Protein Synthesis OvernightPhase 1NCT02041143
Protein Intake on Muscle Protein Synthesis Overnight
A Phase 1 study testing Milk protein in people with Protein Synthesis Overnight, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
This trial is an exploratory study in order to determine whether the ingestion of one type of protein (milk protein/CHO/Fat) vs.placebo (CHO/Fat) 2 hours before bed time results in the extension of the post-prandial window of anabolism during the night by increasing whole body protein balance as well as muscle protein… Read more about this study
- Who is it for?
- Ages 55 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Protein Synthesis Overnight
- What is being tested?
- Milk protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2014to May 2014
- 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 55 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- Healthy as determined by the medical questionnaire and the medical visit including blood sampling
- 55-65y of age
- BMI (19.0 - 25.0 kg/ m²)
- Having signed the consent form
Who cannot join
- Digestive (intestinal, gastric, hepatic or pancreatic), renal or metabolic disease, as determined by the medical (screening) visit and a blood chemistry analysis (glucose, total cholesterol, LDL, HDL, triglycerides, aspartate transaminase, alanine aminotransferase, gamma glutamyl transpeptidase, C Reactive Protein, creatinin)
- Heart or other organ disease
- Arterial hypertension (Systolic pressure ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg)
- Any clotting trouble (diagnosed by Prothrombin time (PT), activated Partial Thromboplastin Time (aPTT), fibrinogen measures and platelets number (the latter is part of a classical blood cells counting at screening)
- Any inflammatory disease in the past four weeks
- Use of specific medications
Show all 19Show fewer
- Recent major surgery (3 months)
- History of major gastro-intestinal surgery (gastric bypass, intestinal resection etc…)
- History of cancer within the past year
- Significant weight loss during the last 3 months (5% and more)
- Food allergies, especially cow milk protein allergies
- Special diets especially vegetarian, high protein or weight loss program (anamnesis)
- Smokers
- High level structured exercise 3 times a week (e.g.: fitness club, competitions…)
- Have a high alcohol consumption (more than 2 drinks/day)
- Consumption of illicit drugs anamnesis only
- Having given blood within the last month, or willing to make a blood donation until one month following the end of the study
- Subject who cannot be expected to comply with the study procedures, including consuming the test products.
- Currently participating or having participated in another clinical trial during the last month prior to the beginning of this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Protein Intake on Muscle Protein Synthesis and Whole Body Protein Balance During an Overnight Fast: an Exploratory Study
This trial is an exploratory study in order to determine whether the ingestion of one type of protein (milk protein/CHO/Fat) vs.placebo (CHO/Fat) 2 hours before bed time results in the extension of the post-prandial window of anabolism during the night by increasing whole body protein balance as well as muscle protein fractional synthesis rate (FSR).
- Conditions
- Protein Synthesis Overnight
- Being tested
- Milk protein, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk proteinDietary supplement
Study product will provide 25 g of protein to subjects.
PlaceboDietary supplement
Product with no protein
| Study group | Role | What they receive |
|---|---|---|
| Milk protein | Experimental | Study product will provide 25 g of protein to subjects. One single supplement will be taken. Receives: Dietary Supplement: Placebo |
| Placebo | Placebo comparator | Placebo (no protein) Receives: Dietary Supplement: Milk protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle FSR determination
Muscle protein FSR (fractional synthesis rate) will be determined using primed constant infusions of [13C6] phenylalanine for 5 hours starting around from 03:00 a.m. (see flow chart attached). Whole body protein balance will be measured throughout the night using [15N]glycine (200mg) which will be orally taken with the trial product in the evening.
Measured: Within 24 hours of product intake
Secondary outcomes (3)
Activation of signaling pathways involved in skeletal muscle protein balance
Activation of signaling pathways involved in skeletal muscle protein balance will be assessed through use of immunohistochemistry
Measured: Within 24 hours after product intake
Glucose metabolism
Glucose metabolism will be assessed from circulating concentrations of glucose and insulin.
Measured: Within 24 hours after product intake
Plasma amino acid availability
The quantification of Free Amino Acids in Human Plasma will be done by Amino Acid Analyser Biochrome 30.
Measured: Within 24 hours after product intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2014
- Study completionMay 2014
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 Protein Synthesis OvernightStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041143
- Sponsor's protocol ID
- 13.19.MET
- Status last verified
- Oct 2015
- First submitted
- 16 Jan 2014
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Karagounis LG, Beaumont M, Donato-Capel L, Godin JP, Kapp AF, Draganidis D, Pinaud S, Vuichoud J, Shevlyakova M, Rade-Kukic K, Breuille D. Ingestion of a Pre-bedtime Protein Containing Beverage Prevents Overnight Induced Negative Whole Body Protein Balance in Healthy Middle-Aged Men: A Randomized Trial. Front Nutr. 2019 Nov 29;6:181. doi: 10.3389/fnut.2019.00181. eCollection 2019.
PubMed 31850360
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Protein Intake on Muscle Protein Synthesis and Whole Body Protein Balance During an Overnight Fast: an Exploratory Study
- ClinicalTrials.gov ID
- NCT02041143
- Acronym / sponsor ID
- 13.19.MET
- Conditions
- Protein Synthesis Overnight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 20 Jan 2014 (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.
This trial is an exploratory study in order to determine whether the ingestion of one type of protein (milk protein/CHO/Fat) vs.placebo (CHO/Fat) 2 hours before bed time results in the extension of the post-prandial window of anabolism during the night by increasing whole body protein balance as well as muscle protein fractional synthesis rate (FSR).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milk protein | Experimental | Dietary Supplement: PlaceboStudy product will provide 25 g of protein to subjects. One single supplement will be taken. |
| Placebo | Placebo comparator | Dietary Supplement: Milk proteinPlacebo (no protein) |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male
- Healthy as determined by the medical questionnaire and the medical visit including blood sampling
- 55-65y of age
- BMI (19.0 - 25.0 kg/ m²)
- Having signed the consent form
Key exclusion criteria (19 listed)
- Digestive (intestinal, gastric, hepatic or pancreatic), renal or metabolic disease, as determined by the medical (screening) visit and a blood chemistry analysis (glucose, total cholesterol, LDL, HDL, triglycerides, aspartate transaminase, alanine aminotransferase, gamma glutamyl transpeptidase, C Reactive Protein, creatinin)
- Heart or other organ disease
- Arterial hypertension (Systolic pressure ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg)
- Any clotting trouble (diagnosed by Prothrombin time (PT), activated Partial Thromboplastin Time (aPTT), fibrinogen measures and platelets number (the latter is part of a classical blood cells counting at screening)
- Any inflammatory disease in the past four weeks
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 proteinStudy product will provide 25 g of protein to subjects. | Dietary supplement | Placebo |
| PlaceboProduct with no protein | Dietary supplement | Milk protein |
Primary outcome
muscle FSR determination
Time frame: Within 24 hours of product intake
Muscle protein FSR (fractional synthesis rate) will be determined using primed constant infusions of [13C6] phenylalanine for 5 hours starting around from 03:00 a.m. (see flow chart attached). Whole body protein balance will be measured throughout the night using [15N]glycine (200mg) which will be orally taken with the trial product in the evening.
3 secondary outcomes
Activation of signaling pathways involved in skeletal muscle protein balance
Time frame: Within 24 hours after product intake
Glucose metabolism
Time frame: Within 24 hours after product intake
Plasma amino acid availability
Time frame: Within 24 hours after product intake
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 29 Oct 2015.
- Derived from this study: PubMed 31850360Karagounis LG, Beaumont M, Donato-Capel L, Godin JP, Kapp AF, Draganidis D, Pinaud S, Vuichoud J, Shevlyakova M, Rade-Kukic K, Breuille D. Ingestion of a Pre-bedtime Protein Containing Beverage Prevents Overnight Induced Negative Whole Body Protein Balance in Healthy Middle-Aged Men: A Randomized Trial. Front Nutr. 2019 Nov 29;6:181. doi: 10.3389/fnut.2019.00181. eCollection 2019.
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 Milk protein in people with Protein Synthesis Overnight, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
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 5 inclusion and 19 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 29 Oct 2015. 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 Switzerland. 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. 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.
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?
muscle FSR determination (time frame: Within 24 hours of product intake). 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 NCT02041143, 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 29 Oct 2015.