Spoonable - Overnight Recovery

NCT06986356 | Completed

• 1 other identifier: BOLT_PartB_7943
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Recovery; Muscle Function; Muscle Soreness

Outcome Measures

Primary Outcomes (3)

• Muscle Function (Maximal voluntary contraction)

  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).

  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)

  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).

  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 (Reactive Strength Index)

  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 \[cm/m, %change\]).

  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).

Secondary Outcomes (17)

• 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).

Study Arms (2)

Test Product: Yoghurt

EXPERIMENTAL

High protein commercially available spoonable yoghurt (1 serving = 45 g protein comprising 3 yoghurt pots totalling 480 g) (Danone Nutricia).

Dietary Supplement: Test product: Yoghurt

Control Product: Placebo (Jelly)

PLACEBO COMPARATOR

flavoured water-based placebo jelly (1 serving = 0 g protein comprising 3 jelly pots totalling 480 g).

Dietary Supplement: Placebo

Interventions

Test product: Yoghurt DIETARY_SUPPLEMENT

High protein spoonable yoghurt

Test Product: Yoghurt

Placebo DIETARY_SUPPLEMENT

Placebo Jelly

Control Product: Placebo (Jelly)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northumbria University: lead
• Danone Nutricia Research: collaborator

Study Sites (1)

Northumbria University

Newcastle upon Tyne, United Kingdom

Location

MeSH Terms

Conditions

Myalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Glyn Howatson

  Northumbria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Glyn Howatson

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: May 23, 2025
• Study Start: February 11, 2025
• Primary Completion: June 13, 2025
• Study Completion: June 30, 2025
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)