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Not yet recruitingNCT07903480Updated Oct 29, 2026

A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being

An interventional study of Primal Meno+ Supplement in Menopause, Menopausal Symptoms and Hot Flashes, sponsored by Primal Harvest, LLC. Not yet recruiting at 1 site in United States. Open to female participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Primal Harvest, LLC · Not applicable, Interventional, and Treatment

Updated Oct 29, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
40 Years to 60 Years
Sex
Female
01

Study summary

This study evaluates the effects of Primal Harvest's Primal Meno+ supplement on symptoms of menopause and overall well-being in females aged 40-60 who are currently menopausal and experiencing at least two menopausal symptoms. Over a 12-week period, 40 participants will take one capsule of the test product daily with their first meal of the day.

Participants will complete self-reported questionnaires at Baseline, Week 4, Week 8, and Week 12 to assess menopausal symptoms (including hot flashes, night sweats, sleep quality, stress resilience, and emotional well-being) and overall health and well-being. This is a single-arm, open-label, virtual trial with no randomization or blinding.

02

Conditions studied

  • Menopause
  • Menopausal Symptoms
  • Hot Flashes
  • Night Sweats
  • Sleep Disturbance
  • Mood Changes
  • Fatigue
03

In context

Hot Flashes

339 studies on the registry are indexed under Hot Flashes; 56 are open to participants now.

This study's planned enrollment of 40 is below the median of 90 across 306 interventional studies indexed under Hot Flashes.

Browse Hot Flashes studies →

Lead sponsor

This is the only study on the registry with Primal Harvest, LLC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Be female.
  • Be aged 40-60.
  • Anyone who is currently menopausal and experiencing at least two of the following symptoms of menopause: hot flashes
  • night sweats
  • sleep disturbances (e.g., insomnia, trouble falling asleep, staying asleep, or experiencing restless or disrupted sleep)
  • mood changes (e.g., mood swings, irritability, increased anxiety, feelings of sadness or depression)
  • fatigue and lack of energy.
  • Anyone who is generally healthy - does not live with any uncontrolled chronic disease.
  • If taking oral over-the-counter supplements or herbal remedies targeted at symptoms of menopause, has been consistently taking these for at least 3 months prior to starting the study, and is willing to maintain this routine for the study duration.
  • Not planning on introducing any products or any new forms of prescription medication or supplements that target symptoms of menopause for the study duration.
  • Resides in the United States.
  • Willing to maintain the same diet and exercise regimen consistently throughout the study duration.

Exclusion criteria

Exclusion Criteria:

  • Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
  • Anyone with any allergies or sensitivities to any of the study product ingredients.
  • Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period).
  • Anyone unwilling to follow the study protocol.
  • Anyone who is currently taking or planning to take, during the study period, any hormone replacement therapy (HRT).
  • Anyone with a history of uterine fibroids, endometriosis, polycystic ovarian syndrome, or abnormal pap smears.
  • Anyone who is a heavy drinker (i.e., eight or more alcoholic drinks per week for women).
  • Anyone with a history of substance abuse.
  • Currently partaking in another research study or will be partaking in any other research study at any point during this study's duration.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Primal Meno+ Supplement

    Dietary Supplement: Primal Meno+ Supplement

Interventions

  • Dietary supplementPrimal Meno+ Supplement

    All 40 participants take one capsule of Primal Meno+ daily with their first meal of the day for 12 weeks.

06

What researchers measure

Primary outcomes

  1. Change in Symptoms of Menopause

    Assessed via the Menopausal Rating Scale (MRS) validated self-reported questionnaire

    Time frame: Baseline, Week 4, Week 8, and Week 12

  2. Change in Hot Flashes

    Assessed via self-reported questionnaire

    Time frame: Baseline, Week 4, Week 8, and Week 12

  3. Change in Night Sweats

    Assessed via self-reported questionnaire

    Time frame: Baseline, Week 4, Week 8, and Week 12

  4. Change in Stress Resilience

    Assessed via self-reported questionnaire

    Time frame: Baseline, Week 4, Week 8, and Week 12

  5. Change in Sleep Quality

    Assessed via self-reported questionnaire

    Time frame: Baseline, Week 4, Week 8, and Week 12

  6. Change in Emotional Well-being

    Assessed via self-reported questionnaire

    Time frame: Baseline, Week 4, Week 8, and Week 12

Secondary outcomes

  1. Change in Mood

    Assessed via self-reported questionnaire

    Time frame: Baseline, Week 4, Week 8, and Week 12

  2. Change in Night Sweats

    Assessed via self-reported questionnaire

    Time frame: Baseline, Week 4, Week 8, and Week 12

  3. Change in Stress Resilience

    Assessed via self-reported questionnaire

    Time frame: Baseline, Week 4, Week 8, and Week 12

  4. Change in Fatigue

    Assessed via self-reported questionnaire

    Time frame: Baseline, Week 4, Week 8, and Week 12

  5. Change in Quality of Life

    Assessed via self-reported questionnaire

    Time frame: Baseline, Week 4, Week 8, and Week 12

  6. Change in Hot Flashes

    Assessed via self-reported questionnaire

    Time frame: Baseline, Week 4, Week 8, and Week 12

  7. Change in Sleep Quality

    Assessed via self-reported questionnaire

    Time frame: Baseline, Week 4, Week 8, and Week 12

  8. Change in Emotional Well-being

    Assessed via self-reported questionnaire

    Time frame: Baseline, Week 4, Week 8, and Week 12

  9. Change in Overall Health and Well-being

    Assessed via self-reported questionnaire

    Time frame: Baseline, Week 4, Week 8, and Week 12

07

Study locations

1 site
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07903480
Lead sponsor
Primal Harvest, LLC
Collaborators
Citruslabs
Responsible party
Sponsor
First posted
Oct 29, 2026
Start date
Oct 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Oct 29, 2026

Study contacts

Patrick Renner
Contact
hello@citruslabs.com
42424250284

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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