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Feasibility, Safety and Acceptability of Soy-Based Diet for Pregnant Women: Preliminary Results from a Pilot Randomized Controlled Trial
UMass Center for Clinical and Translational Science Research Retreat
  • Ling Shi, University of Massachusetts Boston
  • Vidya Iyer, Tufts Medical Center
  • Errol Norwitz, Tufts Medical Center
  • Tiffany A. Moore Simas, University of Massachusetts Medical School
  • Nirupa R. Matthan, Tufts University
  • Alice H. Lichtenstein, Tufts University
  • Laura L. Hayman, University of Massachusetts Boston
Start Date
16-5-2017 1:45 PM
Document Type
Poster Abstract
Background: Previous evidence suggests that soy containing foods may have beneficial effects on lipid and glycemic metabolism. Pregnancy is associated with a progressive deterioration in glucose and lipid metabolism, partially attributable to elevated estrogen concentrations. Little is known about the effects of soy intake on cardiometabolic risk factors in pregnant women. Methods: A pilot RCT was conducted in 30 pregnant women who were randomized to receive counseling to consume a high-soy or low-soy foods containing diet. Assessments (physical measurements, food frequency questionnaires, fasting blood samples) were conducted at 14 and 28 weeks of pregnancy, and 6 weeks’ postpartum. Monthly follow-up calls were conducted to assess safety and encourage adherence. Results: Both the high-soy and low-soy groups demonstrated high adherence (80-90%), defined as consuming soy foods ≥ 15 days in the past four weeks for high-soy group and ≤ 5 days for low-soy group. Five adverse events possibly associated with soy intake were reported (nausea, vomiting, diarrhea, itchy mouth); all were transient and resolved without sequelae. The high-soy group lost body fat between baseline and postpartum while the low-soy group gained body fat, as reflected by change in triceps skinfold thickness (-4.8 mm vs +3.6 mm, p=0.04). There was a trend towards an improvement in BMI in the high-soy group, both at 28 weeks (+1.4 vs. +3.6 kg/m2, p=0.15) and postpartum (-1.2 vs. +0.6 kg/m2, p=0.14). There were no differences between groups in fasting glucose, HDL-C, LDL-C, TG, or VLDL levels. Conclusion: Initial results from this pilot RCT support the acceptability and safety of consuming soy-based whole foods during pregnancy. A larger-scale RCT is needed to further elucidate the effects of soy diet on cardiometabolic risk among pregnant women.
  • pregnant women,
  • diet,
  • soy,
  • cardiometabolic risk factors
Creative Commons License
Creative Commons Attribution-Noncommercial-Share Alike 3.0
Citation Information
Ling Shi, Vidya Iyer, Errol Norwitz, Tiffany A. Moore Simas, et al.. "Feasibility, Safety and Acceptability of Soy-Based Diet for Pregnant Women: Preliminary Results from a Pilot Randomized Controlled Trial" (2017)
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