Amino Acid Plasma ProfileDaPaNCT05813769
Dairy and Plant Amino Acid Uptake. An Explorative Study
A study testing Dairy protein and Plant protein in people with Amino Acid Plasma Profile, run by FrieslandCampina at 1 site in Netherlands.
Trial summary
To optimize the environmental sustainability, a protein transition to more plant-based protein sources is required. However, the protein quality of plant-based sources is lower than that of the dairy proteins casein and whey, which contain high levels of essential amino acids. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Amino Acid Plasma Profile
- What is being tested?
- Dairy protein and Plant protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 May 2023to 21 Jun 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
- Apparently healthy men and women;
- Age ≥18 and ≤40 years;
- Body mass index (BMI) ≥18.5 and ≤30 kg/m2 ;
- Having veins suitable for blood sampling via a catheter (judged by study nurse/ medical doctor).
Who cannot join
- Any self-reported metabolic, gastrointestinal, inflammatory or chronic disease (such as anemia, diabetes, hepatitis, cardiovascular disease);
- Having a history of medical or surgical events that may significantly affect the study outcome;
- Anaemia (Haemoglobin (Hb) values <7.5 mmol/L for women and <8.5 mmol/L for men), as assessed by finger prick blood during screening visit;
- Having a food or protein allergy
- Use of glucose lowering drugs, insulin;
- Use of medication that may impact gastric emptying (e.g. gastric acid inhibitors or laxatives);
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- Use of antibiotic treatment less than 1 month before start of the study and during the study;
- Use of anti-depressives as a treatment for depression;
- Use of protein supplements (must be stopped 1 week before the first test day);
- Reported weight loss or weight gain of > 3 kg in the month prior to pre-study screening, or intention to lose weight during the study period;
- Reporting to follow or having planned a slimming or medically prescribed diet.
- Not willing to keep a stable lifestyle during the study period;
- Recent blood donation (<1 month prior to test day 1 of the study) or not willing to stop donation during and 1 month after the study;
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Wageningen Food & Biobased Research, Food, Health & Consumer Research
Wageningen, Gelderland, 6708 WG
About this study
To optimize the environmental sustainability, a protein transition to more plant-based protein sources is required. However, the protein quality of plant-based sources is lower than that of the dairy proteins casein and whey, which contain high levels of essential amino acids. The amino acid absorption characteristics of many plant-based proteins are unknown.
The present study aims to estimate differences in postprandial plasma total essential amino acids (TEAA) profiles after protein consumption of different protein sources in blood of healthy participants. This explorative study has a randomized, cross-over, double-blind, controlled design.
- Conditions
- Amino Acid Plasma Profile
- Being tested
- Dairy protein, Plant protein
- Keywords
- Dairy protein, Plant protein, Postprandial plasma amino acid profiles, Essential amino acids (EAA), Total amino acids (AA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dairy proteinDietary supplement
During each visit, research subjects will receive the product dissolved in water, representing a 20g protein load.
Plant proteinDietary supplement
During each visit, research subjects will receive the product dissolved in water, representing a 20g protein load.
| Study group | Role | What they receive |
|---|---|---|
| Dairy protein 1 | Active comparator | Not described Receives: Dietary Supplement: Dairy protein |
| Dairy protein 2 | Active comparator | Not described Receives: Dietary Supplement: Dairy protein |
| Plant protein 1 | Experimental | Not described Receives: Dietary Supplement: Plant protein |
| Plant protein 2 | Experimental | Not described Receives: Dietary Supplement: Plant protein |
| Plant protein 2 + added AA | Experimental | Not described Receives: Dietary Supplement: Plant protein |
| Plant protein 2 + Dairy protein 2 | Experimental | Not described Receives: Dietary Supplement: Dairy protein; Dietary Supplement: Plant protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial blood TEAA profiles
Postprandial plasma total essential amino acids (TEAA) profiles after protein consumption, determined by appearance in blood.
Measured: Frome baseline up to 5 hours postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start9 May 2023
- Primary completion21 Jun 2023
- Study completion21 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amino Acid Plasma ProfileStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- FrieslandCampina
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wageningen University and Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813769
- Sponsor's protocol ID
- DaPa
- Acronym
- DaPa
- Status last verified
- Jun 2023
- First submitted
- 27 Mar 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dairy and Plant Amino Acid Uptake. An Explorative Study
- ClinicalTrials.gov ID
- NCT05813769
- Acronym / sponsor ID
- DaPa / DaPa
- Conditions
- Amino Acid Plasma Profile
- Keywords
- Dairy protein, Plant protein, Postprandial plasma amino acid profiles, Essential amino acids (EAA), Total amino acids (AA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- FrieslandCampinaIndustry (pharma, biotech, devices)
- Collaborators
- Wageningen University and Research
- Study start
- 9 May 2023 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 14 Apr 2023 (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.
To optimize the environmental sustainability, a protein transition to more plant-based protein sources is required. However, the protein quality of plant-based sources is lower than that of the dairy proteins casein and whey, which contain high levels of essential amino acids. The amino acid absorption characteristics of many plant-based proteins are unknown.
The present study aims to estimate differences in postprandial plasma total essential amino acids (TEAA) profiles after protein consumption of different protein sources in blood of healthy participants. This explorative study has a randomized, cross-over, double-blind, controlled design.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dairy protein 1 | Active comparator | Dietary Supplement: Dairy protein |
| Dairy protein 2 | Active comparator | Dietary Supplement: Dairy protein |
| Plant protein 1 | Experimental | Dietary Supplement: Plant protein |
| Plant protein 2 | Experimental | Dietary Supplement: Plant protein |
| Plant protein 2 + added AA | Experimental | Dietary Supplement: Plant protein |
| Plant protein 2 + Dairy protein 2 | Experimental | Dietary Supplement: Dairy protein, Dietary Supplement: Plant protein |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Apparently healthy men and women;
- Age ≥18 and ≤40 years;
- Body mass index (BMI) ≥18.5 and ≤30 kg/m2 ;
- Having veins suitable for blood sampling via a catheter (judged by study nurse/ medical doctor).
Key exclusion criteria (13 listed)
- Any self-reported metabolic, gastrointestinal, inflammatory or chronic disease (such as anemia, diabetes, hepatitis, cardiovascular disease);
- Having a history of medical or surgical events that may significantly affect the study outcome;
- Anaemia (Haemoglobin (Hb) values <7.5 mmol/L for women and <8.5 mmol/L for men), as assessed by finger prick blood during screening visit;
- Having a food or protein allergy
- Use of glucose lowering drugs, insulin;
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 |
|---|---|---|
| Dairy proteinDuring each visit, research subjects will receive the product dissolved in water, representing a 20g protein load. | Dietary supplement | Dairy protein 1, Dairy protein 2, Plant protein 2 + Dairy protein 2 |
| Plant proteinDuring each visit, research subjects will receive the product dissolved in water, representing a 20g protein load. | Dietary supplement | Plant protein 1, Plant protein 2, Plant protein 2 + Dairy protein 2, Plant protein 2 + added AA |
Primary outcome
Postprandial blood TEAA profiles
Time frame: Frome baseline up to 5 hours postprandial
Postprandial plasma total essential amino acids (TEAA) profiles after protein consumption, determined by appearance in blood.
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 26 Jun 2023.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dairy protein and Plant protein in people with Amino Acid Plasma Profile, run by FrieslandCampina at 1 site in Netherlands.
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 4 inclusion and 13 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 26 Jun 2023. 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 Netherlands. 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?
Postprandial blood TEAA profiles (time frame: Frome baseline up to 5 hours postprandial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2023.