A Study to Examine the Effects of a Daily Supplement on Common Symptoms of Perimenopause and Menopause

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-14

Study Completion Date

2023-11-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Menopause Perimenopause

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group clinical trial.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Open Label

Study Groups

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Daily Balance Gummy

One Daily Balance Gummy should be taken with the last meal of the day.

Group Type EXPERIMENTAL

Daily Balance Gummy

Intervention Type DIETARY_SUPPLEMENT

Phenology Daily Balance Gummies 30 ct. Yuzu Tangerine Flavor. Product contains Vitamin D2, Vitamin K2, Vitamin B6, Vitamin B12, Biotin, Genistein, Saffron Extract, Organic Tapioca Syrup, Organic Cane Sugar, Water, Pectin, Citric Acid, Natural Flavors.

Interventions

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Daily Balance Gummy

Phenology Daily Balance Gummies 30 ct. Yuzu Tangerine Flavor. Product contains Vitamin D2, Vitamin K2, Vitamin B6, Vitamin B12, Biotin, Genistein, Saffron Extract, Organic Tapioca Syrup, Organic Cane Sugar, Water, Pectin, Citric Acid, Natural Flavors.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes