Clinical trial NCT06018740: A Study to Examine the Effects of a Daily Supplement on Common Symptoms of Perimenopause and Menopause
Official title: A Single Group Clinical Trial to Examine the Effects of a Daily Supplement on Common Symptoms of Perimenopause and Menopause
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Perimenopause
Lead sponsor: Hologram Sciences
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-08-31
Enrollment: 40
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group clinical trial.
Primary purpose: OTHER

Brief summary: Symptoms of perimenopause and menopause can significantly affect overall quality of life. It is hypothesized that daily supplements can reduce the severity of these symptoms. This 12-week clinical trial will examine the effects of Hologram Sciences' Daily Balance Gummy Supplements on symptoms including hot flashes, night sweats, mood swings, anxiety, fatigue, and brain fog. Participants will take the product daily and complete study-specific questionnaires at Baseline, Week 4, Week 8, and Week 12. Upon conclusion of Week 12, participants will be asked to count how many gummies remain in their jar.


Eligibility criteria: Inclusion Criteria:

Women aged 40-65 years old Must be experiencing at least two symptoms of menopause, such as sleep disturbances, mood changes, fatigue and lack of energy, changes in sexual function, urinary changes, irregular or absent periods, or vaginal changes Must experience hot flashes and/or night sweats at least 5 times per day Can be either natural or surgical menopause (or perimenopause) Willing to adhere to the study protocol for the duration of the study

Willing to consult with their physician prior to starting the trial if taking any of the following medications:

Levothyroxine Liothyronine Calcipotriene (Dovonex) Digoxin (Lanoxin) Diltiazem (Cardizem) Verapamil (Calan, others) Thiazide diuretics Atorvastatin (Lipitor) Warfarin - Might increase the amount of time it takes for blood clotting. Minosalicylic acid (Paser) Colchicine (Colcrys, Mitigare, Gloperba) Metformin (Glumetza, Fortamet, others) Proton pump inhibitors (omeprazole (Prilosec), lansoprazole (Prevacid) or other stomach acid-reducing drugs) Phenytoin (Dilantin) Antihypertensive drugs Phenobarbital (Luminal) Amiodarone (Cordarone) Levodopa

Exclusion Criteria:

Not experiencing hot flashes and/or night sweats at least 5 times per day Has taken herbal supplements or multivitamins within the last 1 month Current use of conventional hormone replacement therapies, or plan to start during the study duration Current use of hormonal birth control, or plan to start during the study duration Known allergies to any product ingredients including the purified isoflavone genistein History of uterine fibroids, endometriosis, polycystic ovarian syndrome, or history of abnormal pap smear Anyone with any known severe allergies requiring the use of an epi-pen Unwilling to adhere to the study protocol Anyone living with uncontrolled or chronic health disorders, including oncological or psychiatric disorders No planned invasive medical procedures for the duration of the study Pregnant or breastfeeding

Primary outcomes:
measure: Changes in score on the Menopause Rating Scale (MRS). [Baseline to Week 12]
timeFrame: 12 weeks
measure: Change in hot flashes. [Baseline to Week 12]
timeFrame: 12 weeks
measure: Change in night sweats. [Baseline to 12 Weeks]
timeFrame: 12 weeks
measure: Change in brain fog. [Baseline to Week 12]
timeFrame: 12 weeks
measure: Change in mood swings. [Baseline to Week 12]
timeFrame: 12 weeks
measure: Change in sleep disturbances. [Baseline to Week 12]
timeFrame: 12 weeks
measure: Change in fatigue. [Baseline to Week 12]
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in participant-reported quality of life. [Baseline to Week 12]
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: