Low Serum Lipid Levels Clinical Trial
Official title:
Impact of Phytoestrogens on Serum Lipids in Postmenopausal Women
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.
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.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention