BloodpressureNCT03008785
Effect of Isoflavone Supplementation Associated With Physical Exercise in the Health Parameters of Postmenopausal Women
A study testing exercise and isoflavone in people with Bloodpressure, run by Federal University of Uberlandia at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bloodpressure
- What is being tested?
- exercise and isoflavone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- smokers
- use hormone therapy or isoflavone
- use drugs that interfere with lipid and antihypertensive metabolism
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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
- Conditions
- Bloodpressure
- Being tested
- exercise, isoflavone, Placebo
- Keywords
- isoflavone, blood pressure, climateric symptoms, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
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.
isoflavoneOther
Daily supplementation in 1 capsule per day of 100mg of isoflavones (containing 3.3% genistein, 93.5% dadzein and 3.2% glycitein).
PlaceboOther
Daily supplementation in 1 capsule per day containing starch of corn.
| Study group | Role | What they receive |
|---|---|---|
| group isoflavone and exercise | Experimental | The isoflavone group received daily 100mg of isoflavones. Receives: Other: exercise; Other: isoflavone |
| group placebo and exercise | Experimental | The placebo group received 100mg containing starch of corn. Receives: Other: exercise; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure
Evaluate change in blood pressure through ambulatory 24-hour blood pressure monitoring used before the begin of intervention and after 10 weeks.
Measured: Change in blood pressure in 10 weeks intervention
Secondary outcomes (10)
Climateric Symptoms (Kupperman-Blatt Index)
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 .
Measured: before and after 10 weeks
Climateric Symptoms (Cervantes Scale)
Evaluate the intensity of climateric symptoms using the Cervantes Scale questionnaire. Composed of 31 questions distributed in four domains and 6 possibilities of answer.
Measured: before the begin the intervention and after 10 weeks
Climateric Symptoms (Menopause Rating Scale)
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
Measured: before and after 10 weeks
Lipid profile (enzymatic colorimetric method)
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.
Measured: before and after 10 weeks
Human cytokines (Flow Cytometry)
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.
Measured: before and after 10 weeks
Antioxidant capacity
The total antioxidant capacity will be evaluated in plasma and saliva using the FRAP (Ferric-Absorbing Ability of Plasma) methodology (Benzie and Strain, 1999).
Measured: before and after 10 weeks
Total protein
The determination of the total salivary and plasma protein will be performed by the Bradfort method (Bradford, 1976) adapted for microplate
Measured: before and after 10 weeks
Body Composition
Bioelectrical impedance (Biodynamics, model 450c, EUA) will be used to determine absolute and relative extracellular mass and body cell mass.
Measured: before and after 10 weeks
Phase Angle
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)
Measured: before and after 10 weeks
Oxidative stress (SOD, Catalase and TBARS activity)
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).
Measured: before and after 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startFeb 2015
- Primary completionJul 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BloodpressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliene Gonçalves Costa, Federal University of Uberlandia
- Investigators
- Guilherme Puga, PhD, Principal investigator, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008785
- Sponsor's protocol ID
- CAAE: 40622414.9.0000.5152
- Status last verified
- Feb 2019
- First submitted
- 28 Dec 2016
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Acharjee S, Zhou JR, Elajami TK, Welty FK. Effect of soy nuts and equol status on blood pressure, lipids and inflammation in postmenopausal women stratified by metabolic syndrome status. Metabolism. 2015 Feb;64(2):236-43. doi: 10.1016/j.metabol.2014.09.005. Epub 2014 Oct 5.
PubMed 25441251Lebon J, Riesco E, Tessier D, Dionne IJ. Additive effects of isoflavones and exercise training on inflammatory cytokines and body composition in overweight and obese postmenopausal women: a randomized controlled trial. Menopause. 2014 Aug;21(8):869-75. doi: 10.1097/GME.0000000000000177.
PubMed 24378766Barbosa CD, Costa JG, Giolo JS, Rossato LT, Nahas PC, Mariano IM, Batista JP, Puga GM, de Oliveira EP. Isoflavone supplementation plus combined aerobic and resistance exercise do not change phase angle values in postmenopausal women: A randomized placebo-controlled clinical trial. Exp Gerontol. 2019 Mar;117:31-37. doi: 10.1016/j.exger.2018.08.007. Epub 2018 Sep 1.
PubMed 30176281
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03008785
- Acronym / sponsor ID
- CAAE: 40622414.9.0000.5152
- Conditions
- Bloodpressure
- Keywords
- isoflavone, blood pressure, climateric symptoms, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group isoflavone and exercise | Experimental | Other: exercise, Other: isoflavoneThe isoflavone group received daily 100mg of isoflavones. |
| group placebo and exercise | Experimental | Other: exercise, Other: PlaceboThe placebo group received 100mg containing starch of corn. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- smokers
- use hormone therapy or isoflavone
- use drugs that interfere with lipid and antihypertensive metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exerciseThe 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. | Other | group isoflavone and exercise, group placebo and exercise |
| isoflavoneDaily supplementation in 1 capsule per day of 100mg of isoflavones (containing 3.3% genistein, 93.5% dadzein and 3.2% glycitein). | Other | group isoflavone and exercise |
| PlaceboDaily supplementation in 1 capsule per day containing starch of corn. | Other | group placebo and exercise |
Primary outcome
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.
10 secondary outcomes
Climateric Symptoms (Kupperman-Blatt Index)
Time frame: before and after 10 weeks
Climateric Symptoms (Cervantes Scale)
Time frame: before the begin the intervention and after 10 weeks
Climateric Symptoms (Menopause Rating Scale)
Time frame: before and after 10 weeks
Lipid profile (enzymatic colorimetric method)
Time frame: before and after 10 weeks
Human cytokines (Flow Cytometry)
Time frame: before and after 10 weeks
Antioxidant capacity
Time frame: before and after 10 weeks
Total protein
Time frame: before and after 10 weeks
Body Composition
Time frame: before and after 10 weeks
Phase Angle
Time frame: before and after 10 weeks
Oxidative stress (SOD, Catalase and TBARS activity)
Time frame: before and after 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Background: PubMed 25441251Acharjee S, Zhou JR, Elajami TK, Welty FK. Effect of soy nuts and equol status on blood pressure, lipids and inflammation in postmenopausal women stratified by metabolic syndrome status. Metabolism. 2015 Feb;64(2):236-43. doi: 10.1016/j.metabol.2014.09.005. Epub 2014 Oct 5.
- Results publication: PubMed 24378766Lebon J, Riesco E, Tessier D, Dionne IJ. Additive effects of isoflavones and exercise training on inflammatory cytokines and body composition in overweight and obese postmenopausal women: a randomized controlled trial. Menopause. 2014 Aug;21(8):869-75. doi: 10.1097/GME.0000000000000177.
- Derived from this study: PubMed 30176281Barbosa CD, Costa JG, Giolo JS, Rossato LT, Nahas PC, Mariano IM, Batista JP, Puga GM, de Oliveira EP. Isoflavone supplementation plus combined aerobic and resistance exercise do not change phase angle values in postmenopausal women: A randomized placebo-controlled clinical trial. Exp Gerontol. 2019 Mar;117:31-37. doi: 10.1016/j.exger.2018.08.007. Epub 2018 Sep 1.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guilherme Puga, PhD principal investigator
Federal University of Uberlandia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise and isoflavone in people with Bloodpressure, run by Federal University of Uberlandia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood pressure (time frame: Change in blood pressure in 10 weeks intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03008785, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019.