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IRCT20220604055076N1 IRCT 2022-06-13 Islamic Azad University The effect of 8 weeks of functional training and chromium picolinate supplementation on leptin levels and body composition of overweight and obese women The effect of 8 weeks of functional training and chromium picolinate supplementation on leptin levels and body composition of overweight and obese women 2022-07-11 anticipated 40 Complete https://irct.ir/trial/63949 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 40 participants are randomly divided into 4 groups using a table of random numbers. In the present study, the restricted randomization method was used, which will be performed in a block randomization method.The size of four blocks is equal and we will have four groups of 40 blocks (including 10 people participating in each group). Randomization tool also uses software random allocation software (Random allocation software). In addition to simple randomization, these random sequence generation software are able to generate random sequences by block generation method. For concealment, we use concealment allocation, so that the assigned group is not known before the individual is assigned. Using opaque envelopes sealed with random sequences (envelopes opaque, sealed, numbered sequentially), in which each random sequence is recorded on a card. And the cards are placed in the envelopes of the letter, respectively. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed. N/A Condition 1: Serum leptin. Condition 2: Physical composition. Condition 3: Overweight and obesity. Intervention 1: Intervention group1: Daily intake of chromium picolinate supplement (two 200-microgram doses made by 21st Century USA after breakfast and dinner) for eight weeks. Intervention 2: Intervention group2: Perform functional exercises for 8 weeks (including six types of hopping, which will last for eight weeks and three sessions of 31 minutes per week). Intervention 3: Intervention group3: Performing functional exercises and daily consumption of chromium picolinate supplement (two doses of 200 micrograms) for 8 weeks. Intervention 4: Control group:not receiving intervention or treatment to reduce the main consequences. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Given that the report of findings and the result of data analysis will be published in full in the final report and extracted articles. No need to publish data publicly
public Shaghayegh Akramiye
Unit 6, No.16 ,Hamid Alley, North Eskandari St., Azadi St
Tehran Iran (Islamic Republic of) ۱۴۷۷۸۹۳۸۵۵ +98 21 6691 2509 Shaghayegh.painting@yahoo.com Islamic Azad University scientific Shaghayegh Akramiyh
Unit 6, No.16 ,Hamid Alley, North Eskandari St., Azadi St
Tehran Iran (Islamic Republic of) ۱۴۷۷۸۹۳۸۵۵ +98 21 6691 2509 Shaghayegh.painting@yahoo.com Islamic Azad University Iran (Islamic Republic of) Overweight (body mass index 25 to 29.9) Obese (body mass index 30 and more) 25-35 years Female gender 25 years 35 years Female Smoking Participate in regular sports activities for at least the past year Sensitivity to chromium supplementation Prohibition of exercise by a physician E66 Overweight and obesity Treatment - Other Treatment - Other Treatment - Other Treatment - Other Intervention group1: Daily intake of chromium picolinate supplement (two 200-microgram doses made by 21st Century USA after breakfast and dinner) for eight weeks Intervention group2: Perform functional exercises for 8 weeks (including six types of hopping, which will last for eight weeks and three sessions of 31 minutes per week) Intervention group3: Performing functional exercises and daily consumption of chromium picolinate supplement (two doses of 200 micrograms) for 8 weeks Control group:not receiving intervention or treatment to reduce the main consequences Serum leptin levels. Timepoint: One week before the first session (pre-test) and 24 hours after the last training session (post-test) in the eighth week. Method of measurement: ELISA method using Leptin ELISA kit by Mercodia. Physical composition. Timepoint: One week before the first session (pre-test) and 24 hours after the last training session (post-test) in the eighth week. Method of measurement: Bioelectric impedance analysis method by bioelectric impedance device (Model / IOI353). Islamic Azad University Approved 2022-02-20 Ethics Committee of Islamic Azad University, Science and Research Branch Islamic Azad University, Science and Research Branch, shohada Hesarak Boulevard University Square, End of Shahid Sattari Highway, Tehran. Tehran Tehran Iran (Islamic Republic of)