Focus: Anabolic Response to Food Intake in Young IndividualsPRO-ADAPTNCT01820975
Manipulation of Dietary Protein and the Anabolic Response
A study testing High protein intake in people with Focus: Anabolic Response to Food Intake in Young Individuals and Condition Relevance: Skeletal Muscle Health, Sarcopenia, run by Maastricht University Medical Center.
Trial summary
In the present study, the effect of habitual dietary protein on the anabolic response will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Focus: Anabolic Response to Food Intake in Young Individuals, Condition Relevance: Skeletal Muscle Health, Sarcopenia
- What is being tested?
- High protein intake
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to 1 Feb 2017
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males
- Aged between 18-35 years
- Healthy, recreationally active
- BMI < 30 kg/m2
Who cannot join
- Smoking
- Allergies to milk proteins (whey or casein)
- Vegetarians
- Diagnosed GI tract diseases
- Female
- Arthritic conditions
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- A history of neuromuscular problems
- Previous participation in amino acid tracer studies
- Individuals on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications
About this study
Official title: The Manipulation of Dietary Protein Intake on the Anabolic Response in Healthy Young Men
In the present study, the effect of habitual dietary protein on the anabolic response will be investigated.
- Conditions
- Focus: Anabolic Response to Food Intake in Young Individuals, Condition Relevance: Skeletal Muscle Health, Sarcopenia
- Being tested
- High protein intake, Placebo comparator
- Keywords
- Muscle protein synthesis, Dietary protein
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High protein intakeDietary supplement
Placebo comparatorOther
Also called control group
No protein intake
| Study group | Role | What they receive |
|---|---|---|
| High protein intake | Experimental | High protein intake: large bolus of protein in teh diet the day before testing Receives: Dietary Supplement: High protein intake |
| No protein intake | Placebo comparator | No protein in the diet the day before testing Receives: Other: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein fractional synthetic rate following protein ingestion
The ability of the muscle to synthesise new proteins will be assessed over a 3 h period following protein ingestion and will be compared between groups. This only occurs on one occasion.
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 posted29 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionMar 2015
- Study completion1 Feb 2017
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 Focus: Anabolic Response to Food Intake in Young IndividualsStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc JC van Loon, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820975
- Sponsor's protocol ID
- METC 12-3-067
- Acronym
- PRO-ADAPT
- Status last verified
- May 2015
- First submitted
- 18 Mar 2013
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gorissen SHM, Trommelen J, Kouw IWK, Holwerda AM, Pennings B, Groen BBL, Wall BT, Churchward-Venne TA, Horstman AMH, Koopman R, Burd NA, Fuchs CJ, Dirks ML, Res PT, Senden JMG, Steijns JMJM, de Groot LCPGM, Verdijk LB, van Loon LJC. Protein Type, Protein Dose, and Age Modulate Dietary Protein Digestion and Phenylalanine Absorption Kinetics and Plasma Phenylalanine Availability in Humans. J Nutr. 2020 Aug 1;150(8):2041-2050. doi: 10.1093/jn/nxaa024.
PubMed 32069356
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Manipulation of Dietary Protein Intake on the Anabolic Response in Healthy Young Men
- ClinicalTrials.gov ID
- NCT01820975
- Acronym / sponsor ID
- PRO-ADAPT / METC 12-3-067
- Conditions
- Focus: Anabolic Response to Food Intake in Young Individuals, Condition Relevance: Skeletal Muscle Health, Sarcopenia
- Keywords
- Muscle protein synthesis, Dietary protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 29 Mar 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 the present study, the effect of habitual dietary protein on the anabolic response will be investigated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High protein intake | Experimental | Dietary Supplement: High protein intakeHigh protein intake: large bolus of protein in teh diet the day before testing |
| No protein intake | Placebo comparator | Other: Placebo comparatorNo protein in the diet the day before testing |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males
- Aged between 18-35 years
- Healthy, recreationally active
- BMI < 30 kg/m2
Key exclusion criteria (9 listed)
- Smoking
- Allergies to milk proteins (whey or casein)
- Vegetarians
- Diagnosed GI tract diseases
- Female
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 |
|---|---|---|
| High protein intake | Dietary supplement | High protein intake |
| Placebo comparatorAlso: control groupNo protein intake | Other | No protein intake |
Primary outcome
Muscle protein fractional synthetic rate following protein ingestion
Time frame: 3 hours
The ability of the muscle to synthesise new proteins will be assessed over a 3 h period following protein ingestion and will be compared between groups. This only occurs on one occasion.
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 22 Mar 2017.
- Derived from this study: PubMed 32069356Gorissen SHM, Trommelen J, Kouw IWK, Holwerda AM, Pennings B, Groen BBL, Wall BT, Churchward-Venne TA, Horstman AMH, Koopman R, Burd NA, Fuchs CJ, Dirks ML, Res PT, Senden JMG, Steijns JMJM, de Groot LCPGM, Verdijk LB, van Loon LJC. Protein Type, Protein Dose, and Age Modulate Dietary Protein Digestion and Phenylalanine Absorption Kinetics and Plasma Phenylalanine Availability in Humans. J Nutr. 2020 Aug 1;150(8):2041-2050. doi: 10.1093/jn/nxaa024.
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.
Luc JC van Loon, PhD principal investigator
Maastricht University
Questions about this trial
What is this clinical trial studying?
A study testing High protein intake in people with Focus: Anabolic Response to Food Intake in Young Individuals and Condition Relevance: Skeletal Muscle Health, Sarcopenia, run by Maastricht University Medical Center.
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 9 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 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Muscle protein fractional synthetic rate following protein ingestion (time frame: 3 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 NCT01820975, 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 22 Mar 2017.