Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000185864
Ethics application status
Approved
Date submitted
22/11/2019
Date registered
22/02/2021
Date last updated
22/02/2021
Date data sharing statement initially provided
22/02/2021
Date results provided
22/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Health benefits of Vitamin C supplementation during health training on physical fitness, body composition and genes expression in elderly women
Scientific title
The influence of health training on physical fitness and the expression of genes encoding selected proteins associated with the iron metabolism
Secondary ID [1] 298283 0
None
Universal Trial Number (UTN)
U1111-1234-1307
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
oxidative stress 312973 0
avitaminose 312974 0
iron metabolism 315298 0
Condition category
Condition code
Metabolic and Endocrine 311481 311481 0 0
Normal metabolism and endocrine development and function
Blood 314314 314314 0 0
Normal development and function of platelets and erythrocytes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study the effect of health training (2x 6-week periods, three times per week for 60 minutes in duration) and suplementation vitamin C in dose 1000 mg/day will be investigation. Vitamin C will be administered in tablets. All participant will keep a supplementation diary. Physical effort and antioxidant supplementation may influence on training adaptation. Vitamin C is well known as antioxidative Vitamin and through reduction in oxidative stress can influence on genes expression, especially easy induce by exercise.
Our study will be involve 15 elderly women (a mean age of 69.2 ± 6.5 years ) randomly chosen to a cross-over study. Women will be randomly divide into two groups. At first 6-week period of health training 7 of them will be supplemented Vit. C while 8 of them will receive a placebo (fiber tablets). In the second 6 week 8 of them (earlier received placebo) will be supplemented and trained while 7 of them will receive fiber in tabs. The wash out period (the break in sessions will last a week). Each volunteer will be qualified by a physician before participation in the study.
The health training will be supervised by the members of our research team. consisting of water gymnastics, gyrokinesis, stabilization training, and Nordic walking at moderate intensity. The type of exercise will be planned in advance for the entire period so that the individual classes are equally distributed. The trainer will additionally record the implementation of the training plan. The training will be conducted for all participants simultaneously, in one group of 15 people. During training, participants maintained their heart rate (Polar H1) at less than 130/min. During whole experiment participants will sign session attendance checklists. All of the tests will be performer in Medical University in Gdansk (genes expression analysis) and University of Physical Education in Kraków (biochemical analysis and level of Vitamin C in serum).
Before and after the first and last interventions period (first and second 6 weeks intervention) measurements of anthropometric indices, body composition are performed. Venous blood is collected from the volunteers four Times: before the start of the experiment, after 6 weeks, before start second 6 week period and at the end of experiment. Vitamin C analysis will be performer immediately after collection, for biochemical analysis serum or plasma will be separate and stored in -80oC, for genetic research lysed leukocytes will be stored in -20oC for further analysis.

Intervention code [1] 316149 0
Prevention
Intervention code [2] 316693 0
Diagnosis / Prognosis
Comparator / control treatment
A group receiving fiber supplementation in a dose: one 5mg tablet consumed orally once daily for 6 weeks
Control group
Active

Outcomes
Primary outcome [1] 322046 0
The effect of health training and health training supported with Vitamin C supplementation on VO2 max..
Will be assessed using the cycloergometer Ergoline Ergoselect 150p (Jaeger OxyconPro) and a gas analyzer (Jaeger OxyconPro).
Timepoint [1] 322046 0
before and 24 h after first 6 week of intervention, before and 24 h after second 6 weeks intervention.
Primary outcome [2] 322047 0
The effect of health training on pro-oxidative and anti-oxidative status
The effect of health training supported with Vitamin C supplementation on Ton pro-oxidative and anti-oxidative status. Composite outcome.
Will be assessed using ELISA KIT (PerOx assay kit Immundiagnostik AG, Germany and ImAnOx assay kit (Immundiagnostik AG, Germany). All analysis will be performed in serum.
Timepoint [2] 322047 0
Before and 24 h after first six week of intervention, before and 24 h after second 6 week of intervention
Primary outcome [3] 322048 0
Influence of health training supported by supplementation on FTH mRNA.
FTH mRNA assessed using qRT-PCR. RNA will be isolate from peripheral blood leukocytes
Timepoint [3] 322048 0
One hour before and 24 h after first six weeks intervention and one hour before and 24 h after second six weeks intervention.
Secondary outcome [1] 377141 0
Analysis of meal size estimated using the Album of Photograph Dishes and Products (Jarosz, 2017),
Timepoint [1] 377141 0
24 h after first 6 week intervention
24 h after second 6 week intervention
Secondary outcome [2] 377142 0
Determination of level of Vitamin C in serum. Will be assessed using the method of Fowler et al. (2014).
Timepoint [2] 377142 0
One hour before and 24 h after first six weeks intervention and one hour before and 24 h after second six weeks intervention.
Secondary outcome [3] 380425 0
Influence on health training supported by supplementation on CAT mRNA.
CAT mRNA assessed using qRT-PCR. RNA will be isolate from peripheral blood leukocytes,
Timepoint [3] 380425 0
One hour before and 24 h after first six weeks intervention and one hour before and 24 h after second six weeks intervention.
Secondary outcome [4] 381324 0
Analysis of diet in elderly women assessed by questionnaire (the Diet 5.0 software, developed by the Food and Nutrition Institute of the Institute of Nutrition and Food (Warszawa, Poland),
Timepoint [4] 381324 0
24 h after first 6 week intervention
24 h after second 6 week intervention

