Spoonable Bioavailability

NCT06733142 | Completed

• 1 other identifier: BOLT_PartA_7911
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amino Acid Absorption; Amino Acid Plasma Profile; Amino Acids, Essential

Keywords

Bioavailability; High Protein; Amino Acids

Outcome Measures

Primary Outcomes (2)

• Peak Concentration for Total Amino Acids

  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.

  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.

• Incremental Area Under Curve for Total Amino Acids

  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.

  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.

Secondary Outcomes (1)

• 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.

Study Arms (3)

Test Product

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

Micellar casein drink

ACTIVE COMPARATOR

Micellar casein drink (1 serving = 45 g protein/480 g).

Dietary Supplement: Micellar casein drink

Placebo

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

Micellar casein drink DIETARY_SUPPLEMENT

Micellar casein drink made from water, casein powder and fruit syrup

Micellar casein drink

Placebo DIETARY_SUPPLEMENT

Placebo sugar free jelly

Placebo

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

• Glyn Howatson: lead
• Danone Nutricia Research: collaborator

Study Sites (1)

Northumbria University

Newcastle upon Tyne, United Kingdom

Location

Related Publications (1)

• McKay AKA, Stellingwerff T, Smith ES, Martin DT, Mujika I, Goosey-Tolfrey VL, Sheppard J, Burke LM. Defining Training and Performance Caliber: A Participant Classification Framework. Int J Sports Physiol Perform. 2022 Feb 1;17(2):317-331. doi: 10.1123/ijspp.2021-0451. Epub 2022 Dec 29.

  PMID: 34965513 BACKGROUND

Study Officials

• Glyn Howatson

  Northumbria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-Blinded
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: December 13, 2024
• Study Start: October 9, 2024
• Primary Completion: December 12, 2024
• Study Completion: January 20, 2025
• Last Updated: May 21, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)