FoalMaker = double-blind + placebo-controlled study published + patent (breeding stallions + semen quality + pregnancies per cycle) for a 62.5% relative increase in per cycle conception rate.
Optimal is to start supplementation 60–90 days pre-breeding. The patent is for improving per-cycle conception rates through nutritional supplementation. Both the stallion and mare products are covered by the patent work.
In other words: there was no statistical change in the non-supplemented control stallions, but those getting FoalMaker created MORE pregnancies, with 128 FEWER cycles!.
We will have a limited supply in this pre-launch year. Depending on the timing of responses, it is likely that shipments will be split so every committed customer can be covered for the entire gestation. In future, the goal is to provide 14 months in a single shipment and payment for each mare in her first year on product, then 12 months for following years.
There is one clearly identifiable published abstract that tests FoalMaker in breeding stallions, earlier reporting on that controlled trial, and a separate body of mechanistic papers. The distinction matters. Many papers cited around glucosamine and glycosaminoglycans support a biological rationale for ingredients. They do not, by themselves, test the finished FoalMaker product.
Nie G., Rohrback B., Wenzel J., Bennett B., Bailey J., Martin J., Davenport D. (2003). “Effect of Feeding a Nutritional Supplement (FoalMaker™) to Breeding Stallions on Semen Quality and Pregnancies per Cycle in a Double Blind, Placebo Controlled Study.” Journal of the American College of Nutrition, 22(5), p. 475, Abstract 79.
It was also presented at the 2003 American Academy of Veterinary Nutrition Clinical Nutrition and Research Symposium at the ACVIM Annual Meeting, and as a poster at the American College of Nutrition 44th Annual Symposium. The title itself identifies the design: double-blind, placebo-controlled, breeding stallions, semen quality, pregnancies per cycle. This is the citation to put first. It is an abstract, not a full peer-reviewed paper.
In January 2002, DVM360 reported midpoint results from the double-blind, placebo-controlled, crossover study. Stallions receiving FoalMaker showed about a 30% improvement in per-cycle conception rate compared with the control group at the midpoint. The report also described increases in total sperm count in certain stallions and noted that thousands of ejaculates had been analyzed.
Mares were bred by artificial insemination using a controlled number of sperm cells. The report treated the sperm-count change as separate from the conception-rate change. That is a stronger reading than “the stallions simply produced more sperm.”
A published article by the developers discusses experience with a glucosamine-containing equine reproductive supplement identified as FoalMaker. The authors reported experience, along with faculty from two veterinary teaching hospitals, indicating a positive influence on per-cycle conception rates and total sperm per ejaculate, without observed negative effects on stallion health. At the time that article was written, those data were described as submitted for publication.
The same article discusses use in reproductively difficult mares, including mares previously bred that remained barren. Those mare observations are clinical and field experience. They are not equivalent to the controlled stallion trial.
The female-reproduction literature cited around FoalMaker covers glucosamine and N-acetylglucosamine, glycosaminoglycans, cumulus expansion, oocyte maturation, sperm–egg interaction, zona pellucida biology, and fertilization. Cited work reports that glucosamine-related pathways participate in cumulus-oocyte complex expansion, and that disrupting glucosamine synthesis can inhibit cumulus expansion and suppress ovulation in experimental systems. Other cited work examines glycosaminoglycan production in bovine cumulus-oocyte complexes.
That is useful mechanistic support. It should stay separate from claims of demonstrated FoalMaker efficacy. The male-reproduction bibliography includes N-acetylglucosamine and sperm physiology across species, and equine work on stallion sperm binding to oviductal epithelial cells.
➔ Nie et al., JACN 2003, Abstract 79 — direct controlled study of FoalMaker in breeding stallions.
➔ 2003 AAVN/ACVIM presentation — the same FoalMaker research presented scientifically.
➔ American College of Nutrition poster — the same research as a scientific poster.
➔ 2002 DVM360 report — midpoint controlled-trial results, about 30% improved per-cycle conception.
➔ Multi-year commercial field work — additional experience with conception rates and sperm output.
➔ Published glucosamine and GAG reproductive literature — biological plausibility, not a finished-product trial.
