Protein MetabolismNCT03326284
Optimal Protein Dose Per Meal During Weight Loss in Perspective to Maintaining Muscle Mass
A study testing 15 g protein hypocaloric, 35 g protein hypocaloric and 60 g protein hypocaloric in people with Protein Metabolism, run by University of Aarhus at 1 site in Denmark.
Trial summary
The primary aim of the trial is to determine the optimal dose of protein per meal in relation to enhancing muscle protein synthesis and thereby in perspective counteract muscle loss during weight loss. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Protein Metabolism
- What is being tested?
- 15 g protein hypocaloric, 35 g protein hypocaloric and 60 g protein hypocaloric
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2017to 1 Feb 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 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy
- Postmenopausal women
Who cannot join
- Smoking
- Metabolic and/or chronic diseases
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University, Department for Public Health, Section for Sport Science
Aarhus, 8000
About this study
Official title: Optimizing Per Meal Protein Intake During Weight Loss
The primary aim of the trial is to determine the optimal dose of protein per meal in relation to enhancing muscle protein synthesis and thereby in perspective counteract muscle loss during weight loss. In addition, we aim to determine whether the response to protein intake is reduced in women on hypocaloric diet compared to in women on an energy-balanced diet.
Read the detailed description
Aim of this project is to determine the optimal protein dose (high quality milk protein) per meal in relation to enhancing muscle protein synthesis and thereby counteract muscle loss during weight loss.
The hypothesis is that the optimum dose of protein for women on a hypocaloric diet will be greater than when women eat an energy sufficient diet, and also higher than the optimal dose previously determined in weight stable men.
Methods: Forty women (~ 50 years) will be randomized to four groups. Following a five day hypocaloric diet (three groups) or an energy balanced diet (one group). The women will report to the laboratory to ingest one of three different protein doses. The muscle protein response to the different doses of protein will be determined by the muscle protein fractional synthetic rates using tracer kinetics.
- Conditions
- Protein Metabolism
- Being tested
- 15 g protein hypocaloric, 35 g protein hypocaloric, 60 g protein hypocaloric, 35 g protein energy balance
- Keywords
- Hypocaloric diet, Dietary protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15 g protein hypocaloricOther
Following a 5 day hypocaloric diet one group of 10 women will ingest 15 g of protein
35 g protein hypocaloricOther
Following a 5 day hypocaloric diet one group of 10 women will ingest 35 g of protein
60 g protein hypocaloricOther
Following a 5 day hypocaloric diet one group of 10 women will ingest 60 g of protein
35 g protein energy balanceOther
Following a 5 day energy balanced diet one group of 10 women will ingest 35 g of protein
| Study group | Role | What they receive |
|---|---|---|
| 15g protein hypocaloric diet | Experimental | Following a 5-day hypocaloric diet the subjects (n=10) will ingest 15g of protein and their mixed muscle protein synthesis response will be monitored using tracer kinetics. Receives: Other: 15 g protein hypocaloric |
| 35g protein hypocaloric diet | Experimental | Following a 5-day hypocaloric diet the subjects (n=10) will ingest 35g of protein and their mixed muscle protein synthesis response will be monitored using tracer kinetics. Receives: Other: 35 g protein hypocaloric |
| 60g protein hypocaloric diet | Experimental | Following a 5-day hypocaloric diet the subjects (n=10) will ingest 60g of protein and their mixed muscle protein synthesis response will be monitored using tracer kinetics. Receives: Other: 60 g protein hypocaloric |
| 35g protein energy balanced diet | Experimental | Following a 5-day energy balanced diet the subjects (n=10) will ingest 35g of protein and their mixed muscle protein synthesis response will be monitored using tracer kinetics. Receives: Other: 35 g protein energy balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional synthetic rate
Mixed muscle protein synthetic rate determined by tracer kinetics
Measured: 3 hours after ingestion of protein
Secondary outcomes (1)
Muscle signalling
Markers for myofibrillar protein turnover measured by RT-PCR and western blotting
Measured: 3 hours after ingestion of protein.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start1 Aug 2017
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
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 MetabolismStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- : Forty women (\~ 50 years) will be randomized to four groups. Following a five day hypocaloric diet (three groups) or an energy balanced diet (one group). The women will report to the laboratory to ingest one of three different protein doses.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Arla Foods, Innovation foundation, Mejeribrugets ForskningsFond
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326284
- Sponsor's protocol ID
- 57403
- Status last verified
- Jun 2018
- First submitted
- 8 May 2017
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Larsen MS, Witard OC, Holm L, Scaife P, Hansen R, Smith K, Tipton KD, Mose M, Bengtsen MB, Lauritsen KM, Mikkelsen UR, Hansen M. Dose-Response of Myofibrillar Protein Synthesis To Ingested Whey Protein During Energy Restriction in Overweight Postmenopausal Women: A Randomized, Controlled Trial. J Nutr. 2023 Nov;153(11):3173-3184. doi: 10.1016/j.tjnut.2023.08.011. Epub 2023 Aug 19.
PubMed 37598750
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Per Meal Protein Intake During Weight Loss
- ClinicalTrials.gov ID
- NCT03326284
- Acronym / sponsor ID
- 57403
- Conditions
- Protein Metabolism
- Keywords
- Hypocaloric diet, Dietary protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Arla Foods, Innovation foundation, Mejeribrugets ForskningsFond
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 31 Oct 2017 (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.
The primary aim of the trial is to determine the optimal dose of protein per meal in relation to enhancing muscle protein synthesis and thereby in perspective counteract muscle loss during weight loss. In addition, we aim to determine whether the response to protein intake is reduced in women on hypocaloric diet compared to in women on an energy-balanced diet.
Detailed description
Aim of this project is to determine the optimal protein dose (high quality milk protein) per meal in relation to enhancing muscle protein synthesis and thereby counteract muscle loss during weight loss.
The hypothesis is that the optimum dose of protein for women on a hypocaloric diet will be greater than when women eat an energy sufficient diet, and also higher than the optimal dose previously determined in weight stable men.
Methods: Forty women (~ 50 years) will be randomized to four groups. Following a five day hypocaloric diet (three groups) or an energy balanced diet (one group). The women will report to the laboratory to ingest one of three different protein doses. The muscle protein response to the different doses of protein will be determined by the muscle protein fractional synthetic rates using tracer kinetics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- : Forty women (~ 50 years) will be randomized to four groups. Following a five day hypocaloric diet (three groups) or an energy balanced diet (one group). The women will report to the laboratory to ingest one of three different protein doses.
| Arm | Type | Receives |
|---|---|---|
| 15g protein hypocaloric diet | Experimental | Other: 15 g protein hypocaloricFollowing a 5-day hypocaloric diet the subjects (n=10) will ingest 15g of protein and their mixed muscle protein synthesis response will be monitored using tracer kinetics. |
| 35g protein hypocaloric diet | Experimental | Other: 35 g protein hypocaloricFollowing a 5-day hypocaloric diet the subjects (n=10) will ingest 35g of protein and their mixed muscle protein synthesis response will be monitored using tracer kinetics. |
| 60g protein hypocaloric diet | Experimental | Other: 60 g protein hypocaloricFollowing a 5-day hypocaloric diet the subjects (n=10) will ingest 60g of protein and their mixed muscle protein synthesis response will be monitored using tracer kinetics. |
| 35g protein energy balanced diet | Experimental | Other: 35 g protein energy balanceFollowing a 5-day energy balanced diet the subjects (n=10) will ingest 35g of protein and their mixed muscle protein synthesis response will be monitored using tracer kinetics. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy
- Postmenopausal women
Key exclusion criteria (2 listed)
- Smoking
- Metabolic and/or chronic diseases
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 |
|---|---|---|
| 15 g protein hypocaloricFollowing a 5 day hypocaloric diet one group of 10 women will ingest 15 g of protein | Other | 15g protein hypocaloric diet |
| 35 g protein hypocaloricFollowing a 5 day hypocaloric diet one group of 10 women will ingest 35 g of protein | Other | 35g protein hypocaloric diet |
| 60 g protein hypocaloricFollowing a 5 day hypocaloric diet one group of 10 women will ingest 60 g of protein | Other | 60g protein hypocaloric diet |
| 35 g protein energy balanceFollowing a 5 day energy balanced diet one group of 10 women will ingest 35 g of protein | Other | 35g protein energy balanced diet |
Primary outcome
Fractional synthetic rate
Time frame: 3 hours after ingestion of protein
Mixed muscle protein synthetic rate determined by tracer kinetics
1 secondary outcome
Muscle signalling
Time frame: 3 hours after ingestion of protein.
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 31 Jul 2019.
- Derived from this study: PubMed 37598750Larsen MS, Witard OC, Holm L, Scaife P, Hansen R, Smith K, Tipton KD, Mose M, Bengtsen MB, Lauritsen KM, Mikkelsen UR, Hansen M. Dose-Response of Myofibrillar Protein Synthesis To Ingested Whey Protein During Energy Restriction in Overweight Postmenopausal Women: A Randomized, Controlled Trial. J Nutr. 2023 Nov;153(11):3173-3184. doi: 10.1016/j.tjnut.2023.08.011. Epub 2023 Aug 19.
- 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.
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 15 g protein hypocaloric, 35 g protein hypocaloric and 60 g protein hypocaloric in people with Protein Metabolism, run by University of Aarhus at 1 site in Denmark.
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 2 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 31 Jul 2019. 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 Denmark. 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?
Fractional synthetic rate (time frame: 3 hours after ingestion of protein). 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 NCT03326284, 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 31 Jul 2019.