Vitamin D and Resistance Exercise in Elderly (NUTRIAGINGVitD)

Aging Clinical Trial

Official title:

Vitamin D and Resistance Exercise in Elderly

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04341818
• Other study ID #: FA219002_2
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: December 2021

Study information

• Verified date: April 2020
• Source: University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2021
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

Other:
• Strength Training and Vitamin D monthly
For 4 wks 50.000 IU vitamin D is given as a monthly dose together with daily 400mg of calcium. Both as a supplement, followed by a 10 weeks resistance training (progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the vitamin D and calcium intake remain.
• Strength Training and Vitamin D daily
For 4 wks 800 IU vitamin D is given as a daily dose together with daily 400mg of calcium. Both as a supplement, followed by a 10 weeks resistance training (progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the vitamin D and calcium intake remain.
• Strength Training and no Vitamin D
For 4 wks no vitamin D is administered, followed by a 10 weeks resistance training (progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the also no vitamin D is given. Over the whole study period participants get 400 mg calcium/day.

Locations

Country	Name	City	State
Austria	University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in handgrip strength (kg)	Handgrip strength of the right hand will be measured to the nearest kilogram (kg) using a hand Dynamometer. Participants will be encouraged to perform a maximal contraction within approximately 4 to 5 s. After a rest of 60 s, participants will be asked to perform a second trial. The highest score of maximum voluntary contraction will be used for data analyses.	baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Secondary	Change from baseline in chair stand test (repetitions within 30s)	The maximum number of completed cycles of unsupported chair rises (from a seated to a fully erected position (hip and knees straightened)) completed within 30 s is counted automatically (Leonardo Mechanography). Force, acceleration, power, kinetic energy, potential energy, mass, total duration, time per iteration are reported as secondary parameters.	baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Secondary	Change from baseline in muscle mass with BIA (kg)		baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Secondary	Change from baseline in 6min walking test (distance in meter)	Participants are instructed to walk alone as quickly as possible (without running) around a 30 m shuttle course as many times as possible within the time limit of 6 mins.	baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Secondary	Change from baseline in the composition of gut-microbiota	Gene sequencing of the 16S rRNA on the stool samples are performed to identify the microbes down to genus level as well as the microbial diversity and relative abundance.	baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Secondary	Change from baseline in stool short-chain fatty acids (SCFAs)	The stool short-chain fatty acids (SCFAs) will be extracted and quantitatively analysed by gas chromatography.	baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Secondary	Change from baseline in oxidative stress marker such as malondialdehyde	The investigators will consider changes in plasma concentrations of oxidative stress marker such as malondialdehyde.	baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Secondary	Change from baseline in inflammatory marker (i.g. IL-6, TNF-alpha)	The investigators will consider changes in plasma concentrations of Interleukin 1 (IL-1), IL-6, IL-8, IL-10, TNF-alpha	baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Secondary	Change from baseline in the metabolomic response	The metabolomic response (ie all metabolites) to the interventions will be analyzed using both nuclear magnetic resonance (NMR) and mass spectrometry (MS) techniques. Patterns of metabolites will be evaluated with statistical techniques, ie discriminant analysis and principal component analysis.	baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Secondary	Change from baseline in the amino acid pattern	The plasma amino acid pattern will be assessed with HPLC-MS.	baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Secondary	Change from baseline in DNA damage (%DNA in the tail)	DNA damage will be assessed in lymphocytes, whole blood and urine in response to the interventions.	baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Secondary	Change from baseline in chromosomal damage (number of micronuclei/1000 binucleated cells)	Chromosomal damage will be assessed in lymphocytes in response to the interventions.	baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)
Secondary	Change from baseline in RDA and DNA gene expression	RNA and DNA gene expression will be assessed in response to the interventions.	baseline, after dietary intervention (4 weeks) and after dietary intervention and strength training (14 weeks)