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AzTrials

SarcopeniaPro-FatNCT01680146

Impact of Fat Co-ingestion With Protein on the Post-prandial Anabolic Response in Elderly Men

A study testing PRO+FAT and PRO in people with Sarcopenia, run by Maastricht University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Rationale: The progressive loss of skeletal muscle mass with aging, or sarcopenia, has a major impact on our healthcare system due to increased morbidity and greater need for hospitalization and/or institutionalization. One way to prevent skeletal muscle loss is to improve dietary intake of the elderly. Read more about this study

Who is it for?
Ages 55 to 85 years, men onlyHealthy volunteers can take part
Conditions the study is for
Sarcopenia
What is being tested?
PRO+FAT and PRO
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteNetherlands
Study dates
Oct 2012to Dec 2012
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 55 to 85 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy males
  • Age between 55 and 85
  • BMI < 30 kg/m2

Who cannot join

  • Glucose intolerance
  • Milk and/or fat intolerance
  • Smoking
  • Diagnosed GI tract diseases
  • Arthritic conditions
  • A history of neuromuscular problems
Show all 10Show fewer
  • Any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications).
  • Use of anticoagulants
  • Participation in exercise program
  • Hypertension, high blood pressure that is above 140/90 mmHg.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site
  • Maastricht University

    Maastricht, Limburg, 6200 MD

Other trials in Netherlands

About this study

Official title: Impact of Fat Co-ingestion With Protein on the Post-prandial Anabolic Response in Elderly Men (Pro-Fat Study)

Rationale: The progressive loss of skeletal muscle mass with aging, or sarcopenia, has a major impact on our healthcare system due to increased morbidity and greater need for hospitalization and/or institutionalization. One way to prevent skeletal muscle loss is to improve dietary intake of the elderly. It has already been shown that ingestion of dietary protein stimulates muscle protein synthesis and inhibits muscle protein breakdown, resulting in an overall positive net protein balance. However, the impact of fat (as part of the meal) on dietary protein-induced muscle protein synthesis remains largely unknown. Based on previous studies by other research groups, we hypothesize that fat further stimulates the muscle anabolic response to protein ingestion.

Objective: The primary objective of this study is to investigate the effect of a single meal-like amount of protein with or without fat on postprandial muscle protein synthesis rates in healthy elderly men. Furthermore, as a secondary objective, we will assess digestion and absorption kinetics.

Read more

Study design: double-blind randomized intervention study Study population: 24 healthy elderly men (55-85 y) Intervention: one group (n=12) will consume a test beverage of 350 mL containing 20 g of intrinsically labeled casein, and the other group (n=12) will consume a beverage of the same volume containing 20 g of casein plus 20 g of fat.

Main study parameters/endpoints: Primary endpoint: muscle protein synthesis rates. Secondary endpoint: digestion and absorption kinetics.

Read the detailed description

The progressive loss of skeletal muscle mass with aging, or sarcopenia, has a major impact on our healthcare system due to increased morbidity and greater need for hospitalization and/or institutionalization. The age-related loss of skeletal muscle mass is facilitated by a combination of factors, which include a less than optimal diet and a sedentary lifestyle. These factors contribute to a disruption in the regulation of skeletal muscle protein turnover, leading to an imbalance between muscle protein synthesis (MPS) and degradation. One way to overcome this problem is to improve dietary intake of the elderly. It has been well established that nutrient intake greatly affects protein turnover in skeletal muscle tissue.

Ingestion of dietary protein stimulates MPS rates and inhibits muscle protein breakdown rates, resulting in an overall positive net protein balance in both the young and elderly. However, it is not clear what the impact is of co-ingestion of other macronutrients on digestion and absorption kinetics or MPS rates in the healthy young or the elderly. We have recently conducted a study to examine the impact of carbohydrate co-ingestion on postprandial MPS in the healthy young and old. Indeed, preliminary results show that carbohydrate co-ingestion stimulates protein synthesis.

Interestingly, very little is known about the impact of fat co-ingestion with protein on the stimulation of post-prandial MPS rates. What is noteworthy is that Elliot et al. investigated the effect of whole milk ingestion on net muscle protein balance after resistance exercise using an arteriovenous balance approach. Ingestion of whole milk (containing 50 en% fats) stimulated the post-exercise net uptake of phenylalanine and threonine to a greater extent than ingestion of fat-free milk (containing 6 en% fat). Although, amino acid uptake is indicative of 'muscle anabolism', it is not a direct measure of MPS so no firm conclusions can be deduce from this work. Furthermore, milk also contains a certain amount of carbohydrates (fat-free milk 55 en% and whole milk 30 en%), which does not allow for direct assessment of fat co-ingestion per se.

