Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000282684
Ethics application status
Approved
Date submitted
15/12/2020
Date registered
15/03/2023
Date last updated
15/03/2023
Date data sharing statement initially provided
15/03/2023
Date results provided
15/03/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of polyphenol supplementation on functional ability, cognitive function and quality of life of aged women
Scientific title
Effect of blackcurrant consumption and exercise training on functional ability, cognitive function and quality of life of women 65 -83 years of age
Secondary ID [1] 300332 0
None
Universal Trial Number (UTN)
U1111-1247-0276
Trial acronym
Polycard
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ageing 315943 0
Condition category
Condition code
Other 314212 314212 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
Thirty healthy older women without documented chronic disease volunteered to participate
and were randomly assigned by simple random allocation (drawing lots) to a Polyphenol group, namely the groups that were supplied with blackcurrant extract (Polyphenol group; 15 women) or to a Placebo group that was provided with a placebo capsule (Placebo group;15).
The participants were provided with either capsulated blackcurrant extract, which contained
400mg of blackcurrant extract (Polyphenol group) twice daily (7 days for the short-term phase and three months for the long-term phase with a washout period of 7 days between the two phases). Therefore, each participant was administered 400 mg (two capsules) of blackcurrant extract daily with oral administration. Capsules were administered in the form of dark-purple gelatin capsules (Jarrow Formulas, Los Angeles, California, U.S.A.), identical in appearance (i.e. size and shape). Participants were requested to return drug capsules to monitor adherence to the intervention. The study participants were asked to increase their habitual levels of physical activity. Specifically, they were provided with a structured exercise regime, which was designed specifically for this study, with a description of graded physical activity tasks and instructions on how to perform the exercises that could help. Specifically, they were instructed to engage in at least 30-minute exercise sessions such as walking or swimming per day for the total duration of the study. The International Physical Activity Questionnaire (IPAQ), a self-reported questionnaire for assessing physical activity levels and the Physical Activity Scale for the Elderly (PASE), examined the habitual levels of physical activity. The study design consisted of two phases, the short-term phase and the long-term phase. Before entering the study, all participants underwent an evaluation of functional capacity, cognitive function, and quality of life. After completing the short-term phase, namely seven days, and the end of the long-term phase, namely three months, all the participants were examined at the same parameters. The two phases were separated by a one-week washout period. The duration of the washout period was selected based on the results of other studies. The acute phase lasted seven days (1 week). The total duration of the study was 7 months (from 1.5.2019 until 29.12.2019)
Intervention code [1] 318349 0
Treatment: Other
Comparator / control treatment
Capsules with cornflour were administered in the form of darkpurple gelatin capsules (Jarrow Formulas, Los Angeles, California, U.S.A.), identical in appearance (i.e. size and shape).
Control group
Placebo

Outcomes
Primary outcome [1] 326015 0
Physical function was assessed with the 6-minute walking test.
Timepoint [1] 326015 0
Six minutes walk test: Baseline, after 7 days and 3 months after commencement of the intervention.
Primary outcome [2] 329344 0
Physical function was assessed with the sit-to-stand test.
Timepoint [2] 329344 0
sit-to-stand test: Baseline, after 7 days and 3 months after commencement of the intervention.
Primary outcome [3] 329345 0
Physical function was assessed with the Berg Balance Scale (BBS).
Timepoint [3] 329345 0
Berg Balance Scale: Baseline, after 7 days and 3 months after commencement of the intervention.
Secondary outcome [1] 413382 0
Habitual physical activity levels were assessed with the International Physical Activity Questionnaire (IPAQ) and the Physical Activity Scale for the Elderly (PASE).
Timepoint [1] 413382 0
IPAQ and PASE: after 7 days and 3 months after commencement of the intervention.
Secondary outcome [2] 413386 0
Quality of life was assessed with the Life Satisfaction Inventory.
Timepoint [2] 413386 0
Life Satisfaction Inventory, Mini-Mental state examination and FACIT: Baseline and after the three months of the intervention.
Secondary outcome [3] 413646 0
Cognitive function was assessed with the Mini-Mental State Examination (MMSE)
Timepoint [3] 413646 0
Mini-Mental State Examination: Baseline and after the three months of the intervention.
Secondary outcome [4] 413649 0
The level of fatigue was assessed with the Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue Scale.
Timepoint [4] 413649 0
Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue Scale: Baseline and after the three months of the intervention.