➔ Problem-mare clinical experience — supportive observations, weaker evidence.
62.5% is the relative increase from 24% pregnancies per cycle before supplementation to 39% during supplementation in the stallions assigned to FoalMaker. It is not a 62.5-point jump.
The calculation is (39% − 24%) ÷ 24% = 62.5% relative improvement. That 24% to 39% comparison appears in the patent’s detailed description of the study. Treatment-group stallions settled mares in 83 of 351 cycles (24%) in 2000, before supplementation, versus 86 of 223 cycles (39%) in 2001 while receiving the supplement. (In other words: there was no statistical change in the non-supplemented control stallions, but those getting FoalMaker created MORE pregnancies, with 128 FEWER cycles!)
The study involved 12 Tennessee Walking Horse stallions at a commercial breeding farm in middle Tennessee. Stallions were grouped by age and randomized to treatment or control for the 2001 season. Farm personnel were blinded to treatment assignment. Treated stallions received the nutritional supplement. Controls received an inert placebo. Supplement or placebo was divided between morning and evening feedings.
All mares in the fertility analysis were bred by artificial insemination with fresh semen, not by live cover. Semen volume, concentration, motility, morphology, and viability were evaluated. Pregnancy was confirmed at about day 16. Pregnancy data were analyzed with a mixed-model repeated-measures procedure, with stallion included as a random factor.
➔ Before supplementation: 83 of 351 breeding cycles — 24% pregnancies per cycle.
➔ During supplementation: 86 of 223 breeding cycles — 39% pregnancies per cycle.
➔ That is 15 percentage points greater, and a 62.5% relative improvement.
➔ During the defined T2–T4 treatment periods, the supplemented stallions’ improvement versus their own previous season was reported as statistically significant (P<0.05).
➔ Fertility among controls stayed essentially unchanged. The direct treated-versus-placebo comparison in 2001 was not statistically significant (P>0.05). The investigators noted that loss of two control stallions reduced the control group and may have limited statistical power.
Mean sperm motility, sperm concentration, and total sperm number were not significantly different between treatment and control stallions over the evaluation period. Because mares were bred by artificial insemination under controlled breeding management, the investigators concluded that the pregnancy-rate increase could not simply be attributed to production of a greater total number of sperm.
➔ JACN Abstract 79 — Nie et al., Journal of the American College of Nutrition, 2003;22(5):475. The issue table of contents is the public journal record. Abstract 79 is the FoalMaker stallion abstract on page 475.
➔ 2003 AAVN/ACVIM presentation — American Academy of Veterinary Nutrition Clinical Nutrition and Research Symposium, held with the ACVIM Annual Meeting in Charlotte, North Carolina. A separate 2003 abstract page is not posted. ACVIM is the meeting host.
➔ American College of Nutrition poster — 44th Annual Symposium on Advances in Clinical Nutrition, October 2003. The College is now the American Nutrition Association. A separate poster file is not posted.
➔ U.S. Patent 7,776,366 B2 — issued patent with the 24% to 39% study numbers.
➔ U.S. Patent Application US20040156923A1 — Method and Nutraceutical Composition for Mammals, Davenport and Martin, assigned to MD's Choice, Inc.
➔ FoalMaker on MD's Choice — current product page for the stallion and mare reproduction packets.
➔ Research page — the same citations, with the patent section last.
Nie G, Rohrback B, Wenzel J, Bennett B, Bailey J, Martin J, Davenport D. Effect of Feeding a Nutritional Supplement (FoalMaker™) to Breeding Stallions on Semen Quality and Pregnancies per Cycle in a Double Blind, Placebo Controlled Study. Journal of the American College of Nutrition. 2003;22(5):475. Abstract 79.
The same work was presented at the 2003 American Academy of Veterinary Nutrition Clinical Nutrition and Research Symposium, held with the ACVIM Annual Meeting in Charlotte, North Carolina, and as a scientific poster at the American College of Nutrition’s 44th Annual Symposium on Advances in Clinical Nutrition in October 2003.
The study and supporting experimental data are also described in U.S. Patent Application US20040156923A1, Method and Nutraceutical Composition for Mammals, filed by David F. Davenport and J. Eric Martin and assigned to MD’s Choice, Inc. A subsequent patent issued as U.S. Patent No. 7,776,366.
