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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046596
Receipt No. R000053128
Scientific Title The effect of eight weeks of Pilates training and consumption of jujube extract on the indicators of metabolic syndrome in middle-aged women
Date of disclosure of the study information 2022/07/20
Last modified on 2022/01/10

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Basic information
Public title The effect of eight weeks of Pilates training and consumption of jujube extract on the indicators of metabolic syndrome in middle-aged women
Acronym The effect of training and consumption of jujube extract on the indicators of metabolic syndrome
Scientific Title The effect of eight weeks of Pilates training and consumption of jujube extract on the indicators of metabolic syndrome in middle-aged women
Scientific Title:Acronym The effect of training and consumption of jujube extract on the indicators of metabolic syndrome
Region
Asia(except Japan)

Condition
Condition Triglycerides equal to or greater than 150 mg / dl or specific therapy.
Hypertension (diastolic blood pressure equal to or greater than 85 mm Hg and systolic blood pressure equal to or greater than 130 mm Hg) or taking antihypertensive drugs.
HDL cholesterol less than 40 mg / dl in men and less than 50 mg / dl in women or medication.
Fasting sugar equal to or greater than 100 mg / dl or taking anti-diabetic medication
Classification by specialty
Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Improves lipid profile, waistline, blood sugar and blood pressure
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Phase III

Assessment
Primary outcomes does not have
Key secondary outcomes Lower blood pressure, lower blood sugar, lower abdominal circumference, lower blood lipids

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Food Other
Interventions/Control_1 Intervention 1: Pilates exercises
These exercises are three sessions a week and one hour. Stretching exercises with basic breathing include selected Pilates exercises.
Interventions/Control_2 Intervention 2: Jujube extract
This extract in the amount of 200 mg per kg of body weight will be consumed daily before meals for 8 weeks.
Interventions/Control_3 Intervention 3: Jujube extract and Pilates exercises
This group receives Pilates exercises and jujube extract together.
Similar to other groups, the total duration of training and consumption of jujube extract is 8 weeks.
Exercises 3 sessions per week, one hour and the extract received 200 mg per kg of body weight and daily, before meals.
Interventions/Control_4 Control
There will be no intervention in this group, middle-aged women with metabolic syndrome will continue their lifestyle for only 8 weeks
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit
60 years-old >=
Gender Female
Key inclusion criteria Subjects should have at least three factors related to metabolic syndrome.
Subjects should not have any regular physical activity for at least three months.
All participants in the study should be standardized in terms of height, weight, BMI, waist and having the relevant criteria and have abdominal obesity.
Key exclusion criteria 1- Pregnancy in women
2_ Lack of at least three of the few factors related to metabolic syndrome
3_ BMI <25 and waist less than 88
History of angina, myocardial infarction or stroke, heart attack, kidney disease and thyroid disease during the last year
Target sample size 60

Research contact person
Name of lead principal investigator
1st name melika
Middle name
Last name anabi
Organization Shahrood University of Technology
Division name shahrood
Zip code 3619995161
Address Shahrood Haft Tir Square, Shahrood University of Technology
TEL 9809128735646
Email m.anabi@shahroodut.ac.ir

Public contact
Name of contact person
1st name melika
Middle name
Last name anabi
Organization Shahrood University of Technology
Division name shahrood
Zip code 3619995161
Address Shahrood Haft Tir Square, Shahrood University of Technology
TEL 9809128735646
Homepage URL https://shahroodut.ac.ir/fa/
Email info@shahroodut.ac.ir

Sponsor
Institute Shahrood University of Technology-Financing
Imam Hussein Clinic-Sample supply
Dr. Nasrin Razavianzadeh-sample supply
Razavi Clinic-sample supply
Institute
Department

Funding Source
Organization Shahrood University of Technology
shahrood
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Ministry of Science

Other related organizations
Co-sponsor Imam Hussein Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization Physical Education Research Institute
Address No. 3, Fifth Alley, Mir Emad St., Ostad Motahhari St., Tehran
Tel +9802188747632 - +9802188747793 - +9802188747836
Email info@ssrc.ac.ir

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions Shahrood University of Technology (Shahrood)
Imam Hossein Clinic (Shahrood)
Razavi Clinic (Shahrood)

Other administrative information
Date of disclosure of the study information
2022 Year 07 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason Blood sampling will be delayed or delayed if the relevant dates are moved slightly.
Date of the first journal publication of results
2022 Year 07 Month 20 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2020 Year 01 Month 28 Day
Date of IRB
2021 Year 02 Month 07 Day
Anticipated trial start date
2022 Year 03 Month 20 Day
Last follow-up date
2022 Year 05 Month 20 Day
Date of closure to data entry
2022 Year 05 Month 25 Day
Date trial data considered complete
2022 Year 05 Month 30 Day
Date analysis concluded
2022 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2022 Year 01 Month 10 Day
Last modified on
2022 Year 01 Month 10 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053128

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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