Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000190808
Ethics application status
Approved
Date submitted
22/01/2021
Date registered
23/02/2021
Date last updated
2/03/2022
Date data sharing statement initially provided
23/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of pine bark extract dietary supplement on physical health outcomes in healthy older adults.
Scientific title
The effect of pine bark extract dietary supplement on fasting plasma malondialdehyde (MDA) concentrations in healthy older adults
Secondary ID [1] 303240 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oxidative stress 320399 0
Inflammation 320400 0
Condition category
Condition code
Alternative and Complementary Medicine 318304 318304 0 0
Other alternative and complementary medicine
Diet and Nutrition 318305 318305 0 0
Other diet and nutrition disorders
Musculoskeletal 318660 318660 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The effects of an oral liquid supplement containing 1350mg pinus massoniana extract each day compared to placebo. This double-blinded, randomised controlled trial is a two-armed parallel placebo-controlled design.

Healthy adult individuals will be randomly assigned to consume one of the following everyday for 12 weeks:
Placebo: 50mL oral liquid supplement containing no Pinus Massoniana
Active: 50mL oral liquid supplement containing 1350mg Pinus Massoniana

*Pinus Massoniana (known as Masson pine or Chinese red pine) will be delivered as the commercially available RecoveR8 liquid supplement which has been approved by the TGA as a 'Single Medicine Product' product type.

Participants will be instructed how to consume the study product at their initial baseline visit to the research clinic. The liquid supplement is to be consumed with a meal, preferably breakfast (as part of their habitual diet).

To assess compliance:
1. Participants will be asked to record their daily consumption of the liquid supplement in a standardised log provided to them.
2. Participants will be asked to return all supplement bottles both empty as well as any bottles containing un-consumed product.
Intervention code [1] 319542 0
Prevention
Comparator / control treatment
Placebo will be equivalent in ingredients and sensory characteristics except without pinus massoniana present (active ingredient) which is replaced by cellulose in the placebo solution.
Both products will be manufactured at Tismor Health & Wellness.
Control group
Placebo

Outcomes
Primary outcome [1] 326287 0
Fasting plasma malondialdehyde (MDA) concentrations
Timepoint [1] 326287 0
At baseline (week zero), week 6 (mid-way) and post-intervention (12 weeks). 12-weeks (post intervention) is considered the primary endpoint of this study.
Secondary outcome [1] 390906 0
Fasting plasma Inflammatory cytokines (IL-6, TNF-a, hsCRP)
Timepoint [1] 390906 0
At baseline (week zero), week 6 (mid-way) and post-intervention (12 weeks)
Secondary outcome [2] 390907 0
Plasma concentrations of Immunoglobulins (Ig's) (IgA, IgM, IgG)
Timepoint [2] 390907 0
At baseline (week zero), week 6 (mid-way) and post-intervention (12 weeks)
Secondary outcome [3] 390908 0
Plasma 8-isoprostane
Timepoint [3] 390908 0
At baseline (week zero), week 6 (mid-way) and post-intervention (12 weeks)
Secondary outcome [4] 390909 0
plasma 8-hydroxyguanosine (8-OHG)
Timepoint [4] 390909 0
At baseline (week zero), week 6 (mid-way) and post-intervention (12 weeks)
Secondary outcome [5] 390910 0
Plasma Myostatin concentrations
Timepoint [5] 390910 0
At baseline (week zero), week 6 (mid-way) and post-intervention (12 weeks)
Secondary outcome [6] 390911 0
Plasma endocan concentrations
Timepoint [6] 390911 0
At baseline (week zero), week 6 (mid-way) and post-intervention (12 weeks)
Secondary outcome [7] 390912 0
plasma glucose concentrations
Timepoint [7] 390912 0
At baseline (week zero), week 6 (mid-way) and post-intervention (12 weeks)
Secondary outcome [8] 390913 0
Full blood count
Timepoint [8] 390913 0
At baseline (week zero), week 6 (mid-way) and post-intervention (12 weeks)
Secondary outcome [9] 390914 0
bone mineral content via dual X-ray absorptiometry.
Timepoint [9] 390914 0
At baseline (week zero), week 6 (mid-way) and post-intervention (12 weeks)
Secondary outcome [10] 390915 0
Blood pressure (systolic and diastolic) by digital blood pressure monitor machine
Timepoint [10] 390915 0
At baseline (week zero), week 6 (mid-way) and post-intervention (12 weeks)
Secondary outcome [11] 390916 0
Physical functioning as defined by handgrip strength and assessed by dynamometer
Timepoint [11] 390916 0
At baseline (week zero), week 6 (mid-way) and post-intervention (12 weeks)
Secondary outcome [12] 392080 0
total body mass via dual X-ray absorptiometry.
Timepoint [12] 392080 0
At baseline (week zero), week 6 (mid-way) and post-intervention (12 weeks)
Secondary outcome [13] 392081 0
body fat mass via dual X-ray absorptiometry.
Timepoint [13] 392081 0
At baseline (week zero), week 6 (mid-way) and post-intervention (12 weeks)
Secondary outcome [14] 392082 0
lean muscle mass via dual X-ray absorptiometry.
Timepoint [14] 392082 0
At baseline (week zero), week 6 (mid-way) and post-intervention (12 weeks)
Secondary outcome [15] 392083 0
physical function as defined by balance and assessed by Berg Balance Scale
Timepoint [15] 392083 0
At baseline (week zero), week 6 (mid-way) and post-intervention (12 weeks)
Secondary outcome [16] 392084 0
Physical function test defined by upper limb strength and assessed by upper limb dynamometer
Timepoint [16] 392084 0
At baseline (week zero), week 6 (mid-way) and post-intervention (12 weeks)
Secondary outcome [17] 392085 0
Physical test defined by Short Physical Performance Battery which assesses Balance in standing (tandem stand tests), gait speed test (4m timed walking track) and timed 5 repeated chair stands.
Timepoint [17] 392085 0
At baseline (week zero), week 6 (mid-way) and post-intervention (12 weeks)
Secondary outcome [18] 392086 0
Physical function defined by Timed Up & Go assessed by time taken to stand and walk 3m and back.
Timepoint [18] 392086 0
At baseline (week zero), week 6 (mid-way) and post-intervention (12 weeks)
Secondary outcome [19] 392087 0
Physical function defined by 30 Second Sit to Stand Test assessed by number of sit-to-stand movements conducted in 30seconds.
Timepoint [19] 392087 0
At baseline (week zero), week 6 (mid-way) and post-intervention (12 weeks)
Secondary outcome [20] 392089 0
Quality of life assessed using the SF-36 online questionnaire (Ortho Toolkit)
Timepoint [20] 392089 0
At baseline (week zero), week 6 (mid-way) and post-intervention (12 weeks)

Eligibility
Key inclusion criteria
• Healthy adults aged 55 to 75 years old without existing chronic diseases
• Gender: both males and females
Minimum age
55 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Diagnosed chronic diseases and/or are being treated for chronic diseases e.g. cardiovascular disease, cancer, type 2 diabetes, chronic kidney disease, liver failure, pancreatitis, inflammatory bowel disease etc
• Currently taking any medication and/or supplements known to have anti-inflammatory, antioxidant, blood pressure-lowering, immunosuppressant or anticoagulant effects
• Recently commenced a dietary intervention in the past 3 months or made significant changes to their dietary patterns, food choices, lifestyle and/or physical activity levels in the past 3 months
• Allergic or intolerant to figs, kiwifruit and papaya
• Pregnant or breast-feeding

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)
Intervention product bottles will colour-coded by different coloured bottle caps and only made known to the Chief investigator, The Lead investigator will be blinded from the colour-code definition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation to treatments will be based on the computer generated block randomization method to ensure gender-balanced groups.
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
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size determination
Based on previous estimates of variance in MDA concentrations in healthy older adults (Mean=3.72, SD ± 0.7) to elicit 80% power at a significance level of 0.05 to detect a 0.65 nmol/mL (~17%) difference between the placebo and active group, a total of 50 participants (n=25 per group) are required. We will recruit N=60 (n=30 per group) in order to account for a 20% dropout rate. Allocation to treatment groups will be based on a computer-generated block randomization method to ensure gender-balanced groups.

Overview of statistical methods
Normality will be tested using Shapiro Wilk’s test and visual plots such as histograms and all data will be expressed as either mean±SEM or median (interquartile range) depending on the distribution of the data. An independent t-test for parametric data and Mann Whitney-U test for non-parametric data will be used for comparison of continuous data such as MDA concentrations, blood parameters, BP, body composition, blood pressure and dietary intake between groups. Paired t-tests or Wilcoxon signed-rank test will be used to compare findings within treatment groups. Chi-square test will be used to compare qualitative data between groups such as gender, demographics and physical status. Multiple linear regression will be used to investigate the effects of potential confounding factors such as age. All statistical analyses will be conducted using STATA and a significance level set at 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/02/2021
Actual
3/03/2021
Date of last participant enrolment
Anticipated
24/09/2021
Actual
3/09/2021
Date of last data collection
Anticipated
22/12/2021
Actual
19/10/2021
Sample size
Target
60
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 32819 0
2308 - Newcastle University

Funding & Sponsors
Funding source category [1] 307650 0
Commercial sector/Industry
Name [1] 307650 0
Tismor Health & Wellness
Country [1] 307650 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University of Newcastle
University Drive, Callaghan 2308 NSW
Country
Australia
Secondary sponsor category [1] 308342 0
None
Name [1] 308342 0
Address [1] 308342 0
Country [1] 308342 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307688 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 307688 0
Ethics committee country [1] 307688 0
Australia
Date submitted for ethics approval [1] 307688 0
21/08/2020
Approval date [1] 307688 0
29/09/2020
Ethics approval number [1] 307688 0
H-2020-0271

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

Contacts
Principal investigator
Name 108146 0
Prof Manohar Garg
Address 108146 0
Nutraceuticals Research Program
305C Medical Science Building
University of Newcastle
University Drive
Callaghan, NSW 2308
Country 108146 0
Australia
Phone 108146 0
+61 2 4921 5647
Fax 108146 0
+61-2-4921 2028
Email 108146 0
[email protected]
Contact person for public queries
Name 108147 0
Manohar Garg
Address 108147 0
Nutraceuticals Research Program
305C Medical Science Building
University of Newcastle
University Drive
Callaghan, NSW 2308
Country 108147 0
Australia
Phone 108147 0
+61 2 4921 5647
Fax 108147 0
+61-2-4921 2028
Email 108147 0
[email protected]
Contact person for scientific queries
Name 108148 0
Manohar Garg
Address 108148 0
Nutraceuticals Research Program
305C Medical Science Building
University of Newcastle
University Drive
Callaghan, NSW 2308
Country 108148 0
Australia
Phone 108148 0
+61 2 4921 5647
Fax 108148 0
+61-2-4921 2028
Email 108148 0
[email protected]

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.