Hormone DisturbanceNCT05328609
An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Hormonal Imbalance
A study testing Semaine Hormonal Imbalance & The Daily in people with Hormone Disturbance, run by Semaine Health at 1 site in United States.
Trial summary
This is an open-label observational trial to study the effectiveness of a commercial dietary supplement and its effect on common symptoms of normal menstrual discomfort. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hormone Disturbance
- What is being tested?
- Semaine Hormonal Imbalance & The Daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2022to 15 Jun 2022
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Female, aged 18-55 (roughly 75% 18-38 and 25% 45-55)
- Ability to take oral medication and be willing to adhere to the dietary supplement regimen (2 capsules per day)
- Willing to fast overnight (12+ hours) prior to the blood collection, and to perform an at-home fingerprick blood test
- Moderate self-reported discomfort related to perceived hormone imbalance. Participants must answer B or C on at least 3 of the following questions:
Who cannot join
- Current use of medication for high blood pressure or for blood thinning
- Diabetic, or on medication such as Metformin or Acarbose
- Pregnancy, breastfeeding, or attempting to become pregnant during study
- Known allergic reactions to components of the dietary supplement (sunflower oil, passionflower, berberine, or grape seed extract )
- Has exercised 3+ times per week of 30 minutes or more per session on average over the past 6 month
- On a ketogenic or vegan diet for more than the past 30 days
- If hormonal birth control, cannot stop during the duration of the study.
Trial locations and contacts
1 site in 1 country.
About this study
This is an open-label observational trial to study the effectiveness of a commercial dietary supplement and its effect on common symptoms of normal menstrual discomfort.
Read the detailed description
This is an open-label observational trial to study the effectiveness of a commercial dietary supplement and its effect on common symptoms of normal menstrual discomfort.
It is hypothesized that the dietary supplement marketed as The Daily will improve subjective wellbeing in trial participants. It is further hypothesized that the dietary supplement will improve plasma biomarkers that have been previously correlated with insulin resistance.
A total of 45 participants will be recruited for the trial following screening, with the expectation that at least 35 will complete the trial. The trial will be fully remote, and all participants will undergo a menstrual cycle without intervention to establish a baseline, and then will be given the intervention (dietary supplement) for a second menstrual cycle.
- Conditions
- Hormone Disturbance
- Being tested
- Semaine Hormonal Imbalance & The Daily
- Medical subject headings
- Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaine Hormonal Imbalance & The DailyDietary supplement
All participants will undergo a menstrual cycle without intervention to establish a baseline, and then will be given the intervention (dietary supplement) for a second menstrual cycle.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Active comparator | Semaine - The Daily Receives: Dietary Supplement: Semaine Hormonal Imbalance & The Daily |
| Control arm | No intervention | No intervention for the time period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discomfort associated with hormone imbalance
Changes in discomfort associated with the most common symptoms linked with perceived hormone imbalance. This outcome measure utilizes a questionnaire using the Likert scale (1-5) with lower values representing an improvement.
Measured: 60 days
Secondary outcomes (2)
Changes in biomarkers linked to insulin sensitivity
Changes in Hemoglobin A1C between baseline and intervention period.
Measured: 60 days
Changes in biomarkers linked to metabolic regulation
Changes in HOMA-IR values between baseline and intervention period.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start15 Mar 2022
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone DisturbanceStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semaine Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328609
- Sponsor's protocol ID
- 20228Semaine
- Status last verified
- Oct 2022
- First submitted
- 30 Mar 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Hormonal Imbalance
- ClinicalTrials.gov ID
- NCT05328609
- Acronym / sponsor ID
- 20228Semaine
- Conditions
- Hormone Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Semaine HealthIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 14 Apr 2022 (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 an open-label observational trial to study the effectiveness of a commercial dietary supplement and its effect on common symptoms of normal menstrual discomfort.
Detailed description
This is an open-label observational trial to study the effectiveness of a commercial dietary supplement and its effect on common symptoms of normal menstrual discomfort.
It is hypothesized that the dietary supplement marketed as The Daily will improve subjective wellbeing in trial participants. It is further hypothesized that the dietary supplement will improve plasma biomarkers that have been previously correlated with insulin resistance.
A total of 45 participants will be recruited for the trial following screening, with the expectation that at least 35 will complete the trial. The trial will be fully remote, and all participants will undergo a menstrual cycle without intervention to establish a baseline, and then will be given the intervention (dietary supplement) for a second menstrual cycle.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Active comparator | Dietary Supplement: Semaine Hormonal Imbalance & The DailySemaine - The Daily |
| Control arm | No intervention | –No intervention for the time period |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Female, aged 18-55 (roughly 75% 18-38 and 25% 45-55)
- Ability to take oral medication and be willing to adhere to the dietary supplement regimen (2 capsules per day)
- Willing to fast overnight (12+ hours) prior to the blood collection, and to perform an at-home fingerprick blood test
Key exclusion criteria (7 listed)
- Current use of medication for high blood pressure or for blood thinning
- Diabetic, or on medication such as Metformin or Acarbose
- Pregnancy, breastfeeding, or attempting to become pregnant during study
- Known allergic reactions to components of the dietary supplement (sunflower oil, passionflower, berberine, or grape seed extract )
- Has exercised 3+ times per week of 30 minutes or more per session on average over the past 6 month
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 |
|---|---|---|
| Semaine Hormonal Imbalance & The DailyAll participants will undergo a menstrual cycle without intervention to establish a baseline, and then will be given the intervention (dietary supplement) for a second menstrual cycle. | Dietary supplement | Intervention arm |
Primary outcome
Discomfort associated with hormone imbalance
Time frame: 60 days
Changes in discomfort associated with the most common symptoms linked with perceived hormone imbalance. This outcome measure utilizes a questionnaire using the Likert scale (1-5) with lower values representing an improvement.
2 secondary outcomes
Changes in biomarkers linked to insulin sensitivity
Time frame: 60 days
Changes in biomarkers linked to metabolic regulation
Time frame: 60 days
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 26 Oct 2022.
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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 Semaine Hormonal Imbalance & The Daily in people with Hormone Disturbance, run by Semaine Health 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 6 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 26 Oct 2022. 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?
Discomfort associated with hormone imbalance (time frame: 60 days). 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 26 Oct 2022.