The combination effects of Beetroots Juice and Caffeine with High-Intensity Interval Training on cardiovascular risk factors in Middle-Aged Obese Men

This study aims to investigate the metabolic profile of middle-aged obese individuals through the incorporation of beetroot juice (BRJ), caffeine, and high-intensity interval training (HIIT).

The clinical trial will have a control group, with parallel groups, double-blind, and a sample size of 80 with a random sequence using the randomizeR package in R software and will be divided into four groups.

All groups perform the HIIT program, which is conducted at the university gym of Halabja, Iraq, under the guidance of an exercise physiologist, utilizing a motorized treadmill. Participants are unaware of which group they are assigned to and whether they are receiving active supplements, placebos, or a combination.

The inclusion criteria comprise men with obesity (BMI ≥30 kg/m²), stable weight, a sedentary lifestyle, no history of cardiovascular or metabolic disorders, and no consumption of nutritional supplements.The exclusion criteria include chronic illnesses, tobacco use, recent nitrate supplementation, or regular caffeine consumption.

Participants are categorized into four groups: (1) placebo, (2) beetroot juice, (3) caffeine, and (4) beetroot juice combined with caffeine.All groups engage in identical high-intensity interval training programs.

Anthropometric (body composition, VO₂ peak), blood analysis (IL-6, TNF-α, CRP, IL-10, NOx, NO, and eNOS, OxLDL