Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000682448
Ethics application status
Approved
Date submitted
4/06/2025
Date registered
27/06/2025
Date last updated
27/06/2025
Date data sharing statement initially provided
27/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Sorbet Containing Australian Native Plant Davidson Plum on muscle recovery in Long-distance Runners
Scientific title
The Effect of Sorbet Containing Australian Native Plant Davidson Plum on Oxidative Stress, Antioxidant Defence and Muscle Recovery in Long-Distance Runners
Secondary ID [1] 314587 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammation 337692 0
Condition category
Condition code
Inflammatory and Immune System 334028 334028 0 0
Normal development and function of the immune system
Musculoskeletal 334052 334052 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is designed as a pilot double blind, randomised, placebo-controlled trial over the period of three weeks including baseline and a follow up at 24-, 48- and 72-hours following exercise protocol. At baseline, prior to the supplementation intervention, participants will complete a treadmill running protocol that includes submaximal and then maximal phases. The protocol consists of a 10-minute self-selected warm-up. The starting speed will be individualised to each participant’s current fitness level (determined by the most recent 5- or 10-km race time), with the speed increasing in four stages by 1 km·h-1. The aim of the submaximal phase of the test is to finish at, or just above, the lactate threshold pace, defined by a blood lactate concentration of ~4 mmol. Following a 5-minute recovery period, the participants complete a maximal incremental test to volitional exhaustion, where treadmill speed is increased by 0.5 km·h-1 every 30 seconds until the speed achieved at the end of the submaximal stage is reached. From this point forward, the treadmill speed remains unchanged, and the gradient increased by 0.5% every 30 seconds until volitional exhaustion.
Participants will consume 170g of Strawberry sorbet containing 10% Davidson plum powder or Strawberry sorbet containing no Davidson plum for 10 days following baseline testing administered by the researcher (Dietitian). On day 7, participants will complete a high intensity running session on a treadmill involving 15-minute running at a speed equating to 60% VO2max, determined during the baseline incremental maximal exercise test, and 15-minute running at a speed equating to 75% of VO2max. The participants will be required to complete up to 8 × 1-minute intervals at a speed equating to 95% VO2 max, with 2 minutes of active recovery between each interval, or until volitional exhaustion

Polyphenol intervention - In total, 170 g of Strawberry sorbet containing 10% Australian Freeze-dried Davidson Plum powder (Superfood Co) will be consumed twice daily (2 x 85g) at the pre-determined times (morning and evening) by participants. This equates to 1.5 scoops of sorbet.
Dietary intake will be assessed using a 3-day food diary (2 weekdays and one weekend day) before consuming the functional food product (sorbet) and again at the end of the study during the last week of intervention.
Intervention code [1] 331212 0
Treatment: Other
Comparator / control treatment
The control group will receive placebo sorbet which will contain no Davidson plum powder. Placebo sorbet will be colour matched to the active sorbet. Participants will be instructed to consume the placebo sorbet in the same manner as in the active group.
Placebo intervention - In total, 170 g of Strawberry sorbet without the Australian freeze-dried Davidson Plum powder will be consumed twice daily 2 x 85g) at the pre-determined times (morning and evening) by participants. This equates to 1.5 scoops of sorbet.
Control group
Placebo

