Recently, Patricia Kane of Neurolipid.org and BodyBio.com of New Jersey, USA, sent an email to the medical and scientific communities disparaging and mischaracterizing NTFactor®, a patented product from Nutritional Therapeutics of New York (NTI). This email stated that NTFactor® was used in a research study at East Carolina University in North Carolina authored by Dr Saame Shaikh et al. (Biochemistry 2014; 53(35):5589-5591). Statements made by Patricia Kane, PhD that NTFactor® was used in this in vitro research study are false. NTFactor® was not used. And, what was used differs radically from NTFactor®. In fact, recent correspondence from the senior author, Dr. Tonya Zeczycki, regarding Kane’s assertions, states that “It is unfortunate that our results are not interpreted correctly. My objective was to point out that excess levels of phospholipids may have negative effects…” “We feel that lipid replacement therapy is a viable approach and one of great utility.”
Kane’s email contained many false statements about NTFactor®, which is a safe, effective and unique blend of membrane lipids, derived from fractionated soy lecithins. The fractionated lecithins are the only soy component in NTFactor®, which contains only naturally occurring fatty acids [approximately 58% linoleic acid (18:2), 11% oleic (18:1) and 5% linolenic (18:3) acids] and no soy oil. As reported in peer-reviewed clinical publications, NTFactor® has demonstrated that it dramatically improves and sustains healthy mitochondrial function and reduces fatigue.
Listed below are some of the false statements made by Dr. Kane. They are addressed point-by-point from her email dated Nov. 1, 2015:
- “See article by Shaikh SR et al. attached showing that NTFactor® suppresses mitochondrial function.”
Response: This is a completely false and misleading statement. The study by Shaikh SR al. (Biochemistry 2014; 53:5589-5591) DID NOT use NTFactor® or NT Factor Lipids®. Instead, as she has confirmed, it used combinations of cardiolipin (CL) and dioleoyl-phosphatidylcholine (DOPC) from Avanti Polar Lipids, Inc. In addition, the experiment was performed completely in vitro using extremely high, non-physiological concentrations of phospholipid vesicles that were fused with previously frozen and thawed mitochondria in vitro.
- “This research group used Nicolson’s Lipid Replacement Therapy – NTFactor®-which is dioleoyl-phosphatidylcholine (DOPC) basically PC with oleic acid substituting linoleic acid.”
Response: This is a completely false and misleading statement. The experiment did not use Lipid Replacement Therapy and in particular, did not use NTFactor®. According to the Material and Methods section of the publication cited above, only combinations of cardiolipin and DOPC were used in an in vitro experiment, not using NTFactor®, with isolated, trypsin-treated, previously frozen rat heart tissue mitochondria suspended in a buffered saline solution and treated with 1 mg CL or DOPC vesicles in 2 ml buffer-suspended mitochondria. This is a completely non-physiological experiment that resulted in mitochondrial swelling as the lipid vesicles fused with the mitochondria. On the other hand, orally ingested NT Factor has been shown to enhance mitochondrial function in vivo in clinical trials where patients took oral NTFactor® supplement. Their mitochondrial function was then assessed in whole live, intact blood cells obtained by venous puncture at various times. (For example, Agadjanyan M, Vasilevko V, Ghochikyan A, Berns P, Kesslak P, Settineri RA, Nicolson GL. Nutritional supplement (NTFactor) restores mitochondrial function and reduces moderately severe fatigue in aged subjects. J Chronic Fatigue Syndr 2003; 11(3): 23-36). In this clinical trial, mitochondria were not previously frozen, did not swell, and were not isolated and exposed to a non-physiological environments, or non-physiological concentrations of glycerolphospholipids or cardiolipin. Furthermore, NTFactor Lipids are NOT “dioleoyl-phosphatidylcholine (DOPC) basically PC with oleic acid substituting linoleic acid.” NTFactor® is a complex mixture of various membrane glycerolphospholipids (PC, PE, PI, PS, etc.,) that contain primarily the fatty acid linoleic acid (18:2) (58%) not oleic (18:1) acid.
- “They are using a hybrid of soy oil – high oleic soy oil – to make NTFactor which is also a form of lecithin per concentration (verified by $900 analysis).”
Response: This statement is completely false and misleading. NTFactor® is not made at all from soy oil or high oleic acid soy oil. It is a mixed blend of soy-derived glycerolphospholipids derived from soy lecithins that are high in the fatty acid linoleic acid (18:2), not oleic (18:1) acid. The claim that NTFactor® was verified by a $900 analysis without stating the source and results is very questionable. In fact, the “results’ are contrary to already proven analytical laboratory work performed by third party researchers.
- “Patients in the UK report negative responses following the ingestion of NTFactor® and are told are ‘detoxing’.”
Response: This is a completely unsubstantiated statement. Over 40 million doses of NTFactor® have been given to people, without evidence of negative responses or reactions, including people in the UK. In fact, in multiple clinical trials using Lipid Replacement Therapy with NTFactor® or NTFactor Lipids® there was no evidence at all of any negative reactions by trial participants.
- “The oleic is replacing the linoleic in cardiolipin which is pivotal to the health of the mitochondria. With NTFactor®, this paper explains oral ingestion shuts down mitochondrial function.”
Response: This is a completely false and misleading statement. NTFactor® does not contain cardiolipin, which is not transported when ingested. In contrast to the statement above, oral NTFactor® does not shut down mitochondrial function, and indeed, clinical trials show that oral NTFactor® enhances mitochondrial function. The paper referred to (cited in 1 above) did not use Lipid Replacement Therapy and did not use oral ingestion of NTFactor®. It used an in vitro treatment of previously frozen mitochondria with very high, non-physiological concentrations of cardiolipin and phosphatidylcholine.
NTI has been providing NTFactor® based products to physicians, pharmacists, research facilities, hospitals, health care practitioners and consumers since 1993. We are proud of the many benefits that doctors, patients and consumers have enjoyed, along with the clinical research and safety record that we have achieved.
John Casey, COO
Nutritional Therapeutics, Inc
Garth L. Nicolson, PhD, MD (hon.)
President & Chief Scientific Officer
The Institute for Molecular Medicine
Huntington Beach, CA 92647