SarcopeniaPARNCT04935788
Postprandial Amino Acid Response After Protein Consumption
A study testing milk protein, micellar casein and pea protein in people with Sarcopenia, run by Wageningen University at 1 site in Netherlands.
Trial summary
Increasing muscle protein synthesis via protein-based nutrition, with or without exercise, maintains a strong, healthy muscle mass, which in turn leads to improved health, independence and functionality in older adults. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- milk protein, micellar casein and pea protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2021to 1 Jul 2022
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥60 and ≤80
- BMI ≥20 and ≤32 kg/m2
- Non-smoking
- Healthy as assessed by a lifestyle and health questionnaire ("Verklaring leefgewoonten en gezondheid") and according to the judgment of the study physician.
- Regular and normal Dutch eating habits as assessed by a lifestyle and health questionnaire (3 main meals per day)
- Veins suitable for cannulation (blood sampling)
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- Voluntary participation
- Having given written informed consent
- Willing to comply with study procedures
- Accept use of all encoded data, including publication, and the confidential use and storage of all data for 15 years.
- Accept disclosure of the financial benefit of participation in the study to the authorities concerned
Who cannot join
- Participation in any clinical trial including blood sampling and/or administration of substances up to 30 days before day 1 of this study
- Having a history of medical or surgical events that may significantly affect the study outcome, including: Inflammatory bowel disease, hepatitis, pancreatitis, ulcers, gastrointestinal or rectal bleeding; major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; known or suspected gastrointestinal disorders, colon or GI tract cancer
- Use of the following medication: glucose lowering drugs, insulin; medication that may impact gastric emptying (e.g. gastric acid inhibitors or laxatives)
- Diagnosed with diabetes, being treated for high blood glucose or increased fasting blood glucose (> 7 mmol/l in finger prick blood) as assessed during screening visit
- For men: Hb <8,5 mmol/l as assessed during screening visit; for women: Hb <7,5 mmol/l
- Use of protein supplements
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- Mental status that is incompatible with the proper conduct of the study
- A self-reported reported food allergy or sensitivity to dairy or plant ingredients
- Alcohol consumption for men > 28 units/week and >4/day; for women: >21 units/week and >3/day
- Reported unexpected 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
- Reported slimming or medically prescribed diet
- Recent blood donation (<1 month prior to Day 01 of the study)
- Not willing to give up blood donation during the study
- Not having a general practitioner
- Not willing to accept information-transfer concerning participation in the study, or information regarding his or her health, like laboratory results and eventual adverse events to and from his general practitioner
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Division of Human Nutrition, Wageningen University
Wageningen, Gelderland, 6703 HA
About this study
Official title: The Acute Postprandial Response of Blood Amino Acids in Older Adults After Consumption of Dairy Protein, Plant Protein and Their Blend
Increasing muscle protein synthesis via protein-based nutrition, with or without exercise, maintains a strong, healthy muscle mass, which in turn leads to improved health, independence and functionality in older adults. There is increased interest in plant-based proteins, but these have in general a lower anabolic effect than animal proteins. Various strategies have been suggested to augment the anabolic properties of plant proteins, including using plant-animal protein blends. However, only little is known yet about the anabolic properties of such an approach. As the peripheral metabolic availability of proteins is an important aspect that has to be taken into account when screening the anabolic properties of protein sources/blends, it is the aim of this study to investigate the postprandial AA response of milk protein, micellar casein, pea protein, and a milk protein-pea protein blend in healthy older adults.
Read the detailed description
Objective:
The primary objective is to quantify the postprandial area under the curve (iAUC), the maximal level (Cmax) and the time profile (Tmax) of blood amino acids after ingestion of milk protein, micellar casein, pea protein, and a milk protein-pea protein blend in healthy older adults.
Secondary objectives are to quantify the postprandial insulin response, and to quantify the potential muscular response, using an in vitro muscle cell assay, of postprandial blood derived from healthy older adults after ingestion of milk protein, micellar casein, pea protein, and a milk protein-pea protein blend.
Study design: The study is designed as a randomized, single-blinded within-subject (cross-over) trial in which a group of 12 subjects receive 4 different protein drinks.
Study population: Healthy older adults (60-80 years) Intervention (if applicable): Four different protein drinks will be investigated: milk protein, micellar casein, pea protein, and a milk protein/ pea protein blend. All drinks will contain a 20 gram protein load. All protein supplements will be mixed with 250 mL water and contain some additional non-caloric flavorings.
Main study parameters/endpoints: Postprandial blood amino acid response, up to 5 hours after consumption of a protein drink measured (incremental area under curve, Cmax and Tmax).
