Talking Heart-Supportive Nutrition With Kate Quackenbush
Heart Health
Nutrition Industry Executive (NIE) asked Kate Quackenbush, Communications Director for France-based Gnosis by Lesaffre to expand on the topic of nutritional support for cardiovascular health.
NIE: What is the state of the market for dietary supplement ingredients for cardiovascular health?
Quackenbush: I would reference a recent survey of 3,500 dietary supplement consumers from the Industry Transparency Center: the “ITC Insight – 2022 Supplement Consumer Survey.” The breakdown of supplement consumers included 1,000 from the U.S., 1,000 from China, 500 from the UK, 500 from Germany, and 500 from Italy. Participants identifying as female represented 52 percent of respondents, and men represented 48 percent of respondents. Ages ranged from 18 to 65-plus years.
Key findings from the survey:
• 63 percent reported, “I am proactive about my health and take steps to lower health risks,” while 76 percent said, “I use/have used vitamins, minerals, herbs or other dietary supplements to manage my health.”
• 62 percent reported using vitamin K2 supplements, ranking in the top 10 ingredients.
• The 18-54 age group brackets showed an increase in usage of vitamin K2 compared to those 55-plus.
• “Perceived effectiveness” of K2 was greater in total supplement users surveyed compared to “regular users.” This suggests that future growth is likely as people who do not currently use vitamin K2 regularly have a high perception of it.
• Bone Health and Heart Health ranked as the top reasons for using vitamin K2, especially for regular users. Irregular users noted various reasons, including “bioavailability of other supplements.” We have been touting this for some time, as it is essential to pair Vitamin K2 with D3 and Calcium supplementation. (https://menaq7.com/bettertogether/)
NIE: What specific advancements in cardiovascular health ingredient technology do you find the most interesting, whether in isolation, extraction, formulation, delivery, or some other area?
Quackenbush: We are gratified to see that vitamin K2 has become integral to cardiovascular-support formulations. What is important to consider is that the more complex a formulation becomes, the greater need to insulate vitamin K2 stability, which requires protective technology.
Ensuring the stability of menaquinone ingredients can be as complex as the finished product formulations that brand owners are conceiving – research shows that moisture and mineral salts are critical variables for degradation, driving the need for a protective technology to shelter the menaquinone molecules during shelf life.
Research shows that vitamin K2 can significantly impact the progression and even regression of hardening of the arteries. This is evidenced by the three-year MenaQ7® cardiovascular study and supported by the 1-year MenaQ7 follow-up cardiovascular study.1,2
Gnosis by Lesaffre introduced our Vitamin K2 Matrix technology in December 2021. Vitamin K2 Matrix is the result of a proprietary technology that protects the particles of MK-7 with no coating, additives, or additional ingredients, providing a less cumbersome and more predictable formulation process for complex K2 products. The technology is so groundbreaking that Nutrition Industry Executive recognized it with a First Place NIE Award for the Excipients/Non-Actives/Delivery Systems Category in October 2022.
Further, Gnosis by Lesaffre announced at SupplySide West 2022 that we are now offering our premium, clinically validated MenaQ7 Vitamin K2 as MK-7 protected by this award-winning technology. Applying the Matrix protective technology to MenaQ7 ensures a smoother process for formulators, guaranteeing consumers receive the clinically validated bone and heart benefits they rightfully expect.
NIE: Briefly, what one or two recent studies on cardiovascular health ingredients or formulations are the most compelling, and why?
Quackenbush: Please consider our 2015 and follow-up 2020 studies:
Thrombosis and Haemostasis, 2015: In this double-blind, randomized, placebo-controlled trial, 244 healthy postmenopausal women were given 180 mcg daily of vitamin K2 as MK-7 (as MenaQ7) or a placebo. The study showed not only cessation but remarkable regression in arterial stiffness (i.e., their arteries became more flexible) in the MenaQ7 group.1
Vascular Disease Therapy, 2020: A one-year, large-scale vascular-health study examined the cardiovascular impact of K2 supplementation (180 mcg as MenaQ7 by Gnosis by Lesaffre) in 243 healthy men and women. This study showed a significant improvement in the activation of the vitamin K-dependent protein matrix GLA protein (MGP), the most potent inhibitor of vascular calcification known, and a positive impact on pulse wave velocity, a measurement of vascular elasticity.2
Vitamin K2 as MK-7 is unique because it impacts arterial calcification; no other compound (drug or vitamin) has been shown to do this. That said, our clinical work is so substantial that it has earned the medical community’s attention, which is now in process with its trials that are using MenaQ7 Vitamin K2 as MK-7 as the source material as a possible therapy for patients whose conditions present symptoms of intense calcification. These trials include:
• The VitaK-CAC Trial,3 which is examining the effects of MenaQ7 on coronary artery calcification (CAC). CAC is a precursor to atherosclerosis and a strong predictor of cardiovascular disease (CVD). The researchers hypothesize that treatment with MK7 will slow down or arrest the progression of CAC and that this trial may lead to a treatment option for vascular calcification and subsequent CVD.
