UMIN-CTR Clinical Trial

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