Premenstrual SyndromeNCT05900024
A Study to Evaluate the Effect of Funk It Cycle Bites on PMS
A study testing Funk It Cycle Bites in people with Premenstrual Syndrome, run by Funk It Wellness at 1 site in United States.
Trial summary
This is a virtual, open-label, single-group study that will last 4 menstrual cycles. All participants will complete a questionnaire at the end of their first period after enrolling (baseline/non-intervention cycle 1), then proceed to take the product daily and complete questionnaires at the end of their next 3 periods… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Funk It Cycle Bites
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female aged 18-40
- Have a regular menstrual cycle (every 21-35 days).
- Suffer from mild to moderate menstrual pain.
- May experience mood swings and/or hormonal acne related to the menstrual cycle.
- Otherwise generally healthy.
- Willing to consume the test product with a ginger flavor.
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- Willing to refrain from taking any other supplements or prescription medications that may target the menstrual cycle or premenstrual syndrome (PMS) symptoms throughout the study period.
- Willing and able to adhere to the study protocol, including taking supplements at the required times and completing questionnaires via the technology portal.
- Able to communicate in English.
- Participants must provide written informed consent (ICF).
Who cannot join
- Any unstable or uncontrolled medical or psychiatric illness.
- Any uncontrolled chronic disease or condition that would prevent full participation in the study protocol.
- A history of polycystic ovary syndrome (PCOS), endometriosis, premenstrual dysphoric disorder (PMDD), or undiagnosed vaginal bleeding.
- Are taking hormonal contraception or exogenous sex hormones (estrogen, testosterone, progesterone), or have taken hormonal contraception or exogenous hormones in the past 6 months.
- Are taking any prescription medication or supplements that target the menstrual cycle or PMS symptoms.
- Are pregnant, breastfeeding, trying to become pregnant, or have been pregnant in the past 12 months.
- Have any known severe allergic reactions, or any allergies of any severity to any of the test product's ingredients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single-Group Study to Evaluate the Effect of Funk It Cycle Bites on PMS
This is a virtual, open-label, single-group study that will last 4 menstrual cycles. All participants will complete a questionnaire at the end of their first period after enrolling (baseline/non-intervention cycle 1), then proceed to take the product daily and complete questionnaires at the end of their next 3 periods (intervention cycles 1, 2, and 3). The study will involve 30 female participants with regular menstrual cycles who experience PMS.
Questionnaires will be used to monitor menstrual pain/cramps, energy levels, mood, and hormonal acne experienced before and during the menstrual cycle. Likert scale responses will be statistically compared from baseline to each check-in. Participant responses on product feedback will be presented as % scores.
- Conditions
- Premenstrual Syndrome
- Being tested
- Funk It Cycle Bites
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Funk It Cycle BitesOther
The intervention product contains: Organic Pumpkin Seed Butter, Prebiotic Agave Inulin, Organic Flax Seed, Organic Oat Flour, Organic Ginger, Quinoa Sprouts, Crispy Red Rice, Organic Cacao Nibs, Sunflower Seed Butter, Organic Reishi Mushroom, Organic Amaranth Seeds, Dates, Organic Button Mushroom, Acai Berry, Amla Fruit, Goji Berry, Pomegranate, Cranberry, Acerola (Cherry Juice), Rosemary Extract, Vitamin E (Mixed Tocopherols), Organic Vanilla Extract, Sea Salt, Cinnamon, Naturally Sourced Potassium Sorbate.
| Study group | Role | What they receive |
|---|---|---|
| Cycle Bites | Experimental | Participants will consume 1 Cycle Bite per day. Receives: Other: Funk It Cycle Bites |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptoms of premenstrual syndrome. [Time Frame: Baseline to Month 4]
Survey-based assessment of symptoms using the Premenstrual Symptoms Screening Tool (PSST). Responses will be gathered using a 4-point Likert scale.
Measured: 4 months
Changes in acne. [Time Frame: Baseline to Month 4]
Survey-based assessment of acne using the Acne Quality of Life (Acne-QOL) scale. Responses will be gathered using a 5-point Likert scale.
Measured: 4 months
Changes in pain levels, including menstrual cramps. [Time Frame: Baseline to Month 4]
Survey-based assessment of acne using the Numerical Pain Rating Scale, a 0-10 point rating scale.
Measured: 4 months
Changes in mood stability. [Time Frame: Baseline to Month 4]
Survey-based assessment using study-specific questionnaires. Responses will be gathered using a 5-point Likert scale.
Measured: 4 months
Changes in energy levels. [Time Frame: Baseline to Month 4]
Survey-based assessment using study-specific questionnaires. Responses will be gathered using a 5-point Likert scale.
Measured: 4 months
Secondary outcomes (1)
Participant enjoyment of the product.
Survey-based assessment using study-specific questionnaires. Responses will be gathered using a 5-point Likert scale.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 May 2023
- Primary completion1 Sep 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Funk It Wellness
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900024
- Sponsor's protocol ID
- FunkItWellness
- Status last verified
- Feb 2024
- First submitted
- 2 Jun 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Group Study to Evaluate the Effect of Funk It Cycle Bites on PMS
- ClinicalTrials.gov ID
- NCT05900024
- Acronym / sponsor ID
- FunkItWellness
- Conditions
- Premenstrual Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Funk It WellnessIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a virtual, open-label, single-group study that will last 4 menstrual cycles. All participants will complete a questionnaire at the end of their first period after enrolling (baseline/non-intervention cycle 1), then proceed to take the product daily and complete questionnaires at the end of their next 3 periods (intervention cycles 1, 2, and 3). The study will involve 30 female participants with regular menstrual cycles who experience PMS.
Questionnaires will be used to monitor menstrual pain/cramps, energy levels, mood, and hormonal acne experienced before and during the menstrual cycle. Likert scale responses will be statistically compared from baseline to each check-in. Participant responses on product feedback will be presented as % scores.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cycle Bites | Experimental | Other: Funk It Cycle BitesParticipants will consume 1 Cycle Bite per day. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Female aged 18-40
- Have a regular menstrual cycle (every 21-35 days).
- Suffer from mild to moderate menstrual pain.
- May experience mood swings and/or hormonal acne related to the menstrual cycle.
- Otherwise generally healthy.
Key exclusion criteria (7 listed)
- Any unstable or uncontrolled medical or psychiatric illness.
- Any uncontrolled chronic disease or condition that would prevent full participation in the study protocol.
- A history of polycystic ovary syndrome (PCOS), endometriosis, premenstrual dysphoric disorder (PMDD), or undiagnosed vaginal bleeding.
- Are taking hormonal contraception or exogenous sex hormones (estrogen, testosterone, progesterone), or have taken hormonal contraception or exogenous hormones in the past 6 months.
- Are taking any prescription medication or supplements that target the menstrual cycle or PMS symptoms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Funk It Cycle BitesThe intervention product contains: Organic Pumpkin Seed Butter, Prebiotic Agave Inulin, Organic Flax Seed, Organic Oat Flour, Organic Ginger, Quinoa Sprouts, Crispy Red Rice, Organic Cacao Nibs, Sunflower Seed Butter, Organic Reishi Mushroom, Organic Amaranth Seeds, Dates, Organic Button Mushroom, Acai Berry, Amla Fruit, Goji Berry, Pomegranate, Cranberry, Acerola (Cherry Juice), Rosemary Extract, Vitamin E (Mixed Tocopherols), Organic Vanilla Extract, Sea Salt, Cinnamon, Naturally Sourced Potassium Sorbate. | Other | Cycle Bites |
Primary outcome
Change in symptoms of premenstrual syndrome. [Time Frame: Baseline to Month 4]
Time frame: 4 months
Survey-based assessment of symptoms using the Premenstrual Symptoms Screening Tool (PSST). Responses will be gathered using a 4-point Likert scale.
Changes in acne. [Time Frame: Baseline to Month 4]
Time frame: 4 months
Survey-based assessment of acne using the Acne Quality of Life (Acne-QOL) scale. Responses will be gathered using a 5-point Likert scale.
Changes in pain levels, including menstrual cramps. [Time Frame: Baseline to Month 4]
Time frame: 4 months
Survey-based assessment of acne using the Numerical Pain Rating Scale, a 0-10 point rating scale.
Changes in mood stability. [Time Frame: Baseline to Month 4]
Time frame: 4 months
Survey-based assessment using study-specific questionnaires. Responses will be gathered using a 5-point Likert scale.
Changes in energy levels. [Time Frame: Baseline to Month 4]
Time frame: 4 months
Survey-based assessment using study-specific questionnaires. Responses will be gathered using a 5-point Likert scale.
1 secondary outcome
Participant enjoyment of the product.
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Funk It Cycle Bites in people with Premenstrual Syndrome, run by Funk It Wellness at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symptoms of premenstrual syndrome. [Time Frame: Baseline to Month 4] (time frame: 4 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.