Amino Acid AbsorptionBOLT_Part ANCT06733142
Spoonable Bioavailability
A study testing Test Product: Yoghurt and Micellar casein drink in people with Amino Acid Absorption and Amino Acid Plasma Profile, run by Glyn Howatson at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Amino Acid Absorption, Amino Acid Plasma Profile, Amino Acids, Essential
- What is being tested?
- Test Product: Yoghurt and Micellar casein drink
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Oct 2024to 20 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a Commercially Available High Protein Spoonable on Amino Acid Bioavailability in 18-45-year-old Male and Female Volunteers.
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.
Read the detailed description
This study is a single-blind, three-way, randomised crossover design. It involves four visits to the laboratory in total; the first session will be a pre-screening and familiarisation, and the subsequent three sessions will be 3 x bioavailability assessments, separated by a washout period of a minimum of 5 days and maximum of 21 days. The bioavailability assessments will be identical except for the product consumed; subjects will receive one serving of the following in a random order:
- Test product: High protein spoonable yoghurt (1 serving = 45 g protein comprising 3 yoghurt pots totalling 480 g) (Danone Nutricia).
- Control product 1: Micellar casein drink (1 serving = 45 g protein/480 g).
- 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 fourth and 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 body mass index (BMI) will be measured.
Visits 2-4: Bioavailability assessments: Subjects will refrain from physical activity and alcohol consumption 24 hours before each visit and caffeine 12 hours before each visit. After an overnight fast (at least 10 hours), subjects will come to the lab to participate. Study staff will collect food and exercise diaries from subjects. If the inclusion criteria continue to be met, participants can continue into the trial. A cannula will be inserted into an antecubital vein by a qualified member of the study team, with appropriate standard procedures for cannula care followed throughout the visit duration.
Subjects will consume one serving of one of the study products (~10 minutes). Subjects Blood samples will be drawn at time (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. Throughout the study visits, subjects are not allowed to eat, but will be permitted to drink up to 250 mL of water after the first 2 hours - the volume consumed and timing during Visit 2 will be replicated as best as possible on subsequent visits. In addition, subjects will be asked to abstain from any physical exercise other than incidental walking during the study visits.
Within 5-21 days after Visit 2, volunteers will undergo the same intervention with the second and then third study products at Visits 3 and 4, respectively.
- Being tested
- Test Product: Yoghurt, Micellar casein drink, Placebo
- Keywords
- Bioavailability, High Protein, Amino Acids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Product: YoghurtDietary supplement
High protein spoonable yoghurt
Micellar casein drinkDietary supplement
Micellar casein drink made from water, casein powder and fruit syrup
PlaceboDietary supplement
Placebo sugar free jelly
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | High protein commercially available spoonable yoghurt (1 serving = 45 g protein comprising 3 yoghurt pots totalling 480 g) (Danone Nutricia). Receives: Dietary Supplement: Test Product: Yoghurt |
| Micellar casein drink | Active comparator | Micellar casein drink (1 serving = 45 g protein/480 g). Receives: 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). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Descriptive summary of time to reach maximum concentration (Tmax) [min] of 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start9 Oct 2024
- Primary completion12 Dec 2024
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amino Acid AbsorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glyn Howatson
- Sponsor type
- University, hospital or other
- Collaborators
- Danone Nutricia Research
- Responsible party
- Sponsor-investigator, Glyn Howatson, Northumbria University
- Investigators
- Glyn Howatson, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733142
- Sponsor's protocol ID
- BOLT_PartA_7911
- Acronym
- BOLT_Part A
- Status last verified
- Dec 2024
- First submitted
- 25 Oct 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34965513
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Commercially Available High Protein Spoonable on Amino Acid Bioavailability in 18-45-year-old Male and Female Volunteers.
- ClinicalTrials.gov ID
- NCT06733142
- Acronym / sponsor ID
- BOLT_Part A / BOLT_PartA_7911
- Keywords
- Bioavailability, High Protein, Amino Acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Glyn HowatsonUniversity, hospital or other
- Collaborators
- Danone Nutricia Research
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a single-blind, three-way, randomised crossover design. It involves four visits to the laboratory in total; the first session will be a pre-screening and familiarisation, and the subsequent three sessions will be 3 x bioavailability assessments, separated by a washout period of a minimum of 5 days and maximum of 21 days. The bioavailability assessments will be identical except for the product consumed; subjects will receive one serving of the following in a random order:
- Test product: High protein spoonable yoghurt (1 serving = 45 g protein comprising 3 yoghurt pots totalling 480 g) (Danone Nutricia).
- Control product 1: Micellar casein drink (1 serving = 45 g protein/480 g).
- 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 fourth and 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 body mass index (BMI) will be measured.
Visits 2-4: Bioavailability assessments: Subjects will refrain from physical activity and alcohol consumption 24 hours before each visit and caffeine 12 hours before each visit. After an overnight fast (at least 10 hours), subjects will come to the lab to participate. Study staff will collect food and exercise diaries from subjects. If the inclusion criteria continue to be met, participants can continue into the trial. A cannula will be inserted into an antecubital vein by a qualified member of the study team, with appropriate standard procedures for cannula care followed throughout the visit duration.
Subjects will consume one serving of one of the study products (~10 minutes). Subjects Blood samples will be drawn at time (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. Throughout the study visits, subjects are not allowed to eat, but will be permitted to drink up to 250 mL of water after the first 2 hours - the volume consumed and timing during Visit 2 will be replicated as best as possible on subsequent visits. In addition, subjects will be asked to abstain from any physical exercise other than incidental walking during the study visits.
Within 5-21 days after Visit 2, volunteers will undergo the same intervention with the second and then third study products at Visits 3 and 4, respectively.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Dietary Supplement: Test Product: YoghurtHigh protein commercially available spoonable yoghurt (1 serving = 45 g protein comprising 3 yoghurt pots totalling 480 g) (Danone Nutricia). |
| Micellar casein drink | Active comparator | Dietary Supplement: Micellar casein drinkMicellar casein drink (1 serving = 45 g protein/480 g). |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboFlavoured water-based placebo jelly (1 serving = 0 g protein comprising 3 jelly pots totalling 480 g). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test Product: YoghurtHigh protein spoonable yoghurt | Dietary supplement | Test Product |
| Micellar casein drinkMicellar casein drink made from water, casein powder and fruit syrup | Dietary supplement | Micellar casein drink |
| PlaceboPlacebo sugar free jelly | Dietary supplement | Placebo |
Primary outcome
Peak Concentration for Total Amino Acids
Time frame: 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.
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.
Incremental Area Under Curve for Total Amino Acids
Time frame: 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.
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.
1 secondary outcome
Time to Reach Maximum Concentration of Amino Acids
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Results publication: PubMed 34965513McKay 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.
- Individual participant dataSharing planned: No
Related trials for Amino Acid Absorption
Not yet recruiting
Measurement of Acute Metabolite Changes Following Consumption of Microalgae Drinks
Protein Absorption and Amino Acid Availability, Metabolomics
Not yet recruiting
cGMP: Metabolism and Appetite Modulation
Healthy
Not yet recruiting
Changes in Amino Acid Absorption After Adding a Probiotic to an Acute Protein Feeding
Amino Acid Absorption, Probiotic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glyn Howatson principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test Product: Yoghurt and Micellar casein drink in people with Amino Acid Absorption and Amino Acid Plasma Profile, run by Glyn Howatson at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Concentration for Total Amino Acids (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06733142, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.