Evidence-based decision support

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 C-quality evidence.
weight management protocol table

Ingredients for menopause support

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)

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)


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. 

Support menopause with the evidence-based ingredients in this protocol. 

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. 

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.


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. 

Authors

Christopher Knee, ND, MSc

Medical Education Manager

Dr. Christopher Knee is a naturopathic doctor, clinical researcher, and natural health and wellness expert from Ottawa, Canada. As the research and education manager for Fullscript’s Integrative Medical Advisory team, he oversees research projects and the development of medical education content for practitioners and patients across North America. He completed Bachelor's and Master's degrees from the University of Guelph in human kinetics and human biology and nutritional sciences, respectively, and naturopathic training at the Canadian College of Naturopathic Medicine. He's passionate about evidence-informed practice, patient education, health services research, and natural medicines. He has almost 15 years of academic, industry, and advisory experience, having worked with various organizations, including The Ottawa Hospital, the Ottawa Police Service, the University of Ottawa Heart Institute, the Ontario Association of Naturopathic Doctors, the Canadian College of Naturopathic Medicine, Valeant Pharmaceuticals, Nordion, and Pfizer.

Natacha Montpellier, ND

Medical Science Liaison

Dr. Natacha Montpellier is a registered naturopathic doctor in Ontario, Canada. She currently maintains a private clinical practice focused on hormonal and reproductive health. Dr. Natacha, ND, also serves as a Medical Science Liaison on Fullscript’s Medical Advisory team.

