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Trial registered on ANZCTR


Registration number
ACTRN12624000029594
Ethics application status
Approved
Date submitted
7/12/2023
Date registered
15/01/2024
Date last updated
30/08/2024
Date data sharing statement initially provided
15/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluate the effectiveness of a chocolate intervention as a strategy for menstrual and hormonal contraceptive cycle symptoms management in sportswomen.
Scientific title
Evaluate the effectiveness of a chocolate intervention as a strategy for menstrual and hormonal contraceptive cycle symptoms management in sportswomen
Secondary ID [1] 311031 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Negative menstrual cycle symptoms 332184 0
Condition category
Condition code
Inflammatory and Immune System 329006 329006 0 0
Other inflammatory or immune system disorders
Reproductive Health and Childbirth 329106 329106 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a feasibility intervention trial covering two menstrual/hormonal contraceptive cycles at a baseline stage and two menstrual/hormonal contraceptive cycles at the intervention stage. For the intervention, eligible participants will be randomly allocated to either of two groups, a low cocoa solids group that will be asked to consume 40 grams of milk chocolate (minimum 30% cocoa solids, four squares each 4.5 cm x 3.5 cm), or a high cocoa solids group that will be asked to consume an isocaloric amount of dark chocolate (minimum 70% cocoa solids, four squares each 4.5 cm x 3.5 cm). All participants will consume their allocated chocolate daily for eight consecutive days. Chocolate consumption will start approximately four days before the expected onset of menstruation, or withdrawal bleed (if on hormonal contraceptive), and will cease four days after the onset of menstruation or withdrawal bleed, for a total of 8-days of chocolate consumption, across two cycles. Regardless of group allocation, all participants will continue with their usual dietary intake. Compliance with the intervention will be assessed through a simple yes/no binary question as to whether the prescribed amount of chocolate was consumed daily. Throughout the intervention, participants will be followed up, monitored, and supported with their dietary intake by an Accredited Practicing Dietitian (SCL), to enhance the likelihood of adherence. Reminders to consume the allocated chocolate and complete the questionnaires and logs will be provided daily during the chocolate consumption periods.
Participants will not be asked to avoid any cocoa-related foods or drinks. Instead, participants will be encouraged to continue with their habitual food and drink intake, which might include cocoa-related items. This will be accounted for using daily food diaries.
Participants will not be crossed over into the other group in their second cycle. Instead, they will stay for two consecutive cycles in their initially allocated group.
Intervention code [1] 327579 0
Treatment: Other
Comparator / control treatment
The control for this study will be a low cocoa solids group that will be asked to consume 40 grams of milk chocolate (minimum 30% cocoa solids, four squares each 4.5 cm x 3.5 cm) daily for 8 consecutive days. This group will be equal in size to that of the test group. Hence, this control group is regarded as a dose comparison.
Compliance with the intervention will be assessed through a simple yes/no binary question as to whether the prescribed amount of chocolate was consumed daily. Throughout the intervention, participants will be followed up, monitored, and supported with their dietary intake by an Accredited Practicing Dietitian (SCL), to enhance the likelihood of adherence. Reminders to consume the allocated chocolate and complete the questionnaires and logs will be provided daily during the chocolate consumption periods.
Control group
Dose comparison

Outcomes
Primary outcome [1] 336801 0
Any change in menstrual cycle symptom scores
Timepoint [1] 336801 0
Baseline stage: parameter measured daily for 8 consecutive days, across two consecutive cycles (first two cycles).; Intervention stage: parameter measured daily for 8 consecutive days during chocolate consumption, across two consecutive cycles. Hence, the primary outcome will be measured at 4 time points.
Secondary outcome [1] 429704 0
Inflammatory markers (C-reactive protein)
Timepoint [1] 429704 0
Baseline: Parameter measured at a singular point (approximately 7 days after a positive ovulation test, and 7 days from the onset of bleeding) across two consecutive cycles before commencing intervention, and at a singular point 1 to 4 days from the onset of menstruation (or withdrawal bleed) across two consecutive cycles; Intervention stage: parameter measured at a singular point 1 to 4 days from the onset of menstruation (or withdrawal bleed) across two consecutive cycles. Hence, the secondary outcome will be measured at 6 time points.

Eligibility
Key inclusion criteria
To be eligible, participants will need to:
• Be 18-40 years of age.
• Report regular menstrual cycles (frequent and between 21 to 35 days long) or have used the same form of hormonal (oral) contraception for at least 6-months and regularly experience withdrawal bleeds.
• Participate in team sports competitions.
• Experience at least one negative menstrual-related symptom for at least the past three menstrual cycles.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be ineligible if:
• Pregnant or lactating.
• Diagnosed with any known major diagnosed menstrual disorder such as endometriosis, polycystic ovarian syndrome (PCOS) and adenomyosis.
• Acutely use anti-inflammatory pharmacological or non-pharmacological therapies (medication/supplements) and is not willing to refrain from using them during the intervention period.
• Intolerant or allergic to chocolate.
• Do not experience menstrual-related symptoms.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/03/2024
Actual
28/03/2024
Date of last participant enrolment
Anticipated
20/09/2024
Actual
Date of last data collection
Anticipated
20/12/2024
Actual
Sample size
Target
30
Accrual to date
22
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 315292 0
University
Name [1] 315292 0
University of Canberra Research Institute for Sport and Exercise
Country [1] 315292 0
Australia
Primary sponsor type
University
Name
University of Canberra Research Institute for Sport and Exercise
Address
University of Canberra Research Institute for Sport and Exercise Building 29, University of Canberra Building 29, 11 Kirinari Street Bruce, ACT 2617
Country
Australia
Secondary sponsor category [1] 317454 0
None
Name [1] 317454 0
Address [1] 317454 0
Country [1] 317454 0
Other collaborator category [1] 283165 0
University
Name [1] 283165 0
University of New South Wales (UNSW)
Address [1] 283165 0
Country [1] 283165 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314216 0
University of Canberra Human Research Ethics Commitee
Ethics committee address [1] 314216 0
Research Services Office,Room 1D88, Bld1,University of Canberra 11 Kirinari Street Bruce ACT 2617 Australia
Ethics committee country [1] 314216 0
Australia
Date submitted for ethics approval [1] 314216 0
09/10/2023
Approval date [1] 314216 0
19/01/2024
Ethics approval number [1] 314216 0
13591

Summary
Brief summary
This study will be a feasibility intervention-based Randomised Controlled Trial (RCT) study in menstruating and hormonal contraceptive user sportswomen who experience cycle-related symptoms. The proposed study will consist of a screening stage, an initial stage, a baseline stage covering two menstrual/hormonal contraceptive cycles, and an intervention stage covering two menstrual/hormonal contraceptive cycles. This study will involve dietary supplementation with chocolate with high or low cocoa solids, questionnaires on menstrual and reproductive health, self-monitoring of cycle-related symptoms, training and nutrition, monitoring of body composition, inflammatory markers and sex hormones, and an interview. The investigators hypothesise that chocolate supplementation will help ameliorate cycle-related symptoms, as reported on the Menstrual Distress Questionnaire, and reduce serum inflammatory markers (C-reactive protein).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130814 0
Miss Sara Chica-Latorre
Address 130814 0
University of Canberra Research Institute for Sport and Exercise Building 29, University of Canberra Building 29, 11 Kirinari Street Bruce, ACT 2617
Country 130814 0
Australia
Phone 130814 0
+61 433940204
Fax 130814 0
Email 130814 0
[email protected]
Contact person for public queries
Name 130815 0
Sara Chica-Latorre
Address 130815 0
University of Canberra Research Institute for Sport and Exercise Building 29, University of Canberra Building 29, 11 Kirinari Street Bruce, ACT 2617
Country 130815 0
Australia
Phone 130815 0
+61 433940204
Fax 130815 0
Email 130815 0
[email protected]
Contact person for scientific queries
Name 130816 0
Sara Chica-Latorre
Address 130816 0
University of Canberra Research Institute for Sport and Exercise Building 29, University of Canberra Building 29, 11 Kirinari Street Bruce, ACT 2617
Country 130816 0
Australia
Phone 130816 0
+61 433940204
Fax 130816 0
Email 130816 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
In this study, keeping participants' privacy and confidentiality is paramount. While individual data will be de-identified, there is a risk of re-identification if the IPD of participants is made available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21149Informed consent form    386939-(Uploaded-18-06-2024-14-56-51)-Consent Form RCT MAY FINAL.pdf
21150Ethical approval    386939-(Uploaded-19-01-2024-09-39-06)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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