Eligibility
Key inclusion criteria
The participants had to be in a healthy, stable condition for at least three months before entering the study. The participants were also instructed to remain on a stable diet and habitual physical activity levels during the study. None of the patients had participated in any form of regular exercise during the past year. They were also asked to refrain from any other form of recreational activity during the study period.
Minimum age
65 Years
Maximum age
83 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The following exclusion criteria from the study were employed: known cardiovascular disease, unstable angina, myocardial infarction, uncontrolled hypertension, chronic obstructive pulmonary disease, insulin-­dependent diabetes mellitus and severe neurological or orthopedic problems that would hinder the patient''s participation in the study.

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)
Allocation was concealed by numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A G Power analysis was conducted to calculate the sample size based on the results of other similar studies. Descriptive statistics were used to calculate the means ± standard deviation of each variable. The Kolmogorov-­Smirnov and Shapiro-­Wilk tests were used for data normality. Equality of variances was assessed with Levene’s test. Student''s T-­Test for independent samples was used to evaluate the differences between groups and a Student’s T-Test for paired samples to estimate differences within groups. Pearson’s correlation was used, where appropriate, to examine the relation between variables. The level of statistical significance was set at p < 0.05. Statistical analyses were performed using SPSS 26.0 software (IBM SPSS Statistics).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/05/2019
Date of last participant enrolment
Anticipated
Actual
1/09/2019
Date of last data collection
Anticipated
Actual
20/12/2019
Sample size
Target
40
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 23291 0
Greece
State/province [1] 23291 0
Thessaloniki, North of Greece

Funding & Sponsors
Funding source category [1] 304757 0
Self funded/Unfunded
Name [1] 304757 0
Antonia Kaltsatou
Country [1] 304757 0
Greece
Primary sponsor type
Individual
Name
Eleftherios Dimitros
Address
Aristotle University of Thessaloniki, Thermi, 57001, Greece
Country
Greece
Secondary sponsor category [1] 305071 0
None
Name [1] 305071 0
none
Address [1] 305071 0
none
Country [1] 305071 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305175 0
Ethics Committee, University of Thessaly, Department of Exercise Science
Ethics committee address [1] 305175 0
Ethics committee country [1] 305175 0
Greece
Date submitted for ethics approval [1] 305175 0
03/12/2018
Approval date [1] 305175 0
03/04/2019
Ethics approval number [1] 305175 0
1490

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

Contacts
Principal investigator
Name 99494 0
Dr Antonia Kaltsatou
Address 99494 0
University of Thessaly,
Department of Physical Education and Sport Science,
Karies, 42100, Trikala
Country 99494 0
Greece
Phone 99494 0
+306938767967
Fax 99494 0
Email 99494 0
[email protected]
Contact person for public queries
Name 99495 0
Antonia Kaltsatou
Address 99495 0
University of Thessaly,
Department of Physical Education and Sport Science,
Karies, 42100, Trikala
Country 99495 0
Greece
Phone 99495 0
+306938767967
Fax 99495 0
Email 99495 0
[email protected]
Contact person for scientific queries
Name 99496 0
Antonia Kaltsatou
Address 99496 0
University of Thessaly,
Department of Physical Education and Sport Science,
Karies, 42100, Trikala
Country 99496 0
Greece
Phone 99496 0
+306938767967
Fax 99496 0
Email 99496 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results
When will data be available (start and end dates)?
Immediately following publication, the data will be available for five years after publication.
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator ([email protected])


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.