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 
  3. Aydın, H., Deyneli, O., Yavuz, D., Gözü, H., Mutlu, N., Kaygusuz, I., & Akalın, S. (2009). Short-Term oral magnesium supplementation suppresses bone turnover in postmenopausal osteoporotic women. Biological Trace Element Research, 133(2), 136–143. https://doi.org/10.1007/s12011-009-8416-8 
  4. Choudhary, D., Bhattacharyya, S., & Bose, S. (2017a). Efficacy and Safety of Ashwagandha (Withania somnifera (L.) Dunal) Root Extract in Improving Memory and Cognitive Functions. Journal of Dietary Supplements, 14(6), 599–612. https://doi.org/10.1080/19390211.2017.1284970 
  5. Choudhary, D., Bhattacharyya, S., & Bose, S. (2017b). Efficacy and Safety of Ashwagandha (Withania somnifera (L.) Dunal) Root Extract in Improving Memory and Cognitive Functions. Journal of Dietary Supplements, 14(6), 599–612. https://doi.org/10.1080/19390211.2017.1284970 
  6. Cormick, G., Ciapponi, A., Cafferata, M. L., & Belizán, J. M. (2015). Calcium supplementation for prevention of primary hypertension. Cochrane Library. https://doi.org/10.1002/14651858.cd010037.pub2 
  7. Dibaba, D. T., Xun, P., Song, Y., Rosanoff, A., Shechter, M., & He, K. (2017). The effect of magnesium supplementation on blood pressure in individuals with insulin resistance, prediabetes, or noncommunicable chronic diseases: a meta-analysis of randomized controlled trials. American Journal of Clinical Nutrition, 106(3), 921–929. https://doi.org/10.3945/ajcn.117.155291 
  8. Firoz, M., & Graber, M. (2001). Bioavailability of US commercial magnesium preparations. PubMed, 14(4), 257–262. https://pubmed.ncbi.nlm.nih.gov/11794633 
  9. Golzarand, M., Shab-Bidar, S., Koochakpoor, G., J, R. S., & Djafarian, K. (2016). Effect of vitamin D3 supplementation on blood pressure in adults: An updated meta-analysis. Nutrition Metabolism and Cardiovascular Diseases, 26(8), 663–673. https://doi.org/10.1016/j.numecd.2016.04.011 
  10. Gopal, S., Ajgaonkar, A., Kanchi, P., Kaundinya, A., Thakare, V., Chauhan, S., & Langade, D. (2021). Effect of an ashwagandha (Withania Somnifera) root extract on climacteric symptoms in women during perimenopause: A randomized, double‐blind, placebo‐controlled study. Journal of Obstetrics and Gynaecology Research, 47(12), 4414–4425. https://doi.org/10.1111/jog.15030 
  11. Keshavarzi, Z., Janghorban, R., Alipour, S., Tahmasebi, S., & Jokar, A. (2019). The effect of vitamin D and E vaginal suppositories on tamoxifen-induced vaginal atrophy in women with breast cancer. Supportive Care in Cancer, 27(4), 1325–1334. https://doi.org/10.1007/s00520-019-04684-6 
  12. König, D., Oesser, S., Scharla, S., Zdzieblik, D., & Gollhofer, A. (2018). Specific collagen peptides improve bone mineral density and bone markers in postmenopausal Women—A randomized controlled study. Nutrients, 10(1), 97. https://doi.org/10.3390/nu10010097 
  13. Kouguchi, T., Ohmori, T., Shimizu, M., Takahata, Y., Maeyama, Y., Suzuki, T., Morimatsu, F., & Tanabe, S. (2013). Effects of a Chicken Collagen Hydrolysate on the Circulation System in Subjects with Mild Hypertension or High-Normal Blood Pressure. Bioscience Biotechnology and Biochemistry, 77(4), 691–696. https://doi.org/10.1271/bbb.120718 
  14. Li, B., Lv, J., Wang, W., & Zhang, D. (2016). Dietary magnesium and calcium intake and risk of depression in the general population: A meta-analysis. Australian & New Zealand Journal of Psychiatry, 51(3), 219–229. https://doi.org/10.1177/0004867416676895 
  15. Lugo, J. P., Saiyed, Z. M., & Lane, N. E. (2015). Efficacy and tolerability of an undenatured type II collagen supplement in modulating knee osteoarthritis symptoms: a multicenter randomized, double-blind, placebo-controlled study. Nutrition Journal, 15(1). https://doi.org/10.1186/s12937-016-0130-8 
  16. Meissner, H. O., Kapczynski, W., Mscisz, A., & Lutomski, J. (2005). Use of gelatinized maca (lepidium peruvianum) in early postmenopausal women. PubMed, 1(1), 33–45. https://pubmed.ncbi.nlm.nih.gov/23674952 
  17. Meissner, H. O., Mscisz, A., Reich-Bilinska, H., Kapczynski, W., Mrozikiewicz, P., Bobkiewicz-Kozlowska, T., Kedzia, B., Lowicka, A., & Barchia, I. (2006). Hormone-Balancing Effect of Pre-Gelatinized Organic Maca (Lepidium peruvianum Chacon): (II) Physiological and Symptomatic Responses of Early-Postmenopausal Women to Standardized doses of Maca in Double Blind, Randomized, Placebo-Controlled, Multi-Centre Clinical Study. PubMed. https://pubmed.ncbi.nlm.nih.gov/23675005 
  18. Meissner, H. O., Mscisz, A., Reich-Bilinska, H., Mrozikiewicz, P., Bobkiewicz-Kozlowska, T., Kedzia, B., Lowicka, A., & Barchia, I. (2006). Hormone-Balancing Effect of Pre-Gelatinized Organic Maca (Lepidium peruvianum Chacon): (III) Clinical responses of early-postmenopausal women to Maca in double blind, randomized, Placebo-controlled, crossover configuration, outpatient study. PubMed. https://pubmed.ncbi.nlm.nih.gov/23675006 
  19. Meissner, H. O., Reich-Bilinska, H., Mscisz, A., & Kedzia, B. (2006). Therapeutic Effects of Pre-Gelatinized Maca (Lepidium Peruvianum Chacon) used as a Non-Hormonal Alternative to HRT in Perimenopausal Women – Clinical Pilot Study. PubMed. https://pubmed.ncbi.nlm.nih.gov/23674976 
  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 
  21. Proksch, E., Segger, D., Degwert, J., Schunck, M., Zague, V., & Oesser, S. (2013). Oral supplementation of specific collagen peptides has beneficial effects on human skin physiology: a Double-Blind, Placebo-Controlled study. Skin Pharmacology and Physiology, 27(1), 47–55. https://doi.org/10.1159/000351376 
  22. Rad, P., Tadayon, M., Abbaspour, M., Latifi, S. M., Rashidi, I., & Delaviz, H. (2015). The effect of vitamin D on vaginal atrophy in postmenopausal women. PubMed, 20(2), 211–215. https://pubmed.ncbi.nlm.nih.gov/25878698 
  23. Rajizadeh, A., Mozaffari-Khosravi, H., Yassini-Ardakani, M., & Dehghani, A. (2017). Effect of magnesium supplementation on depression status in depressed patients with magnesium deficiency: A randomized, double-blind, placebo-controlled trial. Nutrition, 35, 56–60. https://doi.org/10.1016/j.nut.2016.10.014 
  24. Schauss, A. G., Stenehjem, J., Park, J., Endres, J. R., & Clewell, A. (2012). Effect of the novel low molecular weight hydrolyzed chicken sternal Cartilage Extract, BioCell Collagen, on improving Osteoarthritis-Related symptoms: a randomized, Double-Blind, Placebo-Controlled trial. Journal of Agricultural and Food Chemistry, 60(16), 4096–4101. https://doi.org/10.1021/jf205295u 
  25. Schuette, S. A., Lashner, B. A., & Janghorbani, M. (1994). Bioavailability of Magnesium Diglycinate vs Magnesium Oxide in Patients with Ileal Resection. Journal of Parenteral and Enteral Nutrition, 18(5), 430–435. https://doi.org/10.1177/0148607194018005430 
  26. Szkup, M., Jurczak, A., Brodowska, A., Brodowska, A., Noceń, I., Chlubek, D., Laszczyńska, M., Karakiewicz, B., & Grochans, E. (2016). Erratum to: Analysis of relations between the level of MG, ZN, CA, CU, and FE and depressiveness in postmenopausal women. Biological Trace Element Research, 176(1), 64. https://doi.org/10.1007/s12011-016-0837-6 
  27. Walker, E., Lo, K., & Gopal, P. (2024). Gastrointestinal delivery of bitter hop extract reduces appetite and food cravings in healthy adult women undergoing acute fasting. Obesity Pillars, 11, 100117. https://doi.org/10.1016/j.obpill.2024.100117
  28. Weaver, C. M., Alexander, D. D., Boushey, C. J., Dawson-Hughes, B., Lappe, J. M., LeBoff, M. S., Liu, S., Looker, A. C., Wallace, T. C., & Wang, D. D. (2015). Calcium plus vitamin D supplementation and risk of fractures: an updated meta-analysis from the National Osteoporosis Foundation. Osteoporosis International, 27(1), 367–376. https://doi.org/10.1007/s00198-015-3386-5

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