High-Intensity Functional Training Combined with Hibiscus sabdariffa Supplementation Improves Cardiovascular Risk Factors in Overweight and Obese Men: A Randomized Controlled Trial

The aim of this study is to evaluate the combined effects of high-intensity functional training (HIFT) and Hibiscus sabdariffa on reducing cardiovascular risk factors such as blood pressure, lipid profile, and inflammation markers in overweight and obese men aged 20 to 25 years.

This is a randomized, double-blind, parallel clinical trial that evaluates the combined effects of high-intensity functional training (HIFT) and Hibiscus sabdariffa on cardiovascular risk factors in overweight and obese men. Randomization will be performed using a random number table.

This study will be conducted at the Health Research Center of islamic azad university shahrekord branch . All interventions will be performed in a controlled environment with the use of intervention and control groups. Participants will be randomly allocated to different groups, and randomization and blinding will be used to prevent bias.

Men aged 20 to 25 years Body mass index (BMI) between 25 and 35 kg/m² No history of regular physical activity in the past 12 months No medical conditions that prevent participation in intense physical activity

This study includes four groups: the HIFT group, the Hibiscus sabdariffa group, the combined HIFT and Hibiscus sabdariffa group, and the control group. Each group receives a specific intervention.

The primary outcomes of this study include reduction in blood pressure, improvement in lipid profile (LDL, HDL, total cholesterol, and triglycerides), and reduction in inflammation markers (CRP) in each of the intervention groups.

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.

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.

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

Access to the data will be available for a period of 6 months following the publication of the study results

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

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

To request data and documents, please contact the research manager: Name: Akram Jafari Email: Jafari.skm@gmail.com

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.