Phytoestrogen Supplementation in Postmenopausal Women
Condition: Low Serum Lipid Levels
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of the study was to assess the impact of soy and red clover derived phytoestrogens
      on serum lipids in postmenopausal women. Both soya and red clover have high phytoestrogen
      content. Phytoestrogens, a class of estrogenic molecules produced by plants bind to the
      estrogen receptor and are capable of producing estrogenic effects. Therefore, our hypothesis
      was that they can reduce the levels of serum lipids.

      Materials and Methods: Researchers investigated total cholesterol, cholesterol fractions and
      triglycerides in blood, before treatment and in six months periods, throughout 18 months. The
      study involved 74 healthy postmenopausal women, divided into three groups. The first group of
      23 patients received red clover derived isoflavones, the second one with 26 patients got soy
      derived phytoestrogens, while the third, control group with 25 patients, was without
      medications.
    

Detailed description: 
      A classic clinical sample was constructed. A total of 117 consecutive postmenopausal women
      who came to us in four months periods due to the postmenopausal symptoms (hot flushes, sleep
      disturbances, mood swings and vaginal dryness) were enlisted for the research. Out of them 74
      fulfilled the inclusion criteria and were randomized. Randomization process was simple manual
      and was done in the way that every woman with the odd randomization number received soya
      while those with the even randomization number received red clover derived isoflavones.
      However, during the study neither the doctors nor the patients knew what the randomization
      was and what the medication was. Women in the control group did not receive any medications
      and were only used for comparison. Examinees for this group were randomly selected from
      healthy postmenopausal women who had regular colposcopic check-ups during the same period.
      Out of 186 such women, 111 fulfilled the inclusion criteria, and every third was recruited
      for the study. In such way patients have been randomly divided in three groups (soya - S, red
      clover - RC, control - C) consisting of 37 women each. However, 6 women had to be excluded
      from soya and 5 from red clover group, as they did not take treatment on regular basis.
      Moreover, 7 women from soya, 6 from red clover and 9 from control group were excluded as a
      result of developing health problems (hypertension in 11 cases and uterine bleeding in 8
      cases and H-SIL in 3 cases). One woman from soya group wanted to start taking hormone
      replacement therapy. Three women decided to drop out from the control group. So, finally 23
      women from soya group, 26 from red clover and 25 from control group had undergone the study
      to the end.

      Women were taking one capsule per day of either soya or red clover derived phytoestrogens,
      early in the morning, before meal. The soya daily dose contained 2 isoflavones: genistein
      (39mg) and daidzein (1mg), while the red clover capsule consisted of 4 isoflavones: biokain A
      (23mg), daidzein (1mg), formononetin (15mg) and genistein (1mg). Each patient was keeping
      self-reported daily diary of the therapy administration, symptoms and adverse reactions.

      Researchers investigated total cholesterol, cholesterol fractions (LDL, HDL) and
      triglycerides, in cubital vein blood of patients, as well as body height and weight for each
      subject (out of which Body Mass Index - BMI was calculated by the standard formula). Data
      were recorded at the study beginning and 6, 12 and 18 months after the treatment
      commencement. Standard tests for lipid level evaluation were carried out on Olympus AU 400
      automatic analyzer with referral rates for triglycerides from 0,61 to 2,10 mmol/l, total
      cholesterol 3,63 - 6,46 mmol/l, HDL 0,75 - 1,99 mmol/l, LDL 1,60 - 4,78 mmol/l.
    

Intervention name(s): phytoestrogens; phytoestrogens
Intervention type(s): Drug; Drug
Intervention description(s): The red clover capsule consisted of 4 isoflavones: biokain A (23mg), daidzein (1mg), formononetin (15mg) and genistein (1mg).; The soya daily dose contained 2 isoflavones: genistein (39mg) and daidzein (1mg).
Other intervention name(s): isoflavones; isoflavones
Intervention MeSH terms: Phytoestrogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: phytoestrogens; postmenopause; serum lipids