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IRCT20241205063953N1 IRCT 2025-01-08 Islamic Azad University High-Intensity Functional Training Combined with Hibiscus sabdariffa Supplementation and Cardiovascular Risk Factors High-Intensity Functional Training Combined with Hibiscus sabdariffa Supplementation Improves Cardiovascular Risk Factors in Overweight and Obese Men: A Randomized Controlled Trial 2024-08-20 anticipated 60 Complete https://irct.ir/trial/81061 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Four groups (HIFT, Hibiscus sabdariffa, combined, and control) are evaluated. HIFT sessions and daily Hibiscus sabdariffa supplementation are administered for 12 weeks, Randomization description: In this study, participants are randomly assigned to different groups, with each group receiving a specific intervention (Hibiscus tea, HIFT, or a combination of both). Random allocation will be performed using a random number table to prevent bias in group assignment, Blinding description: In this study, blinding was implemented as follows: Participant allocation to groups was performed by an independent statistician using a computer-generated randomization list, and study groups were assigned unique codes. The supplement and placebo capsules, identical in appearance, size, and color, were manufactured by a pharmaceutical company. The labeling of these capsules was conducted by a person unrelated to the study's execution. Participants were unaware of the capsule contents, and the research team, including coaches and outcome assessors, had no access to group allocation information. These measures ensured that any potential bias in data collection or outcome evaluation was minimized. N/A Cardiovascular risk factors (Obesity, Hypertension, Dyslipidemia). Intervention 1: Intervention group: In this group, participants undergo a high-intensity functional training (HIFT) program for 12 weeks. The program consists of three sessions per week, each lasting 45 minutes. The training includes multi-joint movements such as squats, jumps, and resistance exercises targeting the major muscle groups of the body. Intervention 2: Intervention group: In this group, participants consume 450 mg of Hibiscus sabdariffa daily for 12 weeks. The Hibiscus sabdariffa capsules are made from the dried extract of Hibiscus flowers, with each capsule containing 450 mg of the extract. Intervention 3: Intervention group: In this group, participants receive both the high-intensity functional training (HIFT) program and daily supplementation of 450 mg of Hibiscus sabdariffa for 12 weeks. Yes - There is a plan to make this available What will be shared: Document Title: Anthropometric data, lipid profile, blood pressure, and inflammation markers (CRP) Further Details: Individual participant data will be shared after de-identification. These data include information related to primary outcomes (weight, BMI, lipid profile, blood pressure, and CRP) and will be available as a dataset for further analysis When: Access to the data will be available for a period of 6 months following the publication of the study results To whom: Data and documents will be accessible only to academic and scientific researchers working in the health field. Industry professionals involved in health-related research may also request access to the data Conditions: The data and documents are available for scientific and health-related research purposes. Data access requests must include a clear objective for using the data. Commercial use or use outside the scientific framework is not permitted. Access to the data will be granted only after review and approval of the request Where to obtain: To request data and documents, please contact the research manager: Name: Akram Jafari Email: Jafari.skm@gmail.com How to obtain: Requests for data access should be submitted to the provided email address. After reviewing the request, an approval confirmation will be sent to the requester, and the data will be shared via a secure link or in digital file format. This process typically takes 2 to 4 weeks. Comments:
public Akram Jafari
Rahmatieh- Islamic Azad University Shahrekord Branch
Shahrekord Iran (Islamic Republic of) 8817630003 +98 383361001 jafari.akm@gmail.com Islamic Azad University scientific Akram Jafari
Rahmatieh- Islamic Azad University Shahrekord Branch
Shahrekord Ireland 8817630003 +98 38 3336 1001 jafari.akm@gmail.com Islamic Azad University Iran (Islamic Republic of) Men aged 20-25 years with a body mass index (BMI) between 25 and 35 kg/m² No history of regular physical activity in the past 12 months No medical conditions contraindicating intense physical activity (e.g., heart diseases) Willingness to participate in the study and sign an informed consent form 20 years 25 years Male Individuals allergic to Hibiscus sabdariffa Use of antioxidant drugs or supplements within the past three months E66 Overweight and obesity N/A N/A N/A Intervention group: In this group, participants undergo a high-intensity functional training (HIFT) program for 12 weeks. The program consists of three sessions per week, each lasting 45 minutes. The training includes multi-joint movements such as squats, jumps, and resistance exercises targeting the major muscle groups of the body. Intervention group: In this group, participants consume 450 mg of Hibiscus sabdariffa daily for 12 weeks. The Hibiscus sabdariffa capsules are made from the dried extract of Hibiscus flowers, with each capsule containing 450 mg of the extract. Intervention group: In this group, participants receive both the high-intensity functional training (HIFT) program and daily supplementation of 450 mg of Hibiscus sabdariffa for 12 weeks. Blood pressure. Timepoint: At baseline (pre-intervention) and after 12 weeks (post-intervention). Method of measurement: using a mercury sphygmomanometer. Lipid Profile: total cholesterol, LDL, HDL, and triglycerides. Timepoint: At baseline (pre-intervention) and after 12 weeks (post-intervention). Method of measurement: Blood tests using enzymatic methods for total cholesterol, LDL, HDL, and triglycerides. CRP. Timepoint: At baseline (pre-intervention) and after 12 weeks (post-intervention). Method of measurement: Measured using the ELISA method. Anthropometric Variables: weight, body mass index (BMI), and body fat percentage. Timepoint: At baseline (pre-intervention) and after 12 weeks (post-intervention). Method of measurement: Weight: Measured using a digital scale - BMI: Calculated using the formula weight (kg) divided by height (m) squared - Body Fat Percentage: Measured using a Bioelectrical Impedance Analysis (BIA) device. Islamic Azad University Approved 2022-04-20 Ethics committee of Islamic Azad University Shahrekord branch Rahmatieh- Islamic Azad University Shahrekord Branch Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)