Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000065695
Ethics application status
Approved
Date submitted
17/12/2013
Date registered
21/01/2014
Date last updated
21/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Adaptation to resistance and endurance training with antioxidant supplementation
Scientific title
Does vitamin C and E supplementation alter cellular and physiological adaptation to endurance training and strength training in healthy, young and elderly participants? A double-blind randomized controlled trial.
Secondary ID [1] 283801 0
None
Universal Trial Number (UTN)
U1111-1151-4959
Trial acronym
SARA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin C and E supplementation in healthy, young (18-45 yr) and elderly (>60 yr) participants 290778 0
Strength training in young and elderly (>60 yr) participants 290851 0
Endurance training in Young (18-45 yr) participants 290852 0
Condition category
Condition code
Diet and Nutrition 291141 291141 0 0
Other diet and nutrition disorders
Other 291142 291142 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Supplements (pills) are administrated orally. All participants take 4 x 250 mg vitamin C and 58,5 mg vitamin E daily for 10-12 weeks. The participants get supplements for 2 weeks at the time, and the participants are to return the empty pill bottles when getting new supplies. The participants confirm consumption of supplements in a diary regularly controlled by the investigators.

The study comprises 3 experiments with similar vitamin/placebo supplementation:
Young participants (18-45 yrs.) train either endurance or strength training; two different experiments. Volunteers are recruited separately to each experiment. The participants are in each experiment allocated, randomly to the receive C and E vitamin or placebo supplements.
The endurance training combined with C and E vitamin/placebo supplementation intervention lasted for 11 weeks. The strength training combined with C and E vitamin/placebo supplementation intervention lasted for 10 weeks.

The third experiment is conducted with elderly volunteers (>60 yrs.), and they trained strength and consumed with C and E vitamin/placebo supplementation for 12 weeks.

Supplements (pills) are administrated orally. The participants get supplements for 2 weeks at the time, and the participants are to return the empty pill bottles when getting new supplies. The participants confirm consumption of supplements in a diary regularly controlled by the investigators.

The training programs:
The endurance training program (only young participants): 3-4 sessions per week (primarily running), divided into high intensity interval sessions (4-6x4-6 minutes; >90% of maximal heart rate (HRmax)) and steady state continuous sessions (30-60 minutes; 70-90% of HRmax). The participants have the opportunity to be supervised (by an exercise physiologist) during training, but can also train unsupervised. Supervised training is organized as small groups (3-5 participants). Introduction sessions in use of heart rate monitor (Polar RS400/800CX) and a scale of perceived exertion (Borgs scale) are given to all participants, so that the training intensity can be controlled.

The strength training program#1: Young participants follow a traditional strength training program with four sessions per week. During the first six weeks the loads are 3 x 9-11 RM, whereas in the four lasts weeks the loads are 3-4 x 6-8 RM. The inter-set rest periods are 1-1.5 min. Exercises for all the major muscle groups are included in a split routine: two upper body and two lower body sessions per week. The exercise sessions last for 40-70 min. The young, strength training experienced participants, have the opportunity to be supervised during training (experienced strength coaches), but can also train unsupervised. Introduction sessions in order to learn the exercises are conducted before the intervention.

The strength training program#2: Elderly participants follow a 3 full-body sessions per week, emphasizing free weight exercises where all the major muscle groups are included. Two of the sessions each week are “moderate” (8-10 rep, with 1 min rest between sets), and one varied between “heavy” (3-5 rep, with 2 min rest between sets) and “light” (13-15 rep, with 45 seconds rest between sets)” every second week. The exercise sessions last for 30-60 min. The elderly participants are supervised during all sessions by experienced strength coaches.
Intervention code [1] 288484 0
Treatment: Other
Comparator / control treatment
The vitamin C and E and placebo pills were produced under Good Manufacturing Practice (GMP) requirements at Petefa AB (Vastra Frolunda, Sweden). Each vitamin pill contained 250 mg of ascorbic acid and 58.5 mg DL-alpha-tocopherol acetate (all-rac-alpha- tocopheryl acetate); in addition to cellulose, di/tri-calsium phosphate and magnesium stearate. Similar appearing placebo pills contained the same ingredients, except the vitamins, were produced by the same manufacturer.

