Protocol development in integrative medicine is not typically a simple process. Individuals require individualized care, and what works for one patient may not work for another.

To establish these protocols, we first developed a Rating Scale that could be used to discern the rigor of evidence supporting a specific nutrient’s therapeutic effect.

The following protocols were developed using only A through D-quality evidence.

Class
Qualifying studies
Minimum requirements
A
Systematic review or meta-analysis of human trials
 
B
RDBPC human trials
2+ studies and/or 1 study with 50 + subjects
C
RDBPC human trials
1 study
D
Non-RDBPC human or In-vivo animal trials
 

This comprehensive protocol embraces a whole-person approach to menopause, addressing a range of symptoms beyond the typical hot flashes. The protocol features targeted ingredients to support various aspects of menopausal health: Amarasate® for weight management, and Maca-GO® for hormonal balance, libido, and hot flashes. Additionally, collagen is included for joint and muscle health, while calcium and vitamin D support bone health. Magnesium aids in sleep, stress reduction, and musculoskeletal well-being. Ashwagandha is included for its benefits in reducing stress, enhancing cognitive function, and balancing hormones. This holistic approach ensures that common but often overlooked symptoms are effectively managed.

While the ingredients in this protocol have demonstrated benefits, research specifically targeting peri and postmenopausal women is still evolving. This protocol is designed with the broader goal of supporting menopausal health, incorporating ingredients that may offer valuable support even as research in this specific population continues to develop.

Specialized ingredients 

Amarasate®

Dosing: 125–250 mg, twice per day (Walker 2024)

  • Significantly reduced hunger (30%) and food cravings (40%) in women during a 24-hour water-only fast; both high-dose (500 mg) and low-dose (250 mg) treatments, administered 16 and 20 hours into the fast, led to a significant reduction in appetite and cravings compared to placebo
  • Decreased post-fast ad libitum energy intake by up to 14.5% in women (Walker 2024)
  • Reduced pre-meal cravings for savory foods and post-meal cravings for sugary foods in women (Walker 2024)
  • Increased preprandial ghrelin and postprandial levels of CCK, GLP-1 (600%), and PYY (400%), while reducing postprandial insulin, glucose-dependent insulinotropic peptide (GIP), and pancreatic polypeptide responses without affecting blood glucose levels; this modulation of hormone levels suggests enhanced satiety signals and improved metabolic control without causing hypoglycemia (Walker 2024)
Amarasate® in the Fullscript catalog

Maca-GO®

Dosing: 1 g twice per day for three months (Meissner 2006 a)

  • Reduced menopausal symptoms by 84% in early postmenopausal women and 74–82% in perimenopausal women (Meissner 2006 a)(Meissner 2006 c)
  • Significantly decreased FSH levels while simultaneously increasing LH, estrogen, and progesterone levels in early postmenopausal women after eight months of supplementation (Meissner 2005)
  • Increased bone density markers in early-postmenopausal women after four months of supplementation (Meissner 2006 b)
  • Increased HDL cholesterol levels, reduced LDL cholesterol levels and triglycerides, and helped maintain a healthy body weight in early postmenopausal women after four months of supplementation (Meissner 2006 b)
  • Significantly reduced hot flashes, night sweats, vaginal dryness, and nervousness, and enhanced libido, mood, energy levels, and concentration in perimenopausal women after four months of supplementation (Meissner 2006 c)
Maca-GO® in the Fullscript catalog

Foundational ingredients 

Ashwagandha (Withania somnifera) 

Dosing: 300 mg of ashwagandha root extract twice per day for a minimum of eight weeks (Choudhary 2017)(Gopal 2021) 

  • Stress: 125 mg of Sensoril® standardized extract once per day for eight weeks decreased stress and anxiety score (62%), serum cortisol (14.5%), systolic blood pressure (SBP) (1.6%), and diastolic blood pressure (DBP) (5.6%). (Auddy 2008)
  • Cognitive function: 600 mg of ashwagandha root extract per day for eight weeks increased immediate and general memory, executive function, attention, and information processing speed. (Choudhary 2017) 
  • Hormonal balance: 300 mg twice per day of ashwagandha root extract positively influenced hormonal parameters, with increased serum estradiol and decreased serum FSH and LH levels. (Gopal 2021) 
  • Vasomotor symptoms: 300 mg twice per day of ashwagandha root extract significantly decreased menopause rating scale scores, reflecting improvements in psychological, somatic-vegetative, and urogenital symptoms. (Gopal 2021) 

Click here to learn more about the clinical applications of ashwagandha. 

