Protein UtilizationFONDAANCT02587156
Fate of Nutrient-Derived Amino Acids, FONDAA
A study testing Meal serving at high dietary protein, Meal serving at low dietary protein and Meal serving in people with Protein Utilization and Dietary Protein, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
12 elderly (65-70 years of age) male subjects will be included and complete a double blinded cross-over study. They will be habituated for 21 days to either low or high protein intake (below 0.8 g/kg or above 1.5 g/kg, respectively). Following a 45 day washout period they will switch to the alternate group. Read more about this study
- Who is it for?
- Ages 65 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Protein Utilization, Dietary Protein
- What is being tested?
- Meal serving at high dietary protein, Meal serving at low dietary protein and Meal serving
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2015to 8 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 65 to 70 years
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Males age 65-70
- Independently dwelling
- Without any major health issues (blood pressure, cholesterol and lipid profile will be measured and evaluated by a physician)
- Non-diabetic
- No organ disease
- No back pain
Show all 9Show fewer
- Not regularly take any prescription drugs or dietary supplements, which can influence muscle protein synthesis
- Alcohol intake below 21 units pr. week
- No known arthrosclerosis
Who cannot join
- Hyperlipidemia
- Hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fate of Nutrient-Derived Amino Acids: Influence of Habituated Levels of Daily Dietary Protein Intake on Protein Utilization
12 elderly (65-70 years of age) male subjects will be included and complete a double blinded cross-over study. They will be habituated for 21 days to either low or high protein intake (below 0.8 g/kg or above 1.5 g/kg, respectively). Following a 45 day washout period they will switch to the alternate group. At the end of each habituation period, the investigators will measure the appearance of labelled amino acids from milk proteins.
- Conditions
- Protein Utilization, Dietary Protein
- Being tested
- Meal serving at high dietary protein, Meal serving at low dietary protein, Meal serving
- Keywords
- Required dietary protein, Amino acid, Splanchnic extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal serving at high dietary proteinDietary supplement
Participants are habituated to a high level of dietary protein intake for 21 days.
Meal serving at low dietary proteinDietary supplement
Participants are habituated to a low level of dietary protein intake for 21 days.
Meal servingDietary supplement
To investigate impact of habituated protein level
| Study group | Role | What they receive |
|---|---|---|
| Meal serving at high dietary protein | Experimental | Test the handling of meal-served protein when habituated to high dietary protein at an amount above 1.5 g protein/kg/day Receives: Dietary Supplement: Meal serving at high dietary protein; Dietary Supplement: Meal serving |
| Meal serving at low dietary protein | Active comparator | Test the handling of meal-served protein when habituated to high dietary protein at an amount below 0.8 g protein/kg/day Receives: Dietary Supplement: Meal serving at low dietary protein; Dietary Supplement: Meal serving |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abundance of milk protein-bound amino acid labels in blood protein.
Related to the trials conducted after 21 days of habituation to either high or low protein in the diet:
After intake of milk proteins at time 0 (zero) the quantity of intrinsic labels D5-phe from whey and 15N-phe from casein will be measured in liver-synthesized blood protein at 240 min.
Measured: Baseline to 240 min postprandial
Secondary outcomes (10)
Abundance of milk protein-bound amino acid labels in myofibrillar protein.
Related to the trials conducted after 21 days of habituation to either high or low protein in the diet:
After intake of milk proteins at time 0 (zero) the quantity of intrinsic labels D5-phe from whey and 15N-phe from casein will be measured in myofibrillar protein at 240 min.
Measured: Baseline to 240 min postprandial
Leg phenylalanine rate of disappearance and appearance, net balance.
Related to the trials conducted after 21 days of habituation to either high or low protein in the diet:
From arterial and femoral venous blood samples obtained at baseline, 30, 60, 90, 120, 150, 180, 240 min phenylalanine tracer enrichments and concentrations as well as plasma flow will be measured.
Measured: Baseline to 240 min postprandial
First pass splanchnic extraction of dietary protein-derived labeled phenylalanine.
Related to the trials conducted after 21 days of habituation to either high or low protein in the diet:
From hepatic venous blood samples obtained at baseline, 30, 60, 90, 120, 150, 180, 240 min phenylalanine tracer enrichments and concentrations as well as plasma flow will be measured. Knowing the amount of ingested protein and labeled phenylalanine we can calculate the first pass splanchnic amino acid extraction.
Measured: Baseline to 240 min postprandial
Whole body phenylalanine rate of disappearance and appearance, net balance.
Related to the trials conducted after 21 days of habituation to either high or low protein in the diet:
From blood samples obtained at baseline, 30, 60, 90, 120, 150, 180, 240 min phenylalanine tracer enrichments will be measured.
Measured: Baseline to 240 min postprandial
The myofibrillar protein fractional synthesis rate
Related to the trials conducted after 21 days of habituation to either high or low protein in the diet:
From muscle biopsies obtained at baseline, 60 and 240 min the abundance of phenylalanine tracer bound in the myofibrillar proteins will be measured and the fractional synthesis rate will be measured within the first from baseline to 60 min and 240 min as well as from 60-240 min postprandial.
Measured: Baseline to 240 min postprandial
Response of expression of proteins involved in muscle protein turnover
Related to the trials conducted after 21 days of habituation to either high or low protein in the diet:
From baseline to 60 and 240 min after intake of the standardized meal after 21 days of habituation to either a high or a low dietary protein intake expression of signalling proteins related to protein turnover in the muscle will be measured by use of western blotting.
Measured: Baseline, 60 min and 240 min postprandial
Urea production.
Related to the trials conducted after 21 days of habituation to either high or low protein in the diet:
From blood samples obtained at baseline, 30, 60, 90, 120, 150, 180, 240 min urea tracer enrichments and concentrations will be measured. With this, and flow measurements, we can determine the rate of urea production.
Measured: Baseline to 240 min postprandial
Nitrogen and creatinine excreted in urine
Related to the adaptation to the 21 day habituation period to either high or low protein in the diet as well as the response to the standardized trial meal:
Nitrogen and creatinine content is measured in urine is collected for the last 24 h of the 21 day habituation period, as well as during the 240 min trial day and the remaining 20 hours of the trial day.
Measured: 21 days post intervention, 240 min postprandial and 24 hours post the day 21 trial day
Fecal microbiota composition
Related to the adaptation to the 21 day habituation period to either high or low protein in the diet as well as the response to the standardized trial meal:
The microbiota compositions, will be measured in fecal samples collected before the 21 day habituation period, after the 21 day habituation periode, as well as after the 240 min trial day
Measured: Change from pre-intervention to 21 days and 22 days (21 intervention days habituation and the standardized trial meal on day 21)
Adaptation of expression of proteins involved in muscle protein turnover
Related to the adaptation to the 21 day habituation period to either high or low protein in the diet:
Biopsies taken following the two 21 day habituation period will, by use of western blotting, be analysed for expression of signalling proteins involved in muscle protein turnover.
Measured: After 21 days of habituation to either a high or a low dietary protein intake.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startOct 2015
- Primary completion8 Feb 2018
- Study completion8 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 UtilizationStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grith Højfeldt, Bispebjerg Hospital
- Investigators
- Grith Højfeldt, M.Sc., Principal investigator, Bispebjerg HospitalLars Holm, Ph.D., Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587156
- Sponsor's protocol ID
- BBH122
- Acronym
- FONDAA
- Status last verified
- Mar 2018
- First submitted
- 22 Oct 2015
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Hojfeldt G, Bulow J, Agergaard J, Asmar A, Schjerling P, Simonsen L, Bulow J, van Hall G, Holm L. Impact of habituated dietary protein intake on fasting and postprandial whole-body protein turnover and splanchnic amino acid metabolism in elderly men: a randomized, controlled, crossover trial. Am J Clin Nutr. 2020 Dec 10;112(6):1468-1484. doi: 10.1093/ajcn/nqaa201.
PubMed 32710741
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fate of Nutrient-Derived Amino Acids: Influence of Habituated Levels of Daily Dietary Protein Intake on Protein Utilization
- ClinicalTrials.gov ID
- NCT02587156
- Acronym / sponsor ID
- FONDAA / BBH122
- Conditions
- Protein Utilization, Dietary Protein
- Keywords
- Required dietary protein, Amino acid, Splanchnic extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- 8 Feb 2018 (actual)
- Study completion
- 8 Feb 2018 (actual)
- First posted
- 27 Oct 2015 (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.
12 elderly (65-70 years of age) male subjects will be included and complete a double blinded cross-over study. They will be habituated for 21 days to either low or high protein intake (below 0.8 g/kg or above 1.5 g/kg, respectively). Following a 45 day washout period they will switch to the alternate group. At the end of each habituation period, the investigators will measure the appearance of labelled amino acids from milk proteins.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meal serving at high dietary protein | Experimental | Dietary Supplement: Meal serving at high dietary protein, Dietary Supplement: Meal servingTest the handling of meal-served protein when habituated to high dietary protein at an amount above 1.5 g protein/kg/day |
| Meal serving at low dietary protein | Active comparator | Dietary Supplement: Meal serving at low dietary protein, Dietary Supplement: Meal servingTest the handling of meal-served protein when habituated to high dietary protein at an amount below 0.8 g protein/kg/day |
Who may qualify
- Ages
- 65 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Males age 65-70
- Independently dwelling
- Without any major health issues (blood pressure, cholesterol and lipid profile will be measured and evaluated by a physician)
- Non-diabetic
- No organ disease
Key exclusion criteria (2 listed)
- Hyperlipidemia
- Hypertension
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 |
|---|---|---|
| Meal serving at high dietary proteinParticipants are habituated to a high level of dietary protein intake for 21 days. | Dietary supplement | Meal serving at high dietary protein |
| Meal serving at low dietary proteinParticipants are habituated to a low level of dietary protein intake for 21 days. | Dietary supplement | Meal serving at low dietary protein |
| Meal servingTo investigate impact of habituated protein level | Dietary supplement | Meal serving at high dietary protein, Meal serving at low dietary protein |
Primary outcome
Abundance of milk protein-bound amino acid labels in blood protein.
Time frame: Baseline to 240 min postprandial
Related to the trials conducted after 21 days of habituation to either high or low protein in the diet: After intake of milk proteins at time 0 (zero) the quantity of intrinsic labels D5-phe from whey and 15N-phe from casein will be measured in liver-synthesized blood protein at 240 min.
10 secondary outcomes
Abundance of milk protein-bound amino acid labels in myofibrillar protein.
Time frame: Baseline to 240 min postprandial
Leg phenylalanine rate of disappearance and appearance, net balance.
Time frame: Baseline to 240 min postprandial
First pass splanchnic extraction of dietary protein-derived labeled phenylalanine.
Time frame: Baseline to 240 min postprandial
Whole body phenylalanine rate of disappearance and appearance, net balance.
Time frame: Baseline to 240 min postprandial
The myofibrillar protein fractional synthesis rate
Time frame: Baseline to 240 min postprandial
Response of expression of proteins involved in muscle protein turnover
Time frame: Baseline, 60 min and 240 min postprandial
Urea production.
Time frame: Baseline to 240 min postprandial
Nitrogen and creatinine excreted in urine
Time frame: 21 days post intervention, 240 min postprandial and 24 hours post the day 21 trial day
Fecal microbiota composition
Time frame: Change from pre-intervention to 21 days and 22 days (21 intervention days habituation and the standardized trial meal on day 21)
Adaptation of expression of proteins involved in muscle protein turnover
Time frame: After 21 days of habituation to either a high or a low dietary protein 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 5 Mar 2018.
- Derived from this study: PubMed 32710741Hojfeldt G, Bulow J, Agergaard J, Asmar A, Schjerling P, Simonsen L, Bulow J, van Hall G, Holm L. Impact of habituated dietary protein intake on fasting and postprandial whole-body protein turnover and splanchnic amino acid metabolism in elderly men: a randomized, controlled, crossover trial. Am J Clin Nutr. 2020 Dec 10;112(6):1468-1484. doi: 10.1093/ajcn/nqaa201.
- Individual participant dataSharing planned: Undecided
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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.
Grith Højfeldt, M.Sc. principal investigator
Bispebjerg Hospital
Lars Holm, Ph.D. principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal serving at high dietary protein, Meal serving at low dietary protein and Meal serving in people with Protein Utilization and Dietary Protein, run by Bispebjerg Hospital 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 9 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 5 Mar 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 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?
Abundance of milk protein-bound amino acid labels in blood protein. (time frame: Baseline to 240 min postprandial). 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 NCT02587156, 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 5 Mar 2018.