Outcomes
Primary outcome [1] 341697 0
Muscle Damage
Timepoint [1] 341697 0
Pre, immediately post and at 24, 48 and 72h post the high intensity interval running session
Primary outcome [2] 341698 0
Neuromuscular Performance
Timepoint [2] 341698 0
Pre, immediately post and at 24, 48 and 72h post the high intensity interval running session
Primary outcome [3] 341699 0
Creatine kinase
Timepoint [3] 341699 0
Pre, immediately post and at 24, 48 and 72h post the high intensity interval running session
Secondary outcome [1] 448391 0
antioxidant defence capacity
Timepoint [1] 448391 0
Pre, immediately post and at 24, 48 and 72h post the high intensity interval running session
Secondary outcome [2] 448392 0
Dietary intake
Timepoint [2] 448392 0
Administered for completion before consuming the functional food product (sorbet) and again at the end of the study during the last week of intervention
Secondary outcome [3] 448393 0
Body weight
Timepoint [3] 448393 0
Baseline and day 10 of intervention
Secondary outcome [4] 448394 0
Heart Rate Variability (HRV)
Timepoint [4] 448394 0
Baseline, day 7 0f intervention and 24, 48 and 72 hours following exercise protocol
Secondary outcome [5] 448395 0
Resting Blood Pressure
Timepoint [5] 448395 0
Baseline, day 7 0f intervention and 24, 48 and 72 hours following exercise protocol
Secondary outcome [6] 448397 0
Muscle Stiffness
Timepoint [6] 448397 0
Pre, immediately post and at 24, 48 and 72h post the high intensity interval running session
Secondary outcome [7] 448487 0
Body fat %
Timepoint [7] 448487 0
Baseline and day 10 of intervention
Secondary outcome [8] 448488 0
Body mass index
Timepoint [8] 448488 0
Baseline and day 10 of intervention
Secondary outcome [9] 448489 0
Body fat mass
Timepoint [9] 448489 0
Baseline and day 10 of intervention
Secondary outcome [10] 448490 0
Fat free mass
Timepoint [10] 448490 0
Baseline and day 10 of intervention
Secondary outcome [11] 448491 0
Muscle mass
Timepoint [11] 448491 0
Baseline and day 10 of intervention
Secondary outcome [12] 448897 0
Oxidative Stress
Timepoint [12] 448897 0
Pre, immediately post and at 24, 48 and 72h post the high intensity interval running session

Eligibility
Key inclusion criteria
Healthy participants (male and female) aged 18-40 years old. Participants fit in anywhere from Recreationally Active, Trained/Developmental, Highly Trained/National Level, Elite/International Level or World Class and must also be competing at a distance of more than 3km.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded from the study if they have a history of non-communicable diseases such as diabetes (all types), cancer, cardiovascular, thyroid, gastrointestinal, renal or pancreatic disease; infectious diseases; cognitive disorders; smoking (including e-cigarette and vaping); being pregnant or lactating; having anaemia (haemoglobin <13 g/dl); having musculoskeletal injury; Sedentary and not meeting the Australian Physical Activity Guidelines; current consumption of alcohol, antacids; anti-inflammatory; antibiotics; antihypertensive; antidiarrheal or laxative medicines; participants on special diets or dietary restrictions, as well as those who were taking antioxidant supplements, prebiotics, or probiotics before the intervention

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)
The active sorbet and placebo sorbet will be assigned selected numbers using the random number generation function in Microsoft Excel. Eligible volunteers will be then randomly assigned, using the online application Research Randomiser to either the intervention group or the placebo group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated into two groups (“placebo” or “active”) based on gender and age. Sequence generation will be block randomised 1:1 using an online randomizer tool (https://www.randomizer.org/).
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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
27/02/2026
Actual
Date of last data collection
Anticipated
20/03/2026
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 319132 0
University
Name [1] 319132 0
University of Canberra
Country [1] 319132 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
Country
Australia
Secondary sponsor category [1] 321600 0
None
Name [1] 321600 0
Address [1] 321600 0
Country [1] 321600 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317727 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 317727 0
Ethics committee country [1] 317727 0
Australia
Date submitted for ethics approval [1] 317727 0
21/05/2025
Approval date [1] 317727 0
16/06/2025
Ethics approval number [1] 317727 0
14449 The Effect of Sorbet Containing Australian Native Plant Davidson

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

Contacts
Principal investigator
Name 141950 0
Miss Brittany Harriden
Address 141950 0
Faculty of Health, University of Canberra, Building 12, Kirinari St, Bruce ACT, 2617
Country 141950 0
Australia
Phone 141950 0
+61 411523128
Fax 141950 0
Email 141950 0
[email protected]
Contact person for public queries
Name 141951 0
Brittany Harriden
Address 141951 0
Faculty of Health, University of Canberra, Building 12, Kirinari St, Bruce ACT, 2617
Country 141951 0
Australia
Phone 141951 0
+61 411523128
Fax 141951 0
Email 141951 0
[email protected]
Contact person for scientific queries
Name 141952 0
Prof Nenad Naumovski
Address 141952 0
Faculty of Health, University of Canberra, Building 12, Kirinari St, Bruce ACT, 2617
Country 141952 0
Australia
Phone 141952 0
+61452466409
Fax 141952 0
Email 141952 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Participants have not consented to provide IPD



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.