Status:
ACTIVE_NOT_RECRUITING
Spoonable - Overnight Recovery
Lead Sponsor:
Northumbria University
Collaborating Sponsors:
Danone Nutricia Research
Conditions:
Recovery
Muscle Function
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
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 fe...
Detailed Description
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 fa...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06986356
Start Date
February 11 2025
End Date
September 30 2025
Last Update
May 23 2025
Active Locations (1)
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1
Northumbria University
Newcastle upon Tyne, United Kingdom