• We announced the protocol for the VIKIPEDIA trial in 2021.4 In this new 1.5-year multi-center, placebo-controlled, randomized, open-label intervention clinical trial using MenaQ7 Vitamin K2 as MK-7, researchers will examine the cardiovascular impact in a patient population [Peritoneal Dialysis (PD) patients], and will use the highest dosage of K2 as MK-7 to date: 1 mg daily. According to researchers, “VIKIPEDIA is the first study to assess whether high dosage of Menaquinone-7 could improve arterial stiffness, mortality, cardiovascular disease, 24-hour ambulatory blood pressure and dialysis efficacy in patients with PD.”
All trials are listed on clinicalstudies.gov (some protocols published; see references). The final patients in VitaK-CAC have completed the trial, so now researchers are reading, coding, and analyzing more than 140 coronary scans. We are very excited about the potential of this study and the impact of its results, which we should announce in early 2023.
Seeing the medical community so invested in a vitamin as a potential therapy for patients is exciting and gratifying. This is a testament to our industry’s great work to deliver safe and effective solutions, demonstrated in clinical research.
NIE: As to B vitamins, what is the top branded B vitamin ingredient for cardiovascular health?
Homocysteine (Hcy) is a common amino acid found in the bloodstream and produced as a metabolite of methionine metabolism in the one-carbon cycle. The plasmatic levels of Hcy are predictive of cardiovascular risk and determined by several factors (lifestyle, genetics, and diet). Today, Hcy is recognized as an independent cardiovascular risk factor: when Hcy levels are greater than normal (15 μmol/L), there is a disruption of Hcy metabolism, associated with arterial inflammation and damage, as well as an increased risk of cardiovascular diseases.
Meta-analysis (72 studies) has demonstrated that lowering blood Hcy by 3μmol/L would reduce an individual’s risk of ischemic heart disease by 16 percent, deep vein thrombosis by 25 percent, and stroke by 24 percent.5
Growing scientific evidence confirms folate’s key role in one-carbon metabolism, the essential pathway supporting fetal development during pregnancy. Lesser known is that folate is vital for many functions, including cardiovascular health.
However, when we use the term folate, we are referring to the generic term given to vitamin B9, a water-soluble vitamin recognized as a critical nutrient during pregnancy, consisting of structurally related compounds, including the synthetic folic acid form, food folates, and the biologically active form 5-MethylTetraHydroFolate (5-MTHF). Although, “folate” and “folic acid” are often used interchangeably, causing considerable confusion. The bioavailability and metabolism of folates actually differ due to their respective chemical structures. All folates, natural or synthetic, must be converted to exert their biological activity.
The active 5-MTHF form of folate, which we offer at Gnosis by Lesaffre as Quatrefolic (the glucosamine salt of 5-MTHF), supports the cycle by converting Hcy to methionine. Perturbations of one-carbon metabolism, owing to low levels of 5-MTHF, critically contribute to increasing circulating Hcy levels and a toxic accumulation in the bloodstream.6
Quatrefolic from Gnosis by Lesaffre offers tangible advantages versus folic acid and can promote healthier heart life – better folate blood levels directly translate to lower Hcy levels, especially for people with MTHFR (methylentetrahydrofolate reductase) polymorphism, which is approximately 40 percent of the global population.7 These genetic alterations can lead to an increase in homocysteine blood levels. While folic acid must be first converted into 5-MTHF by a multi-enzymatic steps process, Quatrefolic is the biologically active form of folate that completely bypasses this metabolic route and is immediately available to the body.
One trial demonstrated that 400 mcg of Quatrefolic (plus B6 and B12) lowered Hcy serum levels better than conventional high-dose folic acid supplementation (5 mg/day). Tested on hypertensive subjects at low cardiovascular risk (104 patients with HCys ≥15 µmol/L), the result shows significant HCys reduction compared to baseline from 21.5 µmol/L to 10.0 µmol/L. Moreover, the ideal HCys level was reached in 55.8 percent of cases in the Quatrefolic group, and it was substantially higher than in the control.8
NIE: Regarding omegas, what branded heart-healthy EFA ingredient should be on formulators’ radar?