Ashwagandha in the Fullscript catalog

Calcium and vitamin D

Dosing: >1,000 mg of calcium per day and >800 IU of vitamin D per day, ongoing

  • Hypertension: >800 IU per day of vitamin D (Golzarand 2016) and >1,000 mg of calcium (Cormick 2015) decreased SBP (~1.5–4 mmHg and 1.14 mmHg, respectively) and DBP (~1.2–2.2 mmHg and 0.71 mmHg, respectively).
  • Osteoporosis and fractures: A meta-analysis including eight randomized controlled trials (RCTs) with 30,970 participants found that calcium and vitamin D supplementation reduced the relative risk of total fracture by 15% and hip fracture by 30% in community-dwelling and institutionalized middle-aged to older adults. (Weaver 2016)
  • Vaginal atrophy: 1,000 IU of vitamin D as a vaginal suppository, every night before bed for eight weeks, to postmenopausal women decreased vaginal pH and genitourinary atrophy symptom scores such as pain, dryness, and paleness and increased Vaginal Maturation Index and the number of superficial cells. (Keshavarzi 2019)(Rad 2015)

To learn more about the clinical applications of calcium, click here. For vitamin D, click here. 

Calcium and vitamin D in the Fullscript catalog

Collagen

Dosing: Variable depending on collagen type, ongoing

  • Hypertension: 2.9 g per day of chicken-derived collagen hydrolysate for 12 weeks may decrease SBP and increase serum nitric oxide (NO). ((Kouguchi 2013)
  • Osteoarthritis: 2 g per day of chicken-derived hydrolyzed collagen type II BioCell® and 40 g per day of chicken-derived cartilage, undenatured type II collagen UC-II® for 70–180 days, respectively, may decrease visual analog scale (VAS) pain, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, and joint stiffness. (Lugo 2016)(Schauss 2012)
  • Osteoporosis: 5 g per day of bioactive collagen peptides, Fortibone®, for 12 months may increase spine and neck bone mineral density. (König 2018)
  • Skin aging: 2.5 g per day of porcine-derived bioactive collagen peptides, Verisol® type I collagen, for four weeks may decrease eye wrinkle volume by 20% and increase procollagen type I and elastin content by 65%. (Proksch 2013a)(Proksch 2013b)

Click here to learn more about the clinical application of collagen.

Collagen in the Fullscript catalog

Magnesium

Dosing: 320 mg to >1 g per day (depending on the form) for a minimum of eight weeks

  • Depression: Postmenopausal women with depressive symptoms exhibit notably lower magnesium levels (14.28 ± 2.13 mg/L) than those without depressive symptoms (16.30 ± 3.51 mg/L). (Szkup 2016) Supplementing with 320–500 mg of magnesium per day for eight weeks may decrease the risk for depression and Beck scores. (Li 2017)(Rajizadeh 2017)
  • Hypertension: 365–450 mg of elemental magnesium for 1–6 months decreased SBP (-4.18 mmHg) and DBP (-2.27 mmHg) in individuals with insulin resistance, prediabetes, or noncommunicable chronic diseases. (Dibaba 2017)
  • Osteoporosis: 1,830 mg of magnesium citrate per day for 30 days in postmenopausal women decreased serum intact parathyroid hormone (iPTH) and urinary deoxypyridinoline and increased serum osteocalcin. (Aydin 2009)
  • Sleep issues: 500 mg of magnesium oxide twice daily for eight weeks increased sleep time, sleep efficiency, and serum melatonin levels and decreased sleep onset latency and serum cortisol levels. (Abbasi 2012) Magnesium glycinate has a greater absorption rate than magnesium oxide and could provide similar benefits at a lower dose with fewer side effects (24% vs. 4%). (Firoz 2001)(Schuette 1994)

Click here to learn more about the clinical application of magnesium. 

Magnesium in the Fullscript catalog

Disclaimer

The Fullscript Integrative Medical Advisory team has developed or collected these protocols from practitioners and supplier partners to help health care practitioners make decisions when building treatment plans. By adding this protocol to your Fullscript template library, you understand and accept that the recommendations in the protocol are for initial guidance and may not be appropriate for every patient.

View protocol on Fullscript
References
  1. Abbasi, B., Kimiagar, M., Sadeghniiat, K., Shirazi, M. M., Hedayati, M., & Rashidkhani, B. (2012). The effect of magnesium supplementation on primary insomnia in elderly: A double-blind placebo-controlled clinical trial. DOAJ (DOAJ: Directory of Open Access Journals). https://doaj.org/article/0948678c0dcd4ff7a9fca8655625591f 
  2. Auddy, B., Hazra, J., Mitra, A., Abedon, B., Ghosal, S., & Nagar, B. (2008). A Standardized Withania Somnifera Extract Significantly Reduces Stress-Related Parameters in Chronically Stressed Humans: A Double-Blind, Randomized, Placebo-Controlled Study. JANA. https://www.researchgate.net/profile/Achintya_Mitra/publication/242151370_A_Standardized_Withania_Somnifera_Extract_Significantly_Reduces_Stress-Related_Parameters_in_Chronically_Stressed_Humans_A_Double-Blind_Randomized_Placebo-Controlled_Study/links/54d6463a0cf2970e4e6a4f3f.pdf 
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  20. Proksch, E., Schunck, M., Zague, V., Segger, D., Degwert, J., & Oesser, S. (2013). Oral intake of specific bioactive collagen peptides reduces skin wrinkles and increases dermal matrix synthesis. Skin Pharmacology and Physiology, 27(3), 113–119. https://doi.org/10.1159/000355523 
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