Postprandial Plasma Amino Acid AvailabilityBABENCT05584358
Protein Extrusion and Postprandial Amino Acid Handling
A study testing Dry protein blend ingestion and Extruded protein blend ingestion in people with Postprandial Plasma Amino Acid Availability, run by University of Exeter at 2 sites in United Kingdom.
Trial summary
The bulk of research that has investigated the effect of dietary protein on muscle tissue in humans has used isolated, minimally processed protein powders. However, the protein that we consume on a daily basis has typically undergone various processing methods, and evidence suggests these can change the way our bodies… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Plasma Amino Acid Availability
- What is being tested?
- Dry protein blend ingestion and Extruded protein blend ingestion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 2 Feb 2022to 31 Aug 2023
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 18 and 30.
- Metabolically healthy
Who cannot join
- Any metabolic impairments
- cardio/pulmonary diseases.
- Chronic use of the over the counter medicine
- A personal or family history of epilepsy, seizures or schizophrenia.
- Allergic to mycoprotein/Quorn/edible fungi/environmental mould products.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Sport & Health Sciences University of Exeter
Exeter, Devon, EX1 2LU
University of Exeter
Exeter, Devon, EX1 2LU
About this study
Official title: The Impact of the Extrusion Process During Dietary Protein Production on in Vivo Postprandial Amino Acid Availability
The bulk of research that has investigated the effect of dietary protein on muscle tissue in humans has used isolated, minimally processed protein powders. However, the protein that we consume on a daily basis has typically undergone various processing methods, and evidence suggests these can change the way our bodies metabolise the protein. 'Extrusion' is a common processing method that uses high pressure to produce protein containing cereals and meat replacement foods. There is currently no research looking at how extrusion affects the way a protein source is digested and absorbed in humans. This study will compare the availability of ingested protein in the blood in the hours following consumption of an extruded versus a non-extruded source.
- Being tested
- Dry protein blend ingestion, Extruded protein blend ingestion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry protein blend ingestionDietary supplement
Ingestion of protein blend powders mixed in water
Extruded protein blend ingestionDietary supplement
Ingestion of protein blend powders mixed in water
| Study group | Role | What they receive |
|---|---|---|
| Dry Blend | Experimental | A dry blend of mycoprotein and pea protein. Receives: Dietary Supplement: Dry protein blend ingestion |
| Extrudate | Experimental | An extruded blend of mycoprotein and pea protein Receives: Dietary Supplement: Extruded protein blend ingestion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma amino acid concentrations
The rate of appearance of amino acids ingested in the drink
Measured: 5 hours
Secondary outcomes (3)
Blood glucose
The concentrations of glucose in the blood
Measured: 5 hours
Serum insulin
The concentration of insulin in the blood
Measured: 5 hours
Resting metabolic rate
The amount of energy used to digest the protein
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start2 Feb 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
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 Postprandial Plasma Amino Acid AvailabilityStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- Quorn
- Responsible party
- Sponsor
- Investigators
- Benjamin Wall, Principal investigator, Professor of Nutritional Physiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584358
- Sponsor's protocol ID
- 21-10-20-A-06 v2
- Acronym
- BABE
- Status last verified
- Jan 2024
- First submitted
- 24 Jan 2022
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
West S, Monteyne AJ, Whelehan G, Abdelrahman DR, Murton AJ, Finnigan TJ, Mandalari G, Booth C, Wilde PJ, Stephens FB, Wall BT. High-Moisture Extrusion of a Dietary Protein Blend Impairs In Vitro Digestion and Delays In Vivo Postprandial Plasma Amino Acid Availability in Humans. J Nutr. 2024 Jul;154(7):2053-2064. doi: 10.1016/j.tjnut.2024.05.018. Epub 2024 May 24.
PubMed 38797481
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Extrusion Process During Dietary Protein Production on in Vivo Postprandial Amino Acid Availability
- ClinicalTrials.gov ID
- NCT05584358
- Acronym / sponsor ID
- BABE / 21-10-20-A-06 v2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- Quorn
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 18 Oct 2022 (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 bulk of research that has investigated the effect of dietary protein on muscle tissue in humans has used isolated, minimally processed protein powders. However, the protein that we consume on a daily basis has typically undergone various processing methods, and evidence suggests these can change the way our bodies metabolise the protein. 'Extrusion' is a common processing method that uses high pressure to produce protein containing cereals and meat replacement foods. There is currently no research looking at how extrusion affects the way a protein source is digested and absorbed in humans. This study will compare the availability of ingested protein in the blood in the hours following consumption of an extruded versus a non-extruded source.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Blend | Experimental | Dietary Supplement: Dry protein blend ingestionA dry blend of mycoprotein and pea protein. |
| Extrudate | Experimental | Dietary Supplement: Extruded protein blend ingestionAn extruded blend of mycoprotein and pea protein |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI between 18 and 30.
- Metabolically healthy
Key exclusion criteria (5 listed)
- Any metabolic impairments
- cardio/pulmonary diseases.
- Chronic use of the over the counter medicine
- A personal or family history of epilepsy, seizures or schizophrenia.
- Allergic to mycoprotein/Quorn/edible fungi/environmental mould products.
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 |
|---|---|---|
| Dry protein blend ingestionIngestion of protein blend powders mixed in water | Dietary supplement | Dry Blend |
| Extruded protein blend ingestionIngestion of protein blend powders mixed in water | Dietary supplement | Extrudate |
Primary outcome
Plasma amino acid concentrations
Time frame: 5 hours
The rate of appearance of amino acids ingested in the drink
3 secondary outcomes
Blood glucose
Time frame: 5 hours
Serum insulin
Time frame: 5 hours
Resting metabolic rate
Time frame: 5 hours
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 11 Jan 2024.
- Derived from this study: PubMed 38797481West S, Monteyne AJ, Whelehan G, Abdelrahman DR, Murton AJ, Finnigan TJ, Mandalari G, Booth C, Wilde PJ, Stephens FB, Wall BT. High-Moisture Extrusion of a Dietary Protein Blend Impairs In Vitro Digestion and Delays In Vivo Postprandial Plasma Amino Acid Availability in Humans. J Nutr. 2024 Jul;154(7):2053-2064. doi: 10.1016/j.tjnut.2024.05.018. Epub 2024 May 24.
- Individual participant dataSharing planned: No
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.
Benjamin Wall principal investigator
Professor of Nutritional Physiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry protein blend ingestion and Extruded protein blend ingestion in people with Postprandial Plasma Amino Acid Availability, run by University of Exeter at 2 sites 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 2 inclusion and 5 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 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Plasma amino acid concentrations (time frame: 5 hours). 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 NCT05584358, 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 11 Jan 2024.