein spoonable yoghurt (1 serving = 45 g protein comprising 3 yoghurt pots totalling 480 g) (Danone Nutricia).
- 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 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 BMI will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
Muscle Function (Maximal voluntary contraction)
时间窗: Testing will occur over a two week period (from visit 2-6).This measure will be taken at baseline (visit 3), before and after exercise session 1 (visit 4), 12 hours after exercise session 1 (visit 5) and before and after exercise session 2 (visit 6).
The change from baseline in muscle function (measured via quadriceps maximum voluntary contraction; MVC) 12 hours after exercise session 1. This measurement reflect the ability for the intervention group to recovery faster or have less decrements in function. MVC will be assessed with a bespoke dynamometer (three efforts will be performed).
Muscle Function (Jump Height)
时间窗: Testing will occur over a two week period (from visit 2-6). This measure will be taken at baseline (visit 3), before and after exercise session 1 (visit 4), 12 hours after exercise session 1 (visit 5) and before and after exercise session 2 (visit 6).
The change from baseline in muscle function (assessed by vertical jump height) 12 h after exercise session 1. This measurement reflect the ability for the intervention group to recovery faster or have less decrements in function. Vertical jump height will be assessed by a countermovement jump (CMJ).
Muscle Function (Reactive Strength Index)
时间窗: Testing will occur over a two week period (from visit 2-6). This measure will be taken at baseline (visit 3), before and after exercise session 1 (visit 4), 12 hours after exercise session 1 (visit 5) and before and after exercise session 2 (visit 6).
The change from baseline in muscle function (assessed by reactive strength index; RSI) 12 h after exercise session 1. This measurement reflect the ability for the intervention group to recovery faster or have less decrements in function. RSI will be assessed by three drop jumps (average height and ground contact time \[cm/m, %change\]).
次要结局
- Muscle Function (MVC 24 h post)(Testing will occur over a two week period (from visit 2-6).This measure will be taken at baseline (visit 3), before and after exercise session 1 (visit 4), 12 hours after exercise session 1 (visit 5) and before and after exercise session 2 (visit 6).)
- Muscle Function (Jump Height 24 h post)(Testing will occur over a two week period (from visit 2-6).This measure will be taken at baseline (visit 3), before and after exercise session 1 (visit 4), 12 hours after exercise session 1 (visit 5) and before and after exercise session 2 (visit 6).)
- Muscle Function (RSI 24 h post)(Testing will occur over a two week period (from visit 2-6). This measure will be taken at baseline (visit 3), before and after exercise session 1 (visit 4), 12 hours after exercise session 1 (visit 5) and before and after exercise session 2 (visit 6).)
- Perceived Recovery(Testing will occur over a two week period (from visit 2-6). This measure will be taken at baseline (visit 3), before exercise session 1 (visit 4), 12 hours after exercise session 1 (visit 5) and before exercise session 2 (visit 6).)
- Subjective Muscle Soreness(Testing will occur over a two week period (from visit 2-6). This measure will be taken at baseline (visit 3), before and after exercise session 1 (visit 4), 12 hours after exercise session 1 (visit 5) and before and after exercise session 2 (visit 6).)
- Muscle Pain Pressure(Testing will occur over a two week period (from visit 2-6). This measure will be taken at baseline (visit 3), before and after exercise session 1 (visit 4), 12 hours after exercise session 1 (visit 5) and before and after exercise session 2 (visit 6).)
- Sprint Performance (PPO)(Testing for this measure will occur 48 hour period (two consecutive evening exercise sessions). This measure will be assessed during exercise session 1 (visit 4) and session 2 (visit 6).)
- Sprint Performance (av. PO)(Testing for this measure will occur 48 hour period (two consecutive evening exercise sessions). This measure will be assessed during exercise session 1 (visit 4) and session 2 (visit 6).)
- Sprint Performance (fatigue index)(Testing for this measure will occur 48 hour period (two consecutive evening exercise sessions). This measure will be assessed during exercise session 1 (visit 4) and session 2 (visit 6).)
- Readiness to Train(Testing will occur over a two week period (from visit 2-6). This measure will be taken at baseline (visit 3), before and after exercise session 1 (visit 4), 12 hours after exercise session 1 (visit 5) and before and after exercise session 2 (visit 6).)
- Marker of muscle damage (CK)(Testing will occur over a two week period (from visit 2-6). This measure will be taken at baseline (visit 3), before exercise session 1 (visit 4), 12 hours after exercise session 1 (visit 5) and before exercise session 2 (visit 6).)
- Marker of inflammation (hs-CRP)(Testing will occur over a two week period (from visit 2-6). This measure will be taken at baseline (visit 3), before exercise session 1 (visit 4), 12 hours after exercise session 1 (visit 5) and before exercise session 2 (visit 6).)
- Other performance parameters (peak HR)(Testing for this measure will occur 48 hour period (two consecutive evening exercise sessions). This measure will be assessed during exercise session 1 (visit 4) and session 2 (visit 6).)
- Other performance parameters (mean HR)(Testing for this measure will occur 48 hour period (two consecutive evening exercise sessions). This measure will be assessed during exercise session 1 (visit 4) and session 2 (visit 6).)
- Other performance parameters (RPE)(Testing for this measure will occur 48 hour period (two consecutive evening exercise sessions). This measure will be assessed during exercise session 1 (visit 4) and session 2 (visit 6).)
- Other performance parameters (lactate)(Testing for this measure will occur 48 hour period (two consecutive evening exercise sessions). This measure will be assessed during exercise session 1 (visit 4) and session 2 (visit 6).)
- Perceived Sleep Questionnaire(Testing will occur over a two week period (from visit 2-6). This measure will be taken at baseline (visit 3), before exercise session 1 (visit 4) and 12 hours after exercise session 1 (visit 5).)
研究者
Glyn Howatson
Professor Glyn Howatson
Northumbria University