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The effects of additional protein intake on muscle strength and physical performance in physically active elderly


- candidate number26857
- NTR NumberNTR6488
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-mrt-2017
- Secondary IDsNL60137.072.16–IRBN2016017 IRB Nijmegen
- Public TitleThe effects of additional protein intake on muscle strength and physical performance in physically active elderly
- Scientific TitleThe effects of additional protein intake on muscle strength and physical performance in physically active elderly
- ACRONYM
- hypothesisWe hypothesize that the ingestion of an additional amount of dietary protein (2 x 15g per day) will increase muscle strength and physical performance in physically active elderly (≥ 65 yrs). Moreover, we hypothesize that the ingestion of additional protein in physically active elderly will have a beneficial effect on recovery of muscle and joint characteristics during the Four Days Marches.
- Healt Condition(s) or Problem(s) studiedFragility, Sarcopenia, Muscle mass, Loss of strength
- Inclusion criteria- 65 years or older
- Registered for the Nijmegen Four Days Marches 2017
- Protein intake less than 1.0 g/kg bw/d based on FFQ
- Able to understand and perform the study procedures
- Exclusion criteria- Type I or type II diabetes
- Allergic or sensitive for milk proteins, or lactose intolerant.
- Having diagnosed COPD
- Currently treated for cancer
- Having diagnosed renal insufficiency (eGFR<30 (ml/min*1.73m2))
- Having diagnosed intestinal diseases influencing the uptake of protein (i.e. active inflammatory bowel disease, Crohn’s disease)
- Use of statins
- Involved in a heavy resistance type exercise program within the last 2 yrs
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 13-mrt-2017
- planned closingdate31-dec-2017
- Target number of participants120
- InterventionsProtein supplements will be provided as ready-to-drink products of 250 ml containing 15 gram protein (MPC-80) and will be produced by FrieslandCampina. De placebo supplements will be provided as ready-to-drink products of 250 ml and will be produced by FrieslandCampina. The products will be vanilla flavoured. Caloric content is very similar between the products. The products will be consumed twice a day for 13 weeks.
- Primary outcomeChange in maximal voluntary contraction (3 repeated measures (RM) leg extension strength test) and physical performance (SPPB) will be our primary outcome measures.
- Secondary outcomeSecondary study parameters are changes in:
o Muscle contractile function*
o Handgrip strength and microFET (dynamometer)
o Timed up-and-go (TUG)
o Anthropometrics
o Body composition (DEXA)
*Performed in a subgroup of 60 subjects (30 intervention, 30 placebo)
Other parameters are:
o Physical fitness (Åstrand-Rhyming test)
o Physical activity (SQUASH) and exercise training (diary)
o Daily dietary and protein intake (two 24h-recalls + FFQ)
o Compliance (protein supplementation)
o Blood analyses
o Urine analyses
o Medical history questionnaire
o Questionnaire screening sarcopenia (SARC-F)
o Questionnaire quality of life (EQ5D)
o Questionnaires muscle complaints (Short-Form McGill Pain Questionnaire (SF-MPQ) and Short-Form Brief Pain Inventory (BPI-SF))
- Timepointschange in maximal voluntary contraction: 2 time points
Change in SPPB: 4 time points
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. Dominique ten Haaf
- CONTACT for SCIENTIFIC QUERIES Maria Hopman
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
TKI toeslag AF-16501
- Publications
- Brief summaryRationale: Sarcopenia is defined as the age-related loss of skeletal muscle mass, muscle strength and muscle function. These declines can lead to a decrease in physical performance, decreased independence and enhanced vulnerability, and subsequently increased health care costs. Previous studies have shown beneficial effects of enhanced protein intake in frail elderly but little is known about the effect of enhancing protein intake in currently healthy physically active elderly. It has been shown that physically active elderly have the same age-related declines in muscle strength as their inactive peers, while protein recommendations are often not met in both groups.
Objective: The present study has been designed to investigate the impact of additional protein intake on muscle strength and physical performance in physically active elderly.
Study design: The proposed intervention is a 13-week double-blind randomized placebo-controlled trial with 2 arms. The effects of daily protein supplementation (2x 15g provided at breakfast and after exercise or on days without exercise: at lunch) on muscle strength and physical performance will be investigated.
Study population: The study population includes in total 120 subjects, aged 65 years and above with a protein intake in the lowest quartile and registered to participate in the Nijmegen Four Days Marches 2017.
Intervention (if applicable): The physically active elderly subjects will be randomly assigned to the intervention or control group, receiving either protein supplementation (30 gram per day) or placebo. It will be assured that baseline protein intake, gender and age is similar between the groups. The daily supplementation consists of a protein product (30 grams of protein) or an placebo (consisting of carbohydrates). It will be given in the form of 2 drinks that need to be consumed during breakfast and after exercise (or on days without exercise, during lunch).
Main study parameters/endpoints: The primary outcomes are differences in change in muscle strength and physical performance between the intervention and control group after 12 week intervention. Changes in muscle mass and total body composition, muscle, joint and bone markers and questionnaires changes will also be assessed. Furthermore, during the Four Days Marches we will assess differences between the protein-supplemented group and the placebo group in recovery of physical performance and muscle strength and in biomarkers (inflammation, muscle, joint and bone health).
- Main changes (audit trail)
- RECORD10-mrt-2017 - 13-aug-2017


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