The placebo administration is identical to the C+E vitamin administration. The placebo groups follow the same training programs as the vitamin C and E groups.
Control group
Placebo

Outcomes
Primary outcome [1] 291132 0
For the participants that follow the endurance training program: Maximal oxygen uptake during running (direct measurements of oxygen in the in and out breathe: mixing chamber; Jaeger Oxycon Pro, Hoechberg, Germany; treadmill: Woodway ELG 90/200 Sport, Weil am Rhein, Germany)
Timepoint [1] 291132 0
2-4 days after the 11-weeks intervention period
Primary outcome [2] 291206 0
For the participants that follow the strength training program: Lean mass (measured by DXA; Hologic Discovery, Waltham, MA, USA)
Timepoint [2] 291206 0
2-4 days after the 10-12-weeks intervention periods
Secondary outcome [1] 306096 0
For the participants that follow the endurance training program: Mitochondrial proteins (measured in muscle biopsies by western blotting)

Timepoint [1] 306096 0
2-4 days after the 11-weeks intervention period
Secondary outcome [2] 306230 0
For the participants that follow the strength training program: Maximal strength (1 repetition maximum)
Timepoint [2] 306230 0
2-4 days after the 10-12-weeks intervention periods

Eligibility
Key inclusion criteria
Healthy individuals with no injuries that inhibit them from following the training programs.
Young participants: 18-45 years.
Elderly participants: >60 years.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Musculoskeletal injuries and cardiovascular diseases

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All volunteers undergo a medical screening and pre-tests before randomization.

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)
The volunteers were stratified on gender and the randomization was conducted by applying the Graphpads Random number generator (http://graphpad.com/quickcalcs/randomN1.cfm)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be checked for normalization. A two-tailed, unpaired T-test will be used to test for statistical differences in the changes between vitamin C and E supplementation and placebo. Alternatively the Mann-Whitney test will be applied.

For the endurance experiment: If we expect a standard deviation (SD) of 5% we will have 80% power to detect a true mean group differences of approx. 4% with 25 subjects in each group (alpha: 0.05; two-tailed; StatMate, Graphpad software).

For the strength experiment: With an expected gain of 1.5 kg in lean mass and a standard deviation of 0.7. Sixteen volunteers in each group would give 80% power to detect a difference of approximately 0.7 kg. (alpha: 0.05; two-tailed; StatMate, Graphpad software).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/07/2010
Actual
20/09/2010
Date of last participant enrolment
Anticipated
10/09/2012
Actual
10/09/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment outside Australia
Country [1] 5692 0
Norway
State/province [1] 5692 0
Oslo
Country [2] 5727 0
Norway
State/province [2] 5727 0
Lillehammer
Country [3] 5728 0
Norway
State/province [3] 5728 0
Ostfold
Country [4] 5729 0
Norway
State/province [4] 5729 0
Kristiansand

Funding & Sponsors
Funding source category [1] 288459 0
University
Name [1] 288459 0
Norwegian School of Sport Sciences
Country [1] 288459 0
Norway
Primary sponsor type
University
Name
Norwegian School of Sport Sciences
Address
Norwegian School of Sport Sciences
PB. 4014 Ulleval stadion
0806 Oslo, Norway
Country
Norway
Secondary sponsor category [1] 287162 0
University
Name [1] 287162 0
University of Agder
Address [1] 287162 0
University of Agder
PB: 422, 4604 Kristiansand, Norway
Country [1] 287162 0
Norway

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290328 0
Regional Committees for Medical and Health Research Ethics
Ethics committee address [1] 290328 0
Ethics committee country [1] 290328 0
Norway
Date submitted for ethics approval [1] 290328 0
Approval date [1] 290328 0
15/06/2010
Ethics approval number [1] 290328 0

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

Contacts
Principal investigator
Name 44998 0
Dr Goran Paulsen
Address 44998 0
Norwegian School of Sport Sciences
PB: 4014 Ulleval stadion
0806 Oslo, Norway
Country 44998 0
Norway
Phone 44998 0
+4793429420
Fax 44998 0
Email 44998 0
[email protected]
Contact person for public queries
Name 44999 0
Goran Paulsen
Address 44999 0
Norwegian School of Sport Sciences
PB: 4014 Ulleval stadion
0806 Oslo, Norway
Country 44999 0
Norway
Phone 44999 0
+4793429420
Fax 44999 0
Email 44999 0
[email protected]
Contact person for scientific queries
Name 45000 0
Truls Raastad
Address 45000 0
Norwegian School of Sport Sciences
PB: 4014 Ulleval stadion
0806 Oslo, Norway
Country 45000 0
Norway
Phone 45000 0
+4791368896
Fax 45000 0
Email 45000 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
Dimensions AICan supplementation with vitamin C and E alter physiological adaptations to strength training?2014https://doi.org/10.1186/2052-1847-6-28
Dimensions AIValidation of a Pre-Coded Food Diary Used among 60–80 Year Old Men: Comparison of Self-Reported Energy Intake with Objectively Recorded Energy Expenditure2014https://doi.org/10.1371/journal.pone.0102029
N.B. These documents automatically identified may not have been verified by the study sponsor.