Protein Digestion KineticsRAPNCT03547362
Real-time Amino Acid Profiling
A study testing Casein, Dairy protein blend 1 and Whey protein in people with Protein Digestion Kinetics, run by NIZO Food Research at 1 site in Netherlands.
Trial summary
This study was designed to obtain information about the effect of new combinations of dairy proteins, in small servings with high protein concentrations, on postprandial amino acid kinetics in blood in an older population. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Protein Digestion Kinetics
- What is being tested?
- Casein, Dairy protein blend 1 and Whey protein
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 May 2018to 5 Jul 2018
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age ≥65 and ≤80
- BMI ≥20 and ≤32 kg/m2
- Non-smoking
- Healthy as assessed by the NIZO 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 the NIZO 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 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
- Personnel of NIZO food research and FrieslandCampina, their partner and their first and second degree relatives
- 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.
About this study
This study was designed to obtain information about the effect of new combinations of dairy proteins, in small servings with high protein concentrations, on postprandial amino acid kinetics in blood in an older population.
- Conditions
- Protein Digestion Kinetics
- Being tested
- Casein, Dairy protein blend 1, Whey protein, Dairy protein blend 2, Dairy protein blend 3
- Keywords
- Amino acids, Dairy proteins, Postprandial, Older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaseinDietary supplement
See arm description
Dairy protein blend 1Dietary supplement
See arm description
Whey proteinDietary supplement
See arm description
Dairy protein blend 2Dietary supplement
See arm description
Dairy protein blend 3Dietary supplement
See arm description
Dairy protein blend 4Dietary supplement
See arm description
| Study group | Role | What they receive |
|---|---|---|
| Casein | Experimental | Single oral administration Receives: Dietary Supplement: Casein |
| Dairy protein blend 1 | Experimental | single oral administration Receives: Dietary Supplement: Dairy protein blend 1 |
| Whey protein | Experimental | Single oral administration Receives: Dietary Supplement: Whey protein |
| Dairy protein blend 2 | Experimental | Single oral administration Receives: Dietary Supplement: Dairy protein blend 2 |
| Dairy protein blend 3 | Experimental | Single oral administration Receives: Dietary Supplement: Dairy protein blend 3 |
| Dairy protein blend 4 | Experimental | Single oral administration Receives: Dietary Supplement: Dairy protein blend 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial serum amino acid concentration
Blood amino acid concentrations (mmol/L) before and at 13 time points (up till 5 hours) after consumption of the dairy products.
Measured: 0-300 min after consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start30 May 2018
- Primary completion5 Jul 2018
- Study completion5 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein Digestion KineticsStudies 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
- The study is designed as a randomized, single-blinded within-subject (cross-over) trial in which a group of 12 subjects receive 6 different dairy products.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- NIZO Food Research
- Sponsor type
- University, hospital or other
- Collaborators
- FrieslandCampina
- Responsible party
- Sponsor
- Investigators
- Melle van Schaik, Study director, NIZO Food Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547362
- Sponsor's protocol ID
- NL65184.072.18
- Acronym
- RAP
- Status last verified
- Jul 2018
- First submitted
- 20 Apr 2018
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Amino Acid Profiling
- ClinicalTrials.gov ID
- NCT03547362
- Acronym / sponsor ID
- RAP / NL65184.072.18
- Conditions
- Protein Digestion Kinetics
- Keywords
- Amino acids, Dairy proteins, Postprandial, Older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- NIZO Food ResearchUniversity, hospital or other
- Collaborators
- FrieslandCampina
- Study start
- 30 May 2018 (actual)
- Primary completion
- 5 Jul 2018 (actual)
- Study completion
- 5 Jul 2018 (actual)
- First posted
- 6 Jun 2018 (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.
This study was designed to obtain information about the effect of new combinations of dairy proteins, in small servings with high protein concentrations, on postprandial amino acid kinetics in blood in an older population.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- The study is designed as a randomized, single-blinded within-subject (cross-over) trial in which a group of 12 subjects receive 6 different dairy products.
| Arm | Type | Receives |
|---|---|---|
| Casein | Experimental | Dietary Supplement: CaseinSingle oral administration |
| Dairy protein blend 1 | Experimental | Dietary Supplement: Dairy protein blend 1single oral administration |
| Whey protein | Experimental | Dietary Supplement: Whey proteinSingle oral administration |
| Dairy protein blend 2 | Experimental | Dietary Supplement: Dairy protein blend 2Single oral administration |
| Dairy protein blend 3 | Experimental | Dietary Supplement: Dairy protein blend 3Single oral administration |
| Dairy protein blend 4 | Experimental | Dietary Supplement: Dairy protein blend 4Single oral administration |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Age ≥65 and ≤80
- BMI ≥20 and ≤32 kg/m2
- Non-smoking
- Healthy as assessed by the NIZO 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 the NIZO lifestyle and health questionnaire (3 main meals per day)
Key exclusion criteria (16 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 |
|---|---|---|
| CaseinSee arm description | Dietary supplement | Casein |
| Dairy protein blend 1See arm description | Dietary supplement | Dairy protein blend 1 |
| Whey proteinSee arm description | Dietary supplement | Whey protein |
| Dairy protein blend 2See arm description | Dietary supplement | Dairy protein blend 2 |
| Dairy protein blend 3See arm description | Dietary supplement | Dairy protein blend 3 |
| Dairy protein blend 4See arm description | Dietary supplement | Dairy protein blend 4 |
Primary outcome
Postprandial serum amino acid concentration
Time frame: 0-300 min after consumption
Blood amino acid concentrations (mmol/L) before and at 13 time points (up till 5 hours) after consumption of the dairy products.
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 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Melle van Schaik study director
NIZO Food Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Casein, Dairy protein blend 1 and Whey protein in people with Protein Digestion Kinetics, run by NIZO Food Research 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 16 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 Jul 2018. 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 serum amino acid concentration (time frame: 0-300 min after consumption). 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 11 Jul 2018.