Clinical trial NCT04341818: Vitamin D and Resistance Exercise in Elderly (NUTRIAGINGVitD)
Official title: Vitamin D and Resistance Exercise in Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Keywords: aging
vitamin D
resistance training
Lead sponsor: University of Vienna
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized, double-blind, controlled intervention study with parallel groups is to investigate the effect of resistance training (2x/week for 10 weeks) with and without different goals of vitamin D intake on muscle strength, function and mass, oxidative stress parameters and the immune system in community dwelling persons. Participants (n = 100) will be community-dwelling older adults. After a preparticipation screening and a vitamin D blood investigation (vitamin D status below 75 nmol/L) participants will be distributed randomly but stratified by sex, age and initial vitamin D plasma levels to one of the 3 groups (Vitamin D daily + strength training, Vitamin D monthly + strength training, no Vitamin D + strength training).

Study participants are eligible if they are male or female with an age between 65 and 85 years and if their cognitive status as well as their physical fitness level allows to participate at the strength training sessions. Exclusion criteria comprise chronic diseases which contraindicate the training sessions, serious cardiovascular disease, diabetic retinopathy and manifest osteoporosis, a frailty index at or above 3, medication with anticoagulants or cortisone drugs, a regular strength training during the last six months and a vitamin D plasma concentration of 75nmol/L or above.

Primary outcome measure is the change in the handgrip strength. Secondary outcome measures comprise anthropometric data, functional performance tests, immunological and oxidative stress parameters, DNA/Chromosomal damage microbiota, metabolomics and the nutritional status.


Eligibility criteria: Inclusion Criteria:

* Males and females between the age of 65 and 85 years
* Adequate mental condition in order to follow the instructions and to perform the resistance exercise independently (Mini-Mental-State \>23)
* Independently mobile

Exclusion Criteria:

* Chronic diseases, which contraindicate a training participation
* Serious cardiovascular diseases (congestive chronic heart failure, severe or symptomatic aortic stenosis, unstable angina pectoris, untreated arterial hypertension, cardiac arrhythmias)
* Diabetic retinopathy
* Manifest osteoporosis
* Regular use of cortisone-containing drugs
* Regular strength training (\> 1x / week) in the last 6 months before inclusion
* Vitamin D plasma level of 75 nmol/l or above

Primary outcomes:
measure: Change from baseline in handgrip strength (kg)
timeFrame: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Secondary outcomes:
measure: Change from baseline in chair stand test (repetitions within 30s)
timeFrame: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
measure: Change from baseline in muscle mass with BIA (kg)
timeFrame: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
measure: Change from baseline in 6min walking test (distance in meter)
timeFrame: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
measure: Change from baseline in the composition of gut-microbiota
timeFrame: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
measure: Change from baseline in stool short-chain fatty acids (SCFAs)
timeFrame: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
measure: Change from baseline in oxidative stress marker such as malondialdehyde
timeFrame: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
measure: Change from baseline in inflammatory marker (i.g. IL-6, TNF-alpha)
timeFrame: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
measure: Change from baseline in the metabolomic response
timeFrame: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
measure: Change from baseline in the amino acid pattern
timeFrame: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
measure: Change from baseline in DNA damage (%DNA in the tail)
timeFrame: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
measure: Change from baseline in chromosomal damage (number of micronuclei/1000 binucleated cells)
timeFrame: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
measure: Change from baseline in RDA and DNA gene expression
timeFrame: baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: University of Vienna
Study officials:
References: