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Trial record 9 of 9 for:    red clover

Phytoestrogen Supplementation in Postmenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01497977
Recruitment Status : Completed
First Posted : December 23, 2011
Last Update Posted : December 29, 2011
Information provided by (Responsible Party):
Tihomir Mihailovic, American Medical Academy, Serbia

Brief 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.

Condition or disease Intervention/treatment Phase
Low Serum Lipid Levels Drug: phytoestrogens Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Impact of Phytoestrogens on Serum Lipids in Postmenopausal Women
Study Start Date : September 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Arm Intervention/treatment
Experimental: soya phytoestrogens Drug: phytoestrogens
The soya daily dose contained 2 isoflavones: genistein (39mg) and daidzein (1mg).
Other Name: isoflavones

Experimental: red clover phytoestrogens Drug: phytoestrogens
The red clover capsule consisted of 4 isoflavones: biokain A (23mg), daidzein (1mg), formononetin (15mg) and genistein (1mg).
Other Name: isoflavones

No Intervention: No drugs

Primary Outcome Measures :
  1. Change from baseline of serum lipids [ Time Frame: 18 months ]
    study begining, 6 months, 12 months, 18 months

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy postmenopausal women, not taking any medications (anti-osteoporotic, lipid-lowering, anti-hypertensive and hormone based) that could influence the study results, last menstrual cycle of the investigated women was at least 12 months before entering the study.

Exclusion Criteria:

  • unfulfilled inclusion criteria at any time of the study, allergies or severe adverse reactions on the administered drugs, changing of the regular dietary habits, the study protocol interruption and the wish of the patient to withdraw from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01497977

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Ultramedica Clinic, American Medical Academy
Belgrade, Serbia, 11000
Sponsors and Collaborators
American Medical Academy, Serbia
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Study Director: Tihomir Mihailovic, MD.PhD Ultramedica Clinic, American Medical Academy
Principal Investigator: Milan Terzic, Prof. dr School of Medicine, University of Belgrade

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Responsible Party: Tihomir Mihailovic, Dr, American Medical Academy, Serbia Identifier: NCT01497977     History of Changes
Other Study ID Numbers: 175062
First Posted: December 23, 2011    Key Record Dates
Last Update Posted: December 29, 2011
Last Verified: December 2011

Keywords provided by Tihomir Mihailovic, American Medical Academy, Serbia:
serum lipids

Additional relevant MeSH terms:
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Estrogens, Non-Steroidal
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs