Protocol summary

Study aim
• Comparison of the mean age, weight, height, BMI and blood pressure in each group and between the study groups before and after intervention, and comparison of mean changes between groups • Comparison of mean serum malondialdehyde in each group and between the study groups before and after intervention, and comparison of mean changes between groups • Comparison of mean serum total antioxidant capacity in each group and between the study groups before and after intervention, and comparison of mean changes between groups
Design
The present study is a phase 3 clinical trial with control group, parallel groups, double blind and randomized. in this study, 32 female with metabolic based on inclusion criteria and Permuted Block Randomization method randomly using random number table divided to 4 groups included aerobic training group, resveratrol supplement group, aerobic training + resveratrol group and control group.
Settings and conduct
The first group received 3 sessions (60 min) exercise and resveratrol placebo (oral paraffin 400 mg/Day), second group resveratrol 400 mg/day, the third group aerobic exercise + resveratrol, and fourth group resveratrol placebo for 8 weeks. Sampling perform from mokhaberat club in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being female; Age 18-50 years; Body Mass Index 18.5-29.9; patients with metabolic syndrome; No any other chronic diseases; no taking any drugs or special physical activity Exclusion criteria: Allergic reaction to resveratrol; pregnancy during the study; any changes in usual diet and life style or intake of multivitamin supplementation; withdrawal of the patient for cooperation
Intervention groups
1) Aerobic training group 2) Resveratrol supplement group 3) Aerobic training + resveratrol supplement group 4) Control group
Main outcome variables
Malondyaldeid serum level Total anti-oxidant capacity serum level

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190204042615N1
Registration date: 2019-02-18, 1397/11/29
Registration timing: retrospective

Last update: 2019-02-18, 1397/11/29
Update count: 0
Registration date
2019-02-18, 1397/11/29
Registrant information
Name
Mina Abdolahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3307 3626
Email address
abdolahimina.n@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
2018-06-18, 1397/03/28
Actual recruitment end date
2018-08-13, 1397/05/22
Trial completion date
2018-08-13, 1397/05/22
Scientific title
The effects aerobic training and resveratrol supplementation on oxidative stress in women with metabolic syndrome
Public title
The effect of aerobic training and resveratrol on metabolic syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being female Age 18-50 years Body Mass Index 18.5-29.9 Patients with metabolic syndrome No any other chronic diseases No taking any drugs or special physical activity
Exclusion criteria:
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 32
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were divided into 4 groups evenly using Permuted Block Randomization. Then, based on the blocks that were randomly assigned using the random number table, the order of the intervention was determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
Supplements were coded by a third person and given to participants in a same form package. None of the participants and researchers were aware of the allocation of groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Azad University East Tehran Branch
Street address
Bahonar Street, Afsarieh highway
City
Tehran
Province
Tehran
Postal code
۱۸۶۶۱۱۳۱۱۸
Approval date
2018-04-21, 1397/02/01
Ethics committee reference number
IR.IAUETB.61009

Health conditions studied

1

Description of health condition studied
Metabolic Syndrome
ICD-10 code
E90
ICD-10 code description
Nutritional and metabolic disorders in diseases classified elsewhere

Primary outcomes

1

Description
Malondialdehyde serum levels (pg/dl)
Timepoint
Before the intervention and after 8 weeks of aerobic exercise and resveratrol supplementation
Method of measurement
ELISA method

2

Description
Total Anti-oxidant Capacity serum level (pg/dl)
Timepoint
Before the intervention and after 8 weeks of aerobic exercise and resveratrol supplementation
Method of measurement
ELISA method

Secondary outcomes

1

Description
Weight (kg)
Timepoint
Before the intervention and after 8 weeks of aerobic exercise and resveratrol supplementation
Method of measurement
Scales

2

Description
Height (cm)
Timepoint
Before the intervention and after 8 weeks of aerobic exercise and resveratrol supplementation
Method of measurement
Meter strip

3

Description
Body mass index (weigh/height2)
Timepoint
Before the intervention and after 8 weeks of aerobic exercise and resveratrol supplementation
Method of measurement
Calculation based on formula

4

Description
Waist circumference (cm)
Timepoint
Before the intervention and after 8 weeks of aerobic exercise and resveratrol supplementation
Method of measurement
Meter strip

5

Description
Systolic blood pressure (mmhg)
Timepoint
Before the intervention and after 8 weeks of aerobic exercise and resveratrol supplementation
Method of measurement
Manometer

6

Description
Diastolic blood pressure (mmhg)
Timepoint
Before the intervention and after 8 weeks of aerobic exercise and resveratrol supplementation
Method of measurement
Manometer

7

Description
Fasting blood sugar (mg/dl)
Timepoint
Before the intervention and after 8 weeks of aerobic exercise and resveratrol supplementation
Method of measurement
Enzymic

8

Description
Maximum oxygen ventilation (%)
Timepoint
Before the intervention and after 8 weeks of aerobic exercise and resveratrol supplementation
Method of measurement
Bruce test

9

Description
Triglyceride serum level (mg/dl)
Timepoint
Before the intervention and after 8 weeks of aerobic exercise and resveratrol supplementation
Method of measurement
Enzymic

10

Description
Total cholesterol (mg/dl)
Timepoint
Before the intervention and after 8 weeks of aerobic exercise and resveratrol supplementation
Method of measurement
Enzymic

Intervention groups

1

Description
The Intervention group 1: Aerobic training, 3 session per week 60 minutes, fore 8 week
Category
Lifestyle

2

Description
Intervention group 2: Receiving resveratrol supplement 400 mg, in capsule form daily, for 8 week
Category
Prevention

3

Description
Intervention group 3: Receiving aerobic training, 3 session per week 60 minutes + resveratrol capsule 400 mg daily, fore 8 week
Category
Prevention

4

Description
Control group: The capsule contain of starch powder 400 mg, daily, for 8 week
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Mokhaberat club
Full name of responsible person
Shima Hadavi
Street address
No. 252, Hafez Street.
City
Tehran
Province
Tehran
Postal code
1134845767
Phone
+98 21 6670 5172
Email
hadavi.nutrition@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Abdolrasoul Daneshjoo
Street address
No. 4, Third twelve metric Ave., Seoul Street.
City
Tehran
Province
Tehran
Postal code
1134845767
Phone
+98 21 6670 5172
Email
phdanesh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
1
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mina Abdolahi
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Amiralam hospital, Sa'di etreet
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6670 8103
Email
abdolahimina.n@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mina Abdolahi
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Amiralam Hospital, Sa'adi Street.
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6670 8103
Email
abdolahimina.n@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mina Abdolahi
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Amiralam Hospital, Sa'adi Street.
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6670 8103
Email
abdolahimina.n@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
In addition to data on the main outcome of the study (oxidative stress), the baseline data of participants (such as demographic and anthropometric data) will shared after blinding.
When the data will become available and for how long
Start the access 6 months after publishing the results
To whom data/document is available
The results of present study will be available to academic researcher and pharmaceutical companies in order to supplement production.
Under which criteria data/document could be used
The data of present study can be used for review, systematic review and meta-analysis articles.
From where data/document is obtainable
Applicants can access to study results trough e-mail to a scientist responsible for the study: Dr. Mina Abdolahi Email: abdolahimina.n@gmail.com
What processes are involved for a request to access data/document
Through sites which the manuscript will indexed, through research gate site and e-mail to scientist responsible for the study (Dr. Mina Abdolahi)
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