UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046596 |
|---|---|
| Receipt number | 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 21:53:01 |
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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
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/
info@shahroodut.ac.ir
Sponsor or person
Institute
Shahrood University of Technology-Financing
Imam Hussein Clinic-Sample supply
Dr. Nasrin Razavianzadeh-sample supply
Razavi Clinic-sample supply
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053128
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