geniVida® (non-soy genistein)

Evidence ratings on NutraSmarts are based on the totality of human clinical research, with emphasis on randomized controlled trials, meta-analyses, and systematic reviews. The references below directly support claims made throughout this page.

1. Marini H, Minutoli L, Polito F, Bitto A, Altavilla D, Atteritano M, et al. Effects of the phytoestrogen genistein on bone metabolism in osteopenic postmenopausal women: a randomized trial. Annals of Internal Medicine. 2007;Ann Intern Med. 2007 Jun 19;146(12):839-47..PubMedUsed to support: Pivotal 24-month bone density RCT of a natural-source genistein aglycone, the same molecule the branded ingredient supplies. It did not test the branded ingredient itself, and it shares eight authors with the hot flush trial below.
2. Crisafulli A, Marini H, Bitto A, Altavilla D, Squadrito G, Romeo A, et al. Effects of genistein on hot flushes in early postmenopausal women: a randomized, double-blind EPT- and placebo-controlled study. Menopause. 2004;Menopause. 2004 Jul-Aug;11(4):400-4..PubMedUsed to support: 12-month hot flush RCT of the parent compound, from largely the same authors as the bone trial. It did not test the branded ingredient itself, and it also measured endometrial thickness, which did not increase.
3. Evans M, Elliott JG, Sharma P, et al. The effect of synthetic genistein on menopause symptom management in healthy postmenopausal women: a multi-center, randomized, placebo-controlled study. Maturitas. 2011;68(2):189-96..PubMedUsed to support: The only randomized trial of the branded material itself, which the page currently omits entirely: 84 postmenopausal women given a single daily 30 mg dose of synthetic genistein or placebo for 12 weeks. Hot flushes fell about 51 percent in the genistein arm (9.4 to 4.7 per day) against about 27 percent on placebo (9.9 to 7.1 per day), p=0.026, with significantly fewer flushes per day (p=0.010) and shorter total daily duration (p=0.009); among the 32 genistein subjects who finished all 12 weeks it was 51 percent against 30 percent, p=0.049. There were no differences between groups in Greene Climacteric Scale, FSH, 17-beta-estradiol, endometrial thickness or adverse events. Limitations to keep with it: results are reported for the women who stayed on treatment (40 at 4 weeks and 32 at 12 weeks in the genistein arm) rather than for all 84 randomized, the study was run by a contract research organization, and the paper itself says only synthetic genistein; DSM's 2011 press release is what identifies the test material as geniVida.
4. Atteritano M, Mazzaferro S, Bitto A, et al. Genistein effects on quality of life and depression symptoms in osteopenic postmenopausal women: a 2-year randomized, double-blind, controlled study. Osteoporos Int. 2014;25(3):1123-9..PubMedUsed to support: The missing citation for the quality-of-life benefit: 262 osteopenic postmenopausal women aged 49 to 67, 54 mg/day genistein or placebo for 2 years, assessed with the Short Form 36 and the Zung Self-rating Depression Scale at baseline, 1 year and final visit. SF-36 scores rose on all dimensions in the genistein group while placebo scores fell, and the between-group differences were statistically significant on both instruments. It comes from the same Messina research group and the same 54 mg parent-compound programme as the bone trial and did not test the branded ingredient, so cite it as supporting evidence rather than independent confirmation.
5. Marini H, Bitto A, Altavilla D, et al. Breast safety and efficacy of genistein aglycone for postmenopausal bone loss: a follow-up study. J Clin Endocrinol Metab. 2008;93(12):4787-96..PubMedUsed to support: Third-year extension of the 24-month bone trial in a subcohort of 138 women, 71 on 54 mg/day genistein aglycone and 67 on placebo, both arms receiving calcium and vitamin D3. Mammographic density was assessed at baseline, 24 and 36 months by visual classification and digitized quantification, alongside BRCA1 and BRCA2 expression, sister chromatid exchange and endometrial thickness. After 36 months genistein did not significantly change mammographic breast density or endometrial thickness, BRCA1 and BRCA2 expression was preserved, sister chromatid exchange was reduced versus placebo, bone mineral density gains continued and there were no differences in discomfort or adverse events between groups. This is the strongest published human safety datum at the 54 mg dose and the page's safety section should rest on it rather than on a one-line theoretical caution. Disclose the funding: the work was supported in part by Primus Pharmaceuticals, and two authors (Burnett, Levy) worked for Primus, which markets a genistein aglycone product.
6. Bitto A, Burnett BP, Polito F, et al. The steady-state serum concentration of genistein aglycone is affected by formulation: a bioequivalence study of bone products. Biomed Res Int. 2013;2013:273498..PubMedUsed to support: Cited for the bridging caveat rather than for any benefit. Thirty healthy postmenopausal women took 54 mg of genistein a day for 8 days in one of three formulations. The formulation used in the Messina trials is described here as containing natural genistein at about 99 percent purity, which is the only published description of the source of the trial material; the trial reports themselves state only that purity exceeded 98 percent. An over-the-counter product built on synthetic genistein at the same purity was not bioequivalent to it: Tmax 6 hours versus 2, half-life 8.3 versus 21 hours, and AUC 6474 versus 9818 ng.hr/mL, about a third lower. The authors attribute the difference to the other ingredients in the OTC product rather than to the origin of the genistein, which is fair, but it shows that equal purity does not by itself guarantee equal blood levels. That is the honest limit of the identical-molecule argument for a non-soy genistein, and no such comparison has been published for this branded ingredient. Same research group and the same Primus-linked authors, so read it with that in mind.