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NCT Number: NCT03008785

Effect of Isoflavone Supplementation Associated With Physical Exercise in the Health Parameters of Postmenopausal Women

This study evaluate if 10 weeks of mixed exercise combined with isoflavones could have greater effects on climacteric symptoms, body composition and hydratation, lipidic and inflamatory profile than exercise alone in postmenopausal women. the participants will be randomly assigned to the group: placebo and exercise or 100mg of isoflavone and exercise.

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Key information

Conditions

Bloodpressure Behavior Motor Activity

Age range

50 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Guilherme Morais Puga

Uberlândia, Minas Gerais, 38400-678, Brazil

About this study

Several endocrine metabolic changes occur during the climacteric period, due to the lack of estrogen and also by the aging process and some studies show that ingestion of isoflavones by postmenopausal women may have benefits. Theoretically the isoflavone potentiate the effects obtained during exercise

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy postmenopausal woman
  • to be able to practice exercises on treadmill and weight exercises
  • without physical complications that prevent the execution of physical exercises
  • have no history of cardiovascular disease, diabetes, renal pathologies or hypertension

Exclusion criteria

  • smokers
  • use hormone therapy or isoflavone
  • use drugs that interfere with lipid and antihypertensive metabolism

Treatment and study plan

Exercise

Other

The training program consisted of aerobic and resisted combined physical exercises performed during 10 weeks, three times weekly with 45 minutes sessions: 5 minutes of warm-up on treadmill, 20 minutes of aerobic exercises and 20 minutes of resistance exercises.

isoflavone

Other

Daily supplementation in 1 capsule per day of 100mg of isoflavones (containing 3.3% genistein, 93.5% dadzein and 3.2% glycitein).

Placebo

Other

Daily supplementation in 1 capsule per day containing starch of corn.

Primary outcomes

  1. Change in blood pressure

    Time frame: Change in blood pressure in 10 weeks intervention

    Evaluate change in blood pressure through ambulatory 24-hour blood pressure monitoring used before the begin of intervention and after 10 weeks.

Secondary outcomes

  1. Climateric Symptoms (Kupperman-Blatt Index)

    Time frame: before and after 10 weeks

    Evaluate the intensity of climateric symptoms using the Kupperman-Blatt Index questionnaire. Consists of 11 questions in which the symptoms are given numerical values according to their intensity .

  2. Climateric Symptoms (Cervantes Scale)

    Time frame: before the begin the intervention and after 10 weeks

    Evaluate the intensity of climateric symptoms using the Cervantes Scale questionnaire. Composed of 31 questions distributed in four domains and 6 possibilities of answer.

  3. Climateric Symptoms (Menopause Rating Scale)

    Time frame: before and after 10 weeks

    Evaluate the intensity of climateric symptoms using the Menopause Rating Scale questionnaire. Composed of eleven questions, with five possible answers, Symptoms divided into somatovegetative, psychological and urogenital domains may be classified as absent, mild, moderate, severe and very severe. With a general score ranging from 0 to 55 points

  4. Lipid profile (enzymatic colorimetric method)

    Time frame: before and after 10 weeks

    The concentrations in mg/dL of total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol and uric acid will be made through the enzymatic colorimetric method. The glucose will be analyzed by the enzymatic method and the glycated hemoglobin A1c by the turbidimetry method.

  5. Human cytokines (Flow Cytometry)

    Time frame: before and after 10 weeks

    Measurement in pg/mL of the production of human cytokines (IL-8, IL-1β, IL-6, TNF ( tumor necrosis factor), IL-10 and IL-12p70) in serum samples will be performed by the flow cytometry (FACSCantoII BDTM) Human Inflammatory Cytokines Kit "(BD ™ Cytometric Bead Array (CBA), BD Biosciences, San Jose, CA, USA) according to the manufacturer's instructions.

  6. Antioxidant capacity

    Time frame: before and after 10 weeks

    The total antioxidant capacity will be evaluated in plasma and saliva using the FRAP (Ferric-Absorbing Ability of Plasma) methodology (Benzie and Strain, 1999).

  7. Total protein

    Time frame: before and after 10 weeks

    The determination of the total salivary and plasma protein will be performed by the Bradfort method (Bradford, 1976) adapted for microplate

  8. Body Composition

    Time frame: before and after 10 weeks

    Bioelectrical impedance (Biodynamics, model 450c, EUA) will be used to determine absolute and relative extracellular mass and body cell mass.

  9. Phase Angle

    Time frame: before and after 10 weeks

    Phase angle in degrees (o) was calculated using the equation (Reactance/Resistance)

    *(180/л) using a values obtained on bioelectrical impedance (Biodynamics, model 450c, EUA)

  10. Oxidative stress (SOD, Catalase and TBARS activity)

    Time frame: before and after 10 weeks

    The enzyme superoxide dismutase (SOD) will be dosed from the auto oxidation capacity of pyrogallol, a process dependent on the superoxide radical (Fernandes et al., 2011). . Catalase activity in saliva will be determined based on the decrease in absorbance of hydrogen peroxide (H2O2) (Aebi, 1984). Thiobarbituric acid reactive substances (TBARS) will be detected by the Yagi method (Yagi, 1998).

Sponsors and collaborators

Lead sponsor

Federal University of Uberlandia

Other

Registry information

Official study title

Effect of Isoflavone Supplementation Associated With Physical Exercise on Blood Pressure, Lipic and Inflamatory Profile, Body Composition and Hydratation and Climacteric Symptoms in Postmenopausal Women

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 2, 2017
Registry last updated
Feb 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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