SarcopeniaPhase 1ArenANCT02013466
Amino Acid Bioavailability in Healthy Elderly After Intake of an Oral Nutritional Supplement
A Phase 1 study testing Bolus ONS A, Bolus ONS B and Bolus ONS C in people with Sarcopenia, run by Nutricia Research at 1 site in Netherlands.
Trial summary
In this study healthy older adults are requested to consume 4 different high-protein nutritional supplements. Each subject will visit the site 4 times and at every visit they will consume 1 of the 4 products after which a series of blood samples will be taken. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Bolus ONS A, Bolus ONS B and Bolus ONS C
- 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
- Oct 2008to Feb 2009
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65 years or older
- BMI between 21 and 30 kg/m2
Who cannot join
- Any condition that may interfere with the definition 'healthy elderly' according to the investigator's judgement.
- Any (history of) gastrointestinal disease that interferes with GI function (e.g. inflammatory bowel disease, gastroparesis, gastrectomy).
- Known allergy to milk and milk products.
- Known galactosaemia.
- Current or recent (within past three months) smoking.
- Known or suspected Diabetes Mellitus.
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- Current infection or fever in the last 7 days at the discretion of the physician.
- Use of antibiotics within 3 weeks of study entry.
- Current use of corticosteroids or hormones.
- Current use of antacids or any medication influencing gastric acid production.
- Requirement for any nutritional support.
- Unplanned body weight loss > 5% in the past 3-6 months.
- Adherence to any specific diet (e.g. weight loss, vegetarian).
- Use of protein containing or amino acid containing nutritional supplements within one week of study entry.
- Alcohol or drug abuse.
- Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements.
- Participation in any other study with investigational products concomitantly or within 4 weeks of study entry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Amino Acid Bioavailability in Healthy Elderly After Bolus Intake of a High Whey-protein, Leucine-rich, Low-caloric Oral Nutritional Supplement
In this study healthy older adults are requested to consume 4 different high-protein nutritional supplements. Each subject will visit the site 4 times and at every visit they will consume 1 of the 4 products after which a series of blood samples will be taken. The blood samples will be analyzed for amino acid bioavailability in the blood up to 4 hours after consumption.
- Conditions
- Sarcopenia
- Being tested
- Bolus ONS A, Bolus ONS B, Bolus ONS C, Bolus ONS D
- Keywords
- Bioavailability, Amino Acids, Elderly, Supplement
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bolus ONS ADietary supplement
High-whey protein, leucine-rich, low-caloric ONS in powder format
Bolus ONS BDietary supplement
High casein-protein, low-caloric control product (isocaloric to product A)
Bolus ONS CDietary supplement
High casein-protein, high-caloric control product.
Bolus ONS DDietary supplement
high whey-protein, leucine-rich, high-caloric control product (isocaloric to product C)
| Study group | Role | What they receive |
|---|---|---|
| Bolus ONS intake | Other | Bolus ONS A Bolus ONS B Bolus ONS C Bolus ONS D ONS = oral nutritional supplement 4-way cross-over design: Determination of the product order is based on a Latin square design. 3 Latin squares (4x4) are used, resulting in 12 unique product orders. Subjects receive a randomisation number corresponding with 1 of the 12 product orders. Study product labels will contain randomisation number and appropriate visit number. Receives: Dietary Supplement: Bolus ONS A; Dietary Supplement: Bolus ONS B; Dietary Supplement: Bolus ONS C; Dietary Supplement: Bolus ONS D |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome parameter in this study is the Maximum serum leucine concentration (Leumax) [micromol/L].
Measured: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Secondary outcomes (9)
Serum leucine incremental area under the curve (iAUC) [micromol/L*min].
Measured: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Time to reach half the serum leucine iAUC (t½) [minutes].
Measured: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Maximum serum essential amino acid concentration (EAAmax) [micromol/L]
Measured: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Maximum serum amino acid concentration (AAmax) [mmol/L]
Measured: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Maximum serum insulin concentration [micromol/L].
Measured: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Serum insulin iAUC [micromol/L*min]
Measured: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Maximum serum glucose concentration [mmol/L]
Measured: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Serum glucose iAUC [mmol/L*min]
Measured: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Adverse events and (Gastro-Intestinal) tolerance questionnaire.
Measured: During the study and until one week after completion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startOct 2008
- Primary completionFeb 2009
- Study completionFeb 2009
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 SarcopeniaStudies of the same condition, open and under way.
- More trials run by Nutricia ResearchThe sponsor's other registered studies.
- 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 1
- 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
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013466
- Sponsor's protocol ID
- Sip.1.C/B
- Acronym
- ArenA
- Status last verified
- Dec 2013
- First submitted
- 2 Dec 2013
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Luiking YC, Abrahamse E, Ludwig T, Boirie Y, Verlaan S. Protein type and caloric density of protein supplements modulate postprandial amino acid profile through changes in gastrointestinal behaviour: A randomized trial. Clin Nutr. 2016 Feb;35(1):48-58. doi: 10.1016/j.clnu.2015.02.013. Epub 2015 Mar 5.
PubMed 25790724
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amino Acid Bioavailability in Healthy Elderly After Bolus Intake of a High Whey-protein, Leucine-rich, Low-caloric Oral Nutritional Supplement
- ClinicalTrials.gov ID
- NCT02013466
- Acronym / sponsor ID
- ArenA / Sip.1.C/B
- Conditions
- Sarcopenia
- Keywords
- Bioavailability, Amino Acids, Elderly, Supplement
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 17 Dec 2013 (estimated)
- 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.
In this study healthy older adults are requested to consume 4 different high-protein nutritional supplements. Each subject will visit the site 4 times and at every visit they will consume 1 of the 4 products after which a series of blood samples will be taken. The blood samples will be analyzed for amino acid bioavailability in the blood up to 4 hours after consumption.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bolus ONS intake | Other | Dietary Supplement: Bolus ONS A, Dietary Supplement: Bolus ONS B, Dietary Supplement: Bolus ONS C, Dietary Supplement: Bolus ONS DBolus ONS A Bolus ONS B Bolus ONS C Bolus ONS D ONS = oral nutritional supplement 4-way cross-over design: Determination of the product order is based on a Latin square design. 3 Latin squares (4x4) are used, resulting in 12 unique product orders. Subjects receive a randomisation number corresponding with 1 of the 12 product orders. Study product labels will contain randomisation number and appropriate visit number. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age 65 years or older
- BMI between 21 and 30 kg/m2
Key exclusion criteria (17 listed)
- Any condition that may interfere with the definition 'healthy elderly' according to the investigator's judgement.
- Any (history of) gastrointestinal disease that interferes with GI function (e.g. inflammatory bowel disease, gastroparesis, gastrectomy).
- Known allergy to milk and milk products.
- Known galactosaemia.
- Current or recent (within past three months) smoking.
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 |
|---|---|---|
| Bolus ONS AHigh-whey protein, leucine-rich, low-caloric ONS in powder format | Dietary supplement | Bolus ONS intake |
| Bolus ONS BHigh casein-protein, low-caloric control product (isocaloric to product A) | Dietary supplement | Bolus ONS intake |
| Bolus ONS CHigh casein-protein, high-caloric control product. | Dietary supplement | Bolus ONS intake |
| Bolus ONS Dhigh whey-protein, leucine-rich, high-caloric control product (isocaloric to product C) | Dietary supplement | Bolus ONS intake |
Primary outcome
The primary outcome parameter in this study is the Maximum serum leucine concentration (Leumax) [micromol/L].
Time frame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
9 secondary outcomes
Serum leucine incremental area under the curve (iAUC) [micromol/L*min].
Time frame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Time to reach half the serum leucine iAUC (t½) [minutes].
Time frame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Maximum serum essential amino acid concentration (EAAmax) [micromol/L]
Time frame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Maximum serum amino acid concentration (AAmax) [mmol/L]
Time frame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Maximum serum insulin concentration [micromol/L].
Time frame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Serum insulin iAUC [micromol/L*min]
Time frame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Maximum serum glucose concentration [mmol/L]
Time frame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Serum glucose iAUC [mmol/L*min]
Time frame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)
Adverse events and (Gastro-Intestinal) tolerance questionnaire.
Time frame: During the study and until one week after completion of the study
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 17 Dec 2013.
- Derived from this study: PubMed 25790724Luiking YC, Abrahamse E, Ludwig T, Boirie Y, Verlaan S. Protein type and caloric density of protein supplements modulate postprandial amino acid profile through changes in gastrointestinal behaviour: A randomized trial. Clin Nutr. 2016 Feb;35(1):48-58. doi: 10.1016/j.clnu.2015.02.013. Epub 2015 Mar 5.
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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 Phase 1 study testing Bolus ONS A, Bolus ONS B and Bolus ONS C in people with Sarcopenia, run by Nutricia 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 2 inclusion and 17 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 17 Dec 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary outcome parameter in this study is the Maximum serum leucine concentration (Leumax) [micromol/L]. (time frame: Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)). 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 NCT02013466, 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 17 Dec 2013.