ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Negative menstrual cycle symptoms

Condition category

Condition code

Inflammatory and Immune System

Other inflammatory or immune system disorders

Reproductive Health and Childbirth

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]

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]

Any change in menstrual cycle symptom scores

Timepoint [1]

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]

Inflammatory markers (C-reactive protein)

Timepoint [1]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Canberra Research Institute for Sport and Exercise

Address [1]

University of Canberra Research Institute for Sport and Exercise Building 29, University of Canberra Building 29, 11 Kirinari Street Bruce, ACT 2617

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

University of New South Wales (UNSW)

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Canberra Human Research Ethics Commitee

Ethics committee address [1]

Research Services Office,Room 1D88, Bld1,University of Canberra 11 Kirinari Street Bruce ACT 2617 Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/10/2023

Approval date [1]

19/01/2024

Ethics approval number [1]

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

Miss Sara Chica-Latorre

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

Phone

+61 433940204

Fax

sara.chicalatorre@canberra.edu.au

Contact person for public queries

Name

Sara Chica-Latorre

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

Phone

+61 433940204

Fax

sara.chicalatorre@canberra.edu.au

Contact person for scientific queries

Name

Sara Chica-Latorre

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

Phone

+61 433940204

Fax

sara.chicalatorre@canberra.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
21149	Informed consent form					386939-(Uploaded-18-06-2024-14-56-51)-Consent Form RCT MAY FINAL.pdf
21150	Ethical approval					386939-(Uploaded-19-01-2024-09-39-06)-Study-related document.pdf

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.

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