Scientifically precise conclusion: stallions receiving the FoalMaker nutritional formulation increased pregnancies per breeding cycle from 24% in the preceding season to 39% during supplementation, a 62.5% relative improvement. The within-treatment historical comparison was statistically significant during the principal treatment periods. The contemporaneous treatment-versus-placebo difference did not reach statistical significance. (In other words: there was no statistical change in the non-supplemented control stallions, but those getting FoalMaker created MORE pregnancies, with 128 FEWER cycles!)
➔ Journal of the American College of Nutrition, 2003, volume 22, issue 5 — the issue that carries Abstract 79, page 475. A separate public abstract page for Abstract 79 was not found.
➔ Google Scholar search for Nie et al., Abstract 79.
➔ ACVIM — host of the 2003 AAVN Clinical Nutrition and Research Symposium in Charlotte. A public proceedings file for that FoalMaker presentation was not found.
➔ American Nutrition Association — current organization of the former American College of Nutrition, host of the 44th Annual Symposium poster. A public poster file was not found.
➔ U.S. Patent 7,776,366 B2 and the earlier application US20040156923A1.
➔ It does mean the pregnancy-per-cycle rate rose from 24% to 39% in the treatment stallions. That equals a 62.5% relative improvement.
➔ It does not mean 62.5 percentage points were added. The result was not 24% to 86.5%. It was 24% to 39%.
➔ It should not be described as a 62.5% improvement demonstrated in Thoroughbred stallions. The controlled population documented in the patent was Tennessee Walking Horses.
➔ It should not be described as proven under live-cover Thoroughbred conditions. The study used artificial insemination with fresh semen.
An older MD’s Choice brochure states that documentation from studies over four years, involving more than 30 commercial stallions, showed an average 62.5% improvement in per-cycle conception rates. The underlying datasets or separate peer-reviewed publications covering all 30-plus stallions have not been located here. That statement is best classed as company-reported field documentation, not as a peer-reviewed publication that independently documents 30-plus stallions.
The strongest independently traceable chain is: 12-stallion commercial controlled study, JACN Abstract 79, AAVN/ACVIM presentation, American College of Nutrition poster, detailed numbers in the patent, then later company field documentation extending experience to 30-plus commercial stallions.
A fertility or conception claim on a commercial feed label can raise animal-food regulatory issues. A careful on-label line is “Studied in breeding stallions in a blinded, placebo-controlled commercial breeding study,” rather than a large 62.5% efficacy claim, unless feed-control counsel has cleared that wording.
This is the educational sheet that accompanied the FoalMaker work. It is company nutrition education, not a new peer-reviewed paper.
Providing optimal nutritional input will enhance reproductive performance. High quality protein intake concurrent with energy intake to maintain a body condition score (BCS) of 5.5–7.5 is critical for reproductive success. Due to increased nutrient requirements for breeding stallions and mares in late gestation, a high quality (nutrient dense) feeding program must be utilized to maintain an appropriate BCS. Supplementation should not be used to try to make a poor ration excellent. In addition to protein and energy needs, vitamin and mineral intake needs to be optimized. Mares in the last trimester of gestation need approx. 85% more calcium and phosphorus than in the first two trimesters.
When you want to do everything possible nutritionally to ensure optimal reproductive performance in both mares and stallions, there are some nutrients that are more likely to be limiting in individuals. The following nutrients can be safely and effectively supplemented orally. Just providing more of everything is not optimizing a feeding program.
There are several basic molecules that are present in many different reproductive cells and tissues. Most of these are not available in a purified, supplemental form. Others that may be available are either not economical or are not absorbed efficiently.
Glucosamine is a very small “building block” type nutrient that is found ubiquitously in mammalian tissues. It is actively concentrated in some tissues such as connective tissues and all mucosal linings. Many important reproductive cells and structures contain large concentrations of glucosamine. Simply identifying a basic nutrient that is heavily involved with several stages of reproduction does not make it a good supplement. Most of the glucosamine-containing structures mentioned contain the acetylated form of glucosamine linked together by sulphur bonds. However, this form has been shown to be highly utilized in the digestive tract, with little being absorbed. Any absorption of this form occurs via passive diffusion. Glucosamine Sulphate is, however, absorbed actively from the digestive tract using a glucose transporter. This active absorption has been documented to be over 90% efficient within 30 minutes in at least 3 species. The acetylation of Glucosamine Sulphate as well as its conversion to galactosamine is readily performed in most tissues.
Supplying large amounts of a purified nutrient may not positively affect the desired systems and can have negative effects. There are several anecdotal accounts of both chondroitin sulfate and injectable PSGAGs causing decreased stallion reproductive performance. There is no verification of these theories in the literature, but a reaction to these larger molecules by some individual stallions may explain these reports. However, MD's Choice, along with faculty from 2 veterinary teaching hospitals, researched FoalMaker™ and reported a positive influence on per-cycle conception rates and total sperm per ejaculate, with no negative effects on stallion health (data submitted for publication at the time of that sheet). While several mares that had been bred but barren for several years became pregnant during supplementation, one or two cases did lose the foal when the owners discontinued the use of the product.
➔ Lining of the uterus and cervix
➔ Zona pellucida of the egg
➔ Attachment site of egg to sperm
➔ Implantation site of the embryo into the uterus
➔ Cell to cell adhesion in early development of the cumulus mass
➔ Testes, sperm membrane, and seminal fluid
➔ Acrosomal end of the sperm
➔ Sperm-egg attachment site
➔ Major role in the acrosomal reaction
Several vitamins and minerals are associated with increased reproductive performance in both males and females. The form that minerals are supplied in is critical. All of the minerals listed below have reported toxic effects on reproduction when exposure is to the inorganic forms, and beneficial effects when exposure is from organic forms.
Biotin has been heavily researched in many species with respect to its effect on female reproductive performance parameters and gamete development. The most well documented effects are on sow conception rates and return to estrus post parturition. Many effects of biotin on prenatal development have also been established.
Boron is a good example of a nutrient that is beneficial to the spermatogenic cycle, embryonic, and fetal development when provided in an organic form. However, exposure to an inorganic form, testicular damage and mutagenic effects are common. Boron is involved in the production of many sex hormones.
Chromium deficiency can cause a decrease in sperm count, but exposure to inorganic forms can cause severe testicular damage, improper testicular development, or neoplasia. Many positive effects on female reproductive efficiencies and lactation improvements have been found.
Folic acid plays critical roles in the normal reproduction of cells. A deficiency of folate has been associated with defects in pre-implantation embryos and the neural, skeletal, digestive and urinary tracts of developing fetuses.
Manganese plays a large part in attachment and conception. Exposure to inorganic manganese causes reduced male fertility.
Thiamine is crucial to the viability and motility of sperm. Normal development in the uterus depends on the presence of thiamine.
Zinc deficiency has negative effects on testosterone levels and sperm development. Exposure to inorganic zinc causes harm to reproductive tissues.
Dr. David F. Davenport, D.V.M., M.S. (Ag. Econ), M.S. (Nutrition), C.N.S. is the C.E.O. of MD's Choice. He learned how important nutrition is to general health and wellness through working with animals. He has spent many years in graduate coursework and research learning how to apply cutting-edge nutrition to clinical and preventive health care programs for both people and animals. Dr. Davenport is a board certified human nutrition specialist (C.N.S.) through the American College of Nutrition.
Dr. J. Eric Martin, D.V.M., M.S. (Nutrition) is Vice President of Research & Development for MD's Choice. He has added to the knowledge he gained as a veterinarian through years of additional graduate training in research and clinical nutrition for both people and animals. Dr. Martin's clinical experience has given him confidence to promote problem prevention vs. continual treatment of symptoms.
Dr. Michael R. Bishop, M.D., Ph.D., FACOG (OB/GYN) graduated as a Pharmacist from Purdue before obtaining both a Ph.D. in Pharmacology and Biochemistry and an M.D. from Vanderbilt. He is a clinical instructor, a published surgeon and frequent speaker at scientific meetings. Over the past several years, Dr. Bishop has turned much of his attention to preventive health and now contributes his clinical experience to the team at MD's Choice.