Quackenbush: Omega-3s—docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA)—are well-recognized as cardio-protective, earning a qualified health claim for reducing the risk of coronary heart disease and for the ability to lower blood pressure in the U.S., and four EFSA claims for cardiovascular health.
While the omega-3 mechanism of action is linked to these crucial outcomes by supporting healthy inflammation, triglycerides, blood pressure, and promotion of arterial health, it is not recognized for impacting vascular calcification, which health experts believe may cause blood vessels to narrow and lead to the development of heart disease. As MenaQ7 Vitamin K2 as MK-7 has been shown to impact vascular calcification,9 it is the perfect complementary nutrient to support optimal heart health.
Again, MenaQ7 Vitamin K2 as MK-7 has been clinically shown to increase arterial flexibility by activating the most potent inhibitor of arterial calcification: Matrix Gla Protein (MGP).10-12 Further, K2 as MK-7 delivers what omega-3s do not, and that is bone support – it promotes the activation of the K-dependent protein Osteocalcin, which helps bind calcium in the healthy bone matrix. MenaQ7 has been clinically shown to deliver this benefit,13 validating a structure-function claim and an EFSA claim for bone health.
Combining these two complementary and synergistic nutrients offers essential support for those seeking to age in a healthy way. By balancing calcium metabolism, Vitamin K2 provides a synergistic role with omega-3, which could result in unsurpassed cardiovascular support that also delivers bone health benefits.
References:
1 Knapen MH, Braam LA, Drummen NE, et al. Menaquinone-7 supplementation improves arterial stiffness in healthy postmenopausal women. A double-blind randomised clinical trial. Thromb Haemost. 2015;113(5):1135-1144.
2 Vermeer C and Vik H. Effect of Menaquinone-7 (vitamin K2) on vascular elasticity in healthy subjects: Results from a one-year study. Vascul Dis Ther. 2020;5:1–4.
3 Vossen LM, Schurgers LJ, van Varik BJ, et al. Menaquinone-7 supplementation to reduce vascular calcification in patients with coronary artery disease: Rationale and study protocol (VitaK-CAC Trial). Nutrients. 2015;7(11):8905–8915. Published 2015 Oct 28.
4 The Effect of Vitamin K2 Supplementation on Arterial Stiffness and Cardiovascular Events in PEritonial DIAlysis (VIKIPEDIA) https://clinicaltrials.gov/ct2/show/NCT04900610?term=peritoneal&cond=vitamin+k&draw=2&rank=1.
5 Wald DS, Law M, Morris JK. Homocysteine and cardiovascular disease: evidence on causality from a meta-analysis. BMJ. 2002;325(7374):1202.
6 Tinelli C, Di Pino A, Ficulle E, et al. Hyperhomocysteinemia as a risk factor and potential nutraceutical target for certain pathologies. Front Nutr. 2019;6:49. Published 2019 Apr 24.
7 Wilcken B, Bamforth F, Li Z, et al. Geographical and ethnic variation of the 677C>T allele of 5,10 methylenetetrahydrofolate reductase (MTHFR): findings from over 7000 newborns from 16 areas world wide [published correction appears in J Med Genet. 2004 May;41(5):400. Redlund, M [corrected to Renlund, M]]. J Med Genet. 2003;40(8):619–625.
8 Mazza A, Cicero AF, Ramazzina E, et al. Nutraceutical approaches to homocysteine lowering in hypertensive subjects at low cardiovascular risk: a multicenter, randomized clinical trial. J Biol Regul Homeost Agents. 2016;30(3):921–927.
9 Napen MH, Braam LA, Drummen NE, et al. Menaquinone-7 supplementation improves arterial stiffness in healthy postmenopausal women. A double-blind randomised clinical trial. Thromb Haemost. 2015;113(5):1135–1144.
10 Cranenburg EC, Schurgers LJ, Vermeer C. Vitamin K: The coagulation vitamin that became omnipotent. Thromb Haemost. 2007;98(1):120–125. [11] Cranenburg EC, Vermeer C, Koos R, et al. The circulating inactive form of matrix Gla Protein (ucMGP) as a biomarker for cardiovascular calcification. J Vasc Res. 2008;45(5):427-436.
12 Schurgers LJ, Cranenburg EC, Vermeer C. Matrix Gla-protein: The calcification inhibitor in need of vitamin K. Thromb Haemost. 2008;100(4):593–603.
13 Knapen MH, Drummen NE, Smit E, et al. Three-year low-dose menaquinone-7 supplementation helps decrease bone loss in healthy postmenopausal women. Osteoporos Int. 2013;24(9):2499–2507.