Eligibility
Key inclusion criteria
no chronic disease and no medication, average physical activity (two time per week for 30 min.), lack of supplementation 6 months before experiment
Minimum age
60 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Lack of consent of a doctor on physical activity, chronic illness, medication and supplements

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Volunteers are randomly assigned to the groups.
numbered containers
allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using procedures like coin-tossing and dice-rolling
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
During first 6 weeks of training 7 women will be supplemented and 8 unsupplemented. During second 6 weeks of training 8 women will be supplemented and 7 unsupplemented. For all results, the presence of a normal distribution will be check with the Shapiro-Wilk’s test. Results before and after each six week training period will be compared with parametric or non-parametric (Wilcoxon) tests.. To evaluate within-person changes, the paired t-test and ANOVA one-way test will be applied. The genetic data relative gene expressions were analyzed using the comparative method of Schmittgen and Livak [2008]. TAll calculations and graphics will be performe using GraphPad Prism 6.0. Differences were considered statistically significant at a level of p=0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/09/2019
Date of last participant enrolment
Anticipated
Actual
26/06/2020
Date of last data collection
Anticipated
Actual
30/09/2020
Sample size
Target
15
Accrual to date
Final
15
Recruitment outside Australia
Country [1] 22137 0
Poland
State/province [1] 22137 0
Pomeranian

Funding & Sponsors
Funding source category [1] 302825 0
Government body
Name [1] 302825 0
Polish Ministry of Science and Higher Education No. NRSA 406754 and 169/BS/KK/2018.
Country [1] 302825 0
Poland
Primary sponsor type
University
Name
University of Physical Education in Krakow
Address
al. Jana Pawla II 78
31-571 Krakow
Country
Poland
Secondary sponsor category [1] 304590 0
University
Name [1] 304590 0
Kazimierz Wielki University in Bydgoszcz
Address [1] 304590 0
ul. Jana Karola Chodkiewicza 30
85-064 Bydgoszcz
Country [1] 304590 0
Poland
Other collaborator category [1] 281056 0
University
Name [1] 281056 0
Kazimierz Wielki University in Bydgoszcz
Address [1] 281056 0
ul. Jana Karola Chodkiewicza 30
85-064 Bydgoszcz
Country [1] 281056 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303407 0
Bioethics Committee for Clinical Research at the Regional Medical Chamber in Gdansk
Ethics committee address [1] 303407 0
Ethics committee country [1] 303407 0
Poland
Date submitted for ethics approval [1] 303407 0
Approval date [1] 303407 0
22/11/2016
Ethics approval number [1] 303407 0
KB-10/16

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93570 0
Prof Malgorzata Zychowska
Address 93570 0
Kazimierz Wielki University in Bydgoszcz
ul. Sportowa 2
85-091 Bydgoszcz
Country 93570 0
Poland
Phone 93570 0
+48 881555337
Fax 93570 0
Email 93570 0
malgorzata.zychowska@ukw.edu.pl
Contact person for public queries
Name 93571 0
Malgorzata Zychowska
Address 93571 0
Kazimierz Wielki University in Bydgoszcz
ul. Sportowa 2
85-091 Bydgoszcz
Country 93571 0
Poland
Phone 93571 0
+48 881555337
Fax 93571 0
Email 93571 0
malgorzata.zychowska@ukw.edu.pl
Contact person for scientific queries
Name 93572 0
Malgorzata Zychowska
Address 93572 0
Kazimierz Wielki University in Bydgoszcz
ul. Sportowa 2
85-091 Bydgoszcz
Country 93572 0
Poland
Phone 93572 0
+48 881555337
Fax 93572 0
Email 93572 0
malgorzata.zychowska@ukw.edu.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.