The Effects of Commercially Available High Protein Drink on Amino Acid Bioavailability and Recovery From Muscle Fatiguing Exercise in 18-45-year-old Male and Female Participants.

NCT07497113 | Completed

• 1 other identifier: BOLT
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Part A = Purpose of study Part A of the BOLT study will focus on characterising the total and essential amino acid concentrations for 4 hours following the consumption of a single serving of: 1) commercially available high-protein yoghurt drink, 2) a micellar casein drink, and 3) a flavoured water-based placebo drink. This is called a bioavailability study. Part B = Purpose of study Part B of the BOLT study will examine the effect of a twice-daily ingestion of 1) high protein yoghurt drink (test product), or 2) flavoured water based drink (control drink) on biomarkers of 1) muscle damage/stress, 2) physical function, 3) self reported pain and muscle soreness, and 4) range of motion, sleep, and recovery assessments, at 24, 48, and 72 hours following acute muscle fatiguing exercise in 18-45-year-old male and female participants. Participants will be randomly allocated to the test product or control drink groups prior to beginning the first visit.

Conditions

Healthy Participants

Keywords

Recovery; Bioavailability

Outcome Measures

Primary Outcomes (7)

• Essential Amino Acids

  Essential Amino Acids = histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, and valine - μmol/L

  Baseline (0 min), 15, 30, 45, 60, 90, 120, 150, 180, 210, and 240 min

• Total Amino Acids

  Total Amino Acids = alanine, arginine, asparagine, aspartic acid, citrulline, cysteine, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, ornithine, phenylalanine, serine, taurine, threonine, tryptophan, tyrosine, valine, and proline - μmol/L

  Baseline (0 min), 15, 30, 45, 60, 90, 120, 150, 180, 210, and 240 min

• Muscle damage biomarker 1

  Creatine kinase - ng/ml

  Baseline (0 hr), post-fatigue exercise (1 hr), 24 hr, 48 hr, 72 hour

• Muscle damage biomarker 2

  Myoglobin - ng/ml

  Baseline (0 hr), post-fatigue exercise (1 hr), 24 hr, 48 hr, 72 hour

• Inflammatory biomarker 1

  Interleukin-6 - pg/mL

  Baseline (0 hr), post-fatigue exercise (1 hr), 24 hr, 48 hr, 72 hour

• Inflammatory biomarker 2

  C-reactive protein - pg/mL

  Baseline (0 hr), post-fatigue exercise (1 hr), 24 hr, 48 hr, 72 hour

• Stress biomarker 1

  Cortisol - µg/dL

  Baseline (0 hr), post-fatigue exercise (1 hr), 24 hr, 48 hr, 72 hour

Secondary Outcomes (26)

• Performance Tests 1

  Baseline (0 hr), post-fatigue exercise (1 hr), 24 hr, 48 hr, 72 hr

• Performance Tests 2

  Baseline (0 hr), post-fatigue exercise (1 hr), 24 hr, 48 hr, 72 hr

• Performance Tests 3

  Baseline (0 hr), post-fatigue exercise (1 hr), 24 hr, 48 hr, 72 hr

• Functional Tests 1

  Baseline (0 hr), post-fatigue exercise (1 hr), 24 hr, 48 hr, 72 hr

• Functional Tests 2

  Baseline (0 hr), post-fatigue exercise (1 hr), 24 hr, 48 hr, 72 hr

Other Outcomes (4)

• Fatigue Tests 1

  Pre (30 mins), during and post muscle fatigue protocol (1 hr)

• Fatigue Tests 2

  Pre (30 mins), during and post muscle fatigue protocol (1 hr)

• Fatigue Tests 3

  Pre (30 mins) and post muscle fatigue protocol (1 hr)

Study Arms (3)

Protein drink

EXPERIMENTAL

Commercially available high-protein yoghurt drink

Dietary Supplement: Commercially available high-protein yoghurt drink

Control drink #1

ACTIVE COMPARATOR

Micellar casein drink

Dietary Supplement: Active Comparator: Control drink #1

Control drink #2

PLACEBO COMPARATOR

Flavoured water-based placebo drink

Dietary Supplement: Placebo Comparator: Control drink #2

Interventions

Commercially available high-protein yoghurt drink DIETARY_SUPPLEMENT

High protein yoghurt drink (1 serving = 25g protein, 300ml),

Protein drink

Active Comparator: Control drink #1 DIETARY_SUPPLEMENT

Micellar casein drink (1 serving = 25g protein, 300 ml),

Control drink #1

Placebo Comparator: Control drink #2 DIETARY_SUPPLEMENT

Flavoured water-based placebo drink (1 serving = 0g protein, 300 ml),

Control drink #2

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 (measured at the first assessment),
• Written informed consent (undertaken at the first assessment).
• 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 might interfere 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 dietary allergies.
• Any known intolerances to ingredients of the study product, i.e. dairy, cow's milk allergies, lactose intolerance.
• Self-reported 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 protein supplementation or a weight loss program, as confirmed via the screening process.
• Use of any nutritional supplements or additional protein supplements or nutritional support within 4 weeks prior to screening.
• Engage (on average) in more than 2 resistance exercise sessions and/or more than 4 exercise sessions in total weekly within 2 months before screening,

Sponsors & Collaborators

• Anglia Ruskin University: lead
• Danone Global Research & Innovation Center: collaborator

Study Sites (1)

Anglia Ruskin University

Cambridge, RH14 9YY, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Part A = a three-way, single-blind, randomised, cross-over study design. Part B = a double-blind, parallel, randomised group design.

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 27, 2026
• Study Start: March 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: February 28, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)