Metabolic HealthNCT07268404
Women's Hormonal and Metabolic Wellbeing Study
A study testing Probiotic Blend Capsule in people with Metabolic Health, run by Daily Nouri at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if Daily Nouri Hormone Balance Probiotic blend can improve metabolic, inflammatory, and symptom outcomes in women. Participants will: Take the probiotic blend or placebo every day for 12 weeks Complete virtual assessments and report symptoms throughout the study Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Health
- What is being tested?
- Probiotic Blend Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Self-reported irregular menstrual cycles, defined as one or more of the following:
- Cycle length typically >35 days OR <21 days
- Fewer than 9 menstrual periods in the past year
- Unpredictable cycle timing (varies by >7 days month-to-month)
- Irregular cycles present for ≥6 months
- One or more of the following hormonal balance concerns: skin, unwanted hair growth, hair thinning, weight concerns)
Show all 18Show fewer
- Self-reported emotional symptoms that fluctuate with menstrual cycle, including:
- Mood swings or irritability
- Feelings of stress or tension
- Low mood or feeling down
- Difficulty with emotional regulation
- Not currently using hormonal therapies, metformin, GLP-1 receptor agonists, or anti-androgens.
- If taking supplements for menstrual/hormonal support: willing to discontinue for 2-week washout before baseline
- Weight stable (+ 5 pounds) for the past 2 months, not planning to start a new diet, exercise program, or medications during study
- Able to provide electronic informed consent.
- Willing to complete online surveys and at-home DBS sample collection.
- Negative home pregnancy test at baseline.
- Access to a computer or smartphone and reliable internet connection.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Alethios, Inc.
San Francisco, California, 94109
Alethios, (650) 206-8006, support@alethios.com
About this study
Official title: A 12-Week Virtual, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Effects of Daily Nouri Hormone Balance Probiotic on Metabolic, Inflammatory, and Symptom Outcomes in Women
The goal of this clinical trial is to learn if Daily Nouri Hormone Balance Probiotic blend can improve metabolic, inflammatory, and symptom outcomes in women.
Participants will:
- Take the probiotic blend or placebo every day for 12 weeks
- Complete virtual assessments and report symptoms throughout the study
Read the detailed description
This study is a 12-week, prospective, randomized, controlled clinical trial. It is an interventional study with participants assigned to either an active or control group. All study visits will be conducted virtually, including completion of questionnaires, collection of blood samples, and other assessments.
- Conditions
- Metabolic Health
- Being tested
- Probiotic Blend Capsule, Placebo
- Keywords
- dietary supplement, quality of life, women's health, hormone balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Blend CapsuleDietary supplement
Hormone Balance Probiotic Blend
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Dietary Supplement Capsule | Experimental | Hormone Balance Probiotic blend Receives: Dietary Supplement: Probiotic Blend Capsule |
| Placebo: Capsule | Placebo comparator | Identical capsule containing inactive ingredients Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Women's Health Quality of Life Scores
Women's Health Quality of Life as measured by changes in total and domains scores on the Health-Related Quality of Life Questionnaire for Polycystic Ovary Syndrome-26 (PCOSQ-26). Response Scale: 7-Point Likert Scale Per-Item Range: minimum: 1, maximum: 7, where higher scores indicate better outcomes.
Measured: From baseline to week 12
Secondary outcomes (8)
Overall Health Quality of Life Scores
Assessed by monthly Patient-Reported Outcomes Measurement Information System - 29 Profile (PROMIS-29) questionnaire. 28 items use 5-point Likert scale responses (0-4), 1 item is a numeric rating scale (0-10). For negatively-worded concepts higher scores indicate worse outcomes, for positively-worded concepts higher scores indicate better outcomes.
Measured: 12 weeks
Change from baseline to Week 12 in Fasting Blood Glucose
Fasting Blood Glucose will be analyzed from dried blood spots (DBS), reported as mg/dL (milligrams per deciliter).
Measured: 12 weeks
Change from baseline to Week 12 in Glycated Hemoglobin A1c (HbA1c)
HbA1c will be analyzed from dried blood spots (DBS), reported as percentage (%).
Measured: 12 weeks
Change from baseline to Week 12 in High-Sensitivity C-Reactive Protein (hsCRP).
hsCRP will be analyzed from dried blood spots (DBS), reported as mg/L (milligrams per liter).
Measured: 12 weeks
Supplementary Question - Sleep
Over the past 7 days, how would you rate your sleep quality overall? Visual Analog Scale, (0 = very poor, 10 = excellent) Over the past 7 days, how would you rate your energy level? Visual Analog Scale (0 = no energy/extremely fatigued, 10 = full energy/not fatigued at all)
Measured: 12 weeks
Supplementary Question - Acne Severity
How would you rate the severity of your acne over the past 7 days? Visual Analog Scale, (Response: 0-10 scale, where 0 = no acne and 10 = severe acne)
Measured: 12 weeks
Supplementary Question - Acne
To what extent does your acne currently affect your quality of life? (Response: 5-point Likert, from 'not at all' to 'extremely')
Measured: 12 weeks
Supplementary Question - Sexual Health
Over the past 7 days, how would you rate your overall sexual interest and satisfaction? Visual Analog Scale (0 = Very poor, 10 = Excellent)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start10 Dec 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic HealthStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daily Nouri
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268404
- Sponsor's protocol ID
- DNO001_14865
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week Virtual, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Effects of Daily Nouri Hormone Balance Probiotic on Metabolic, Inflammatory, and Symptom Outcomes in Women
- ClinicalTrials.gov ID
- NCT07268404
- Acronym / sponsor ID
- DNO001_14865
- Conditions
- Metabolic Health
- Keywords
- dietary supplement, quality of life, women's health, hormone balance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Daily NouriIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Dec 2025 (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.
The goal of this clinical trial is to learn if Daily Nouri Hormone Balance Probiotic blend can improve metabolic, inflammatory, and symptom outcomes in women.
Participants will:
- Take the probiotic blend or placebo every day for 12 weeks
- Complete virtual assessments and report symptoms throughout the study
Detailed description
This study is a 12-week, prospective, randomized, controlled clinical trial. It is an interventional study with participants assigned to either an active or control group. All study visits will be conducted virtually, including completion of questionnaires, collection of blood samples, and other assessments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Dietary Supplement Capsule | Experimental | Dietary Supplement: Probiotic Blend CapsuleHormone Balance Probiotic blend |
| Placebo: Capsule | Placebo comparator | Dietary Supplement: PlaceboIdentical capsule containing inactive ingredients |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Self-reported irregular menstrual cycles, defined as one or more of the following:
- One or more of the following hormonal balance concerns: skin, unwanted hair growth, hair thinning, weight concerns)
- Self-reported emotional symptoms that fluctuate with menstrual cycle, including:
- Not currently using hormonal therapies, metformin, GLP-1 receptor agonists, or anti-androgens.
- If taking supplements for menstrual/hormonal support: willing to discontinue for 2-week washout before baseline
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Probiotic Blend CapsuleHormone Balance Probiotic Blend | Dietary supplement | Intervention: Dietary Supplement Capsule |
| PlaceboPlacebo | Dietary supplement | Placebo: Capsule |
Primary outcome
Women's Health Quality of Life Scores
Time frame: From baseline to week 12
Women's Health Quality of Life as measured by changes in total and domains scores on the Health-Related Quality of Life Questionnaire for Polycystic Ovary Syndrome-26 (PCOSQ-26). Response Scale: 7-Point Likert Scale Per-Item Range: minimum: 1, maximum: 7, where higher scores indicate better outcomes.
8 secondary outcomes
Overall Health Quality of Life Scores
Time frame: 12 weeks
Change from baseline to Week 12 in Fasting Blood Glucose
Time frame: 12 weeks
Change from baseline to Week 12 in Glycated Hemoglobin A1c (HbA1c)
Time frame: 12 weeks
Change from baseline to Week 12 in High-Sensitivity C-Reactive Protein (hsCRP).
Time frame: 12 weeks
Supplementary Question - Sleep
Time frame: 12 weeks
Supplementary Question - Acne Severity
Time frame: 12 weeks
Supplementary Question - Acne
Time frame: 12 weeks
Supplementary Question - Sexual Health
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Blend Capsule in people with Metabolic Health, run by Daily Nouri 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 18 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 25 Aug 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Women's Health Quality of Life Scores (time frame: From baseline to week 12). 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 25 Aug 2026.