- Conditions
- Sarcopenia
- Being tested
- milk protein, micellar casein, pea protein, milk/pea protein blend
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
milk proteinDietary supplement
milk protein supplement
micellar caseinDietary supplement
micellar casein supplement
pea proteinDietary supplement
pea protein supplement
milk/pea protein blendDietary supplement
milk/pea protein supplement
| Study group | Role | What they receive |
|---|---|---|
| milk protein | Experimental | milk protein supplement Receives: Dietary Supplement: milk protein |
| micellar casein | Experimental | casein supplement Receives: Dietary Supplement: micellar casein |
| pea protein | Experimental | pea protein supplement Receives: Dietary Supplement: pea protein |
| milk/pea protein | Experimental | a blend of milk and pea protein Receives: Dietary Supplement: milk/pea protein blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma AA
postprandial plasma AA response
Measured: 5 hours
Secondary outcomes (1)
Insulin
postprandial insulin response
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start1 Nov 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Model description
- a randomized, single-blinded within-subject (cross-over) trial in which a group of 12 subjects receive 4 different conditions
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- NIZO Food Research, Ingredia S.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935788
- Sponsor's protocol ID
- NL78067.028.21
- Acronym
- PAR
- Status last verified
- Jun 2021
- First submitted
- 11 Jun 2021
- Last updated
- 29 Jun 2021
- 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 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Postprandial Response of Blood Amino Acids in Older Adults After Consumption of Dairy Protein, Plant Protein and Their Blend
- ClinicalTrials.gov ID
- NCT04935788
- Acronym / sponsor ID
- PAR / NL78067.028.21
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- NIZO Food Research, Ingredia S.A.
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 23 Jun 2021 (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.
Increasing muscle protein synthesis via protein-based nutrition, with or without exercise, maintains a strong, healthy muscle mass, which in turn leads to improved health, independence and functionality in older adults. There is increased interest in plant-based proteins, but these have in general a lower anabolic effect than animal proteins. Various strategies have been suggested to augment the anabolic properties of plant proteins, including using plant-animal protein blends. However, only little is known yet about the anabolic properties of such an approach. As the peripheral metabolic availability of proteins is an important aspect that has to be taken into account when screening the anabolic properties of protein sources/blends, it is the aim of this study to investigate the postprandial AA response of milk protein, micellar casein, pea protein, and a milk protein-pea protein blend in healthy older adults.
Detailed description
Objective:
The primary objective is to quantify the postprandial area under the curve (iAUC), the maximal level (Cmax) and the time profile (Tmax) of blood amino acids after ingestion of milk protein, micellar casein, pea protein, and a milk protein-pea protein blend in healthy older adults.
Secondary objectives are to quantify the postprandial insulin response, and to quantify the potential muscular response, using an in vitro muscle cell assay, of postprandial blood derived from healthy older adults after ingestion of milk protein, micellar casein, pea protein, and a milk protein-pea protein blend.
Study design: The study is designed as a randomized, single-blinded within-subject (cross-over) trial in which a group of 12 subjects receive 4 different protein drinks.
Study population: Healthy older adults (60-80 years) Intervention (if applicable): Four different protein drinks will be investigated: milk protein, micellar casein, pea protein, and a milk protein/ pea protein blend. All drinks will contain a 20 gram protein load. All protein supplements will be mixed with 250 mL water and contain some additional non-caloric flavorings.
Main study parameters/endpoints: Postprandial blood amino acid response, up to 5 hours after consumption of a protein drink measured (incremental area under curve, Cmax and Tmax).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- a randomized, single-blinded within-subject (cross-over) trial in which a group of 12 subjects receive 4 different conditions
| Arm | Type | Receives |
|---|---|---|
| milk protein | Experimental | Dietary Supplement: milk proteinmilk protein supplement |
| micellar casein | Experimental | Dietary Supplement: micellar caseincasein supplement |
| pea protein | Experimental | Dietary Supplement: pea proteinpea protein supplement |
| milk/pea protein | Experimental | Dietary Supplement: milk/pea protein blenda blend of milk and pea protein |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥60 and ≤80
- BMI ≥20 and ≤32 kg/m2
- Non-smoking
- Healthy as assessed by a lifestyle and health questionnaire ("Verklaring leefgewoonten en gezondheid") and according to the judgment of the study physician.
- Regular and normal Dutch eating habits as assessed by a lifestyle and health questionnaire (3 main meals per day)
Key exclusion criteria (15 listed)
- Participation in any clinical trial including blood sampling and/or administration of substances up to 30 days before day 1 of this study
- Having a history of medical or surgical events that may significantly affect the study outcome, including: Inflammatory bowel disease, hepatitis, pancreatitis, ulcers, gastrointestinal or rectal bleeding; major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; known or suspected gastrointestinal disorders, colon or GI tract cancer
- Use of the following medication: glucose lowering drugs, insulin; medication that may impact gastric emptying (e.g. gastric acid inhibitors or laxatives)
- Diagnosed with diabetes, being treated for high blood glucose or increased fasting blood glucose (> 7 mmol/l in finger prick blood) as assessed during screening visit
- For men: Hb <8,5 mmol/l as assessed during screening visit; for women: Hb <7,5 mmol/l
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 |
|---|---|---|
| milk proteinmilk protein supplement | Dietary supplement | milk protein |
| micellar caseinmicellar casein supplement | Dietary supplement | micellar casein |
| pea proteinpea protein supplement | Dietary supplement | pea protein |
| milk/pea protein blendmilk/pea protein supplement | Dietary supplement | milk/pea protein |
Primary outcome
plasma AA
Time frame: 5 hours
postprandial plasma AA response
1 secondary outcome
Insulin
Time frame: 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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 milk protein, micellar casein and pea protein in people with Sarcopenia, run by Wageningen University 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 11 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 29 Jun 2021. 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?
Results are not available in the source record.
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 AA (time frame: 5 hours). 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 29 Jun 2021.