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IRCT20140415017288N9 IRCT 2023-02-03 Islamic Azad University Effect of Exercise and Salvia officinalis on Postmenopausal Women Preventive effects of Exercise Training and Salvia officinalis on Inflammation and Insulin Resistance in Postmenopausal Women 2023-01-05 anticipated 32 Complete https://irct.ir/trial/67473 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this research, subjects are selected by Simple randomization by the random allocation rule. After determining the sample size (32 people), numbers 1 to 4 are written on 32 small separate papers (8 sheets of paper for each number) and placed in a container. Number 1 is for the Placebo Control group (C), number 2 is for the Aerobic Training Group (AT), number 3 is for the Salvia Officinalis group (So) and number 4 is for the Training-Salvia Officinalis (ATSo). Then each sheet of paper is randomly taken out by the subjects and placed in the intervention or placebo groups, respectively, Blinding description: All the study groups received the supplement in sealed packages that were coded. Coding is done by the researcher and the subjects do not know about it. The Salvia officinalis (So) and Training-Salvia Officinalis (ATSo) receive three 100 mg tablets of So for eight weeks. Placebo Control (C), and Aerobic Training (AT) groups receive a placebo in the same pharmacological presentation. Starch is used as a placebo. 3 Condition 1: Postmenopausal Women. Condition 2: Insulin resistance. Intervention 1: Control group: This group received three 100 mg starch tablets as a placebo during the 8-week intervention period. Intervention 2: Intervention group 1: Training group (in this group for eight-week, three session/weeks, the training start with 10 min warming and then 25 to 45 min training with 40% Maximum heart rate reserve, which in the final weeks reaches 80% of the Maximum heart rate reserve. Also, this group received three 100 mg starch tablets as a placebo during the 8-week intervention period). Intervention 3: Intervention group 2: Intervention group: Salvia officinalis supplement group (this group receives three tablets of 100 mg of So orally daily). Intervention 4: Intervention group 3: Training+ Salvia officinalis supplementation group (In this group the Simultaneous intervention, training, and Salvia officinalis supplementation, will treat with the same protocol describes in the previous part). Yes - There is a plan to make this available What will be shared: Information on the main outcomes will be shared. When: Since 2023 To whom: All researchers Conditions: If people email the person responsible for the plan, they can get the desired documents in the form of a file. Where to obtain: People can apply for documents through email. How to obtain: Maximum one week Comments:
public Ahmad Abdi
Old Amol-Babol road, Kamdereh village- Ayatollah Amoli Branch, Islamic Azad University
Amol Iran (Islamic Republic of) 678 +98 11 4321 7124 a.abdi@iauamol.ac.ir Islamic Azad University scientific Alireza Barari
Old Amol-Babol road, Kamdereh village- Ayatollah Amoli Branch, Islamic Azad University
Amol Iran (Islamic Republic of) 678 +98 11 4321 7126 alireza54.barari@gmail.com Islamic Azad University Iran (Islamic Republic of) being menopausal Age range 50-65 years Inactive lifestyle (exercise less than 1 hour per week) Not taking medicine in the last 6 months. Being willing to participate in the study. 50 years 65 years Female Supplement use. Diagnosis of other diseases during the implementation of the protocol. Not taking Salvia officinalis. Use of estrogen and other androgens and steroids that affect estrogen receptors. Z79.890 R73.02 Postmenopausal Impaired glucose tolerance (oral) Placebo Treatment - Other Treatment - Other Treatment - Other Control group: This group received three 100 mg starch tablets as a placebo during the 8-week intervention period. Intervention group 1: Training group (in this group for eight-week, three session/weeks, the training start with 10 min warming and then 25 to 45 min training with 40% Maximum heart rate reserve, which in the final weeks reaches 80% of the Maximum heart rate reserve. Also, this group received three 100 mg starch tablets as a placebo during the 8-week intervention period). Intervention group 2: Intervention group: Salvia officinalis supplement group (this group receives three tablets of 100 mg of So orally daily). Intervention group 3: Training+ Salvia officinalis supplementation group (In this group the Simultaneous intervention, training, and Salvia officinalis supplementation, will treat with the same protocol describes in the previous part). Tumor Necrosis Factor Alpha. Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods (by ELISA method). Interleukin-10. Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods (by ELISA method). Interleukin-12. Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods (by ELISA method). Fasting blood glucose. Timepoint: Before and after the protocol. Method of measurement: Biochemical methods. Fasting blood insulin. Timepoint: Before and after the protocol. Method of measurement: Biochemical and laboratory methods (by ELISA method). Insulin resistance index (HOMA-IR). Timepoint: Before and after the protocol. Method of measurement: formulas. Islamic Azad University Approved 2022-11-26 Ethics Committee of Islamic Azad University - Marvdasht Branch 3 km of Marvdasht-Persepolis Boulevard, Islamic Azad University, Marvdasht Branch Marvdasht Fars Iran (Islamic Republic of)