None listed
Conditions
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).
Interventions
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 is
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.
Sponsors
University of Canberra Research Institute for Sport and Exercise
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
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.
Outcome results
None listed