Certainly, other studies have investigated the effect of long term fatty acid intake, using direct incorporation methods, on the MPS rates. For example, long term omega-3 polyunsaturated fatty acid (n-3 PUFA) supplementation increased feeding-mediated MPS rates in young, middle-aged, and older adults. The mechanism(s) underpinning the enhanced effect of n-3 PUFA supplementation on post-prandial MPS rates to dietary protein are not well defined. It has been speculated that the enhanced feeding-effect of n-3 PUFA on postprandial MPS rates is due to remodeling of the sarcolemma to include a greater n-3 PUFA content, and ultimately enhances insulin's action on muscle protein metabolism. This is clearly a long term effect, but what about the acute effects of fat co-ingestion on postprandial MPS rates? Katsanos et al. found that elevated plasma fatty acid concentrations did not interfere with the post-prandial stimulation of MPS. However, subjects ingested a single bolus of essential amino acids while receiving fatty acid infusion, which clearly does not reflect a 'real world' setting. In the end, there is reason to believe that the presence of fat in a meal further stimulates the muscle anabolic response to meal ingestion. However, fat intake may also modulate gastric emptying and dietary protein digestion and absorption kinetics. To date, the acute (not long-term supplementation) impact of fat in a meal on post-prandial muscle protein anabolism and digestion and absorption kinetics remains completely unexplored, and thus we can only speculate on the impact that fat co-ingestion has on postprandial MPS rates.

In the present study we will investigate the effect of a single meal-like amount of protein with or without fat on postprandial MPS in healthy elderly men. Furthermore, we will assess digestion and absorption kinetics. The use of intrinsically labeled casein will allows us determine de novo MPS from amino acids that come available through the test beverage.

Conditions
Sarcopenia
Being tested
PRO+FAT, PRO
Medical subject headings
Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRO+FATDietary supplement

    Also called 20 g of casein + 26.7 g Anhydrous Milk Fat

  • PRODietary supplement

    Also called 20 g of casein

Study groups in NCT01680146
Study groupRoleWhat they receive
PROActive comparatorSubjects will ingest 20 g of intrinsically labeled casein dissolved in water
Receives: Dietary Supplement: PRO
PRO+FATExperimentalSubjects will ingest 20 g of intrinsically labeled casein plus 26.7 g of anhydrous milk fat dissolved in water
Receives: Dietary Supplement: PRO+FAT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. muscle protein synthesis (MPS) rates

    The main study endpoint is muscle protein synthesis (MPS) rates. In order to determine the MPS, the following parameters will be measured:

    • Muscle protein-bound L-[1-13C]-phenylalanine, L-[ring-2H5]-phenylalanine, and L-[1-13C]-leucine enrichment (expressed as MPE)
    • Plasma L-[1-13C]-phenylalanine and L-[1-13C]-KIC enrichment (expressed as MPE)
    • Muscle free (intracellular) L-[1-13C]-phenylalanine enrichment (expressed as MPE)

    Measured: 1 day

Secondary outcomes (4)
  1. protein digestion and absorption kinetics

    Secondary endpoints include protein digestion and absorption kinetics. Therefore, the following parameters will be measured:

    • Plasma phenylalanine, tyrosine, and leucine concentration (expressed as μmol/L)
    • Plasma enrichments of:
    • L-[1-13C]-phenylalanine
    • L-[1-13C]-tyrosine
    • L-[1-13C]-leucine
    • L-[ring-2H5]-phenylalanine
    • L-[ring-2H4]-tyrosine
    • L-[ring-2H2]-tyrosine

    Measured: 1 day

  2. whole-body protein metabolism

    Secondary endpoints include whole-body protein metabolism, which will be calculated based on protein digestion and absorption kinetics.

    Measured: 1 day

  3. Glucose concentrations

    During the experimental trial, we will measure glucose concentrations in the obtained plasma samples.

    Measured: 1 day

  4. Insulin concentrations

    During the experimental trial, we will measure insulin concentrations in the obtained plasma samples.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

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
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01680146
Sponsor's protocol ID
METC 12-3-030
Acronym
Pro-Fat
Status last verified
Nov 2014
First submitted
21 Aug 2012
Last updated
2 Dec 2014
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
  • Gorissen SHM, Burd NA, Kramer IF, van Kranenburg J, Gijsen AP, Rooyackers O, van Loon LJC. Co-ingesting milk fat with micellar casein does not affect postprandial protein handling in healthy older men. Clin Nutr. 2017 Apr;36(2):429-437. doi: 10.1016/j.clnu.2015.12.011. Epub 2015 Dec 24.

    PubMed 26774526

Questions about this trial

What is this clinical trial studying?

A study testing PRO+FAT and PRO in people with Sarcopenia, run by Maastricht University Medical Center 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 3 inclusion and 10 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 2 Dec 2014. 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.

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 synthesis (MPS) rates (time frame: 1 day). 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 NCT01680146, which also lists 2 linked publications.

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 2 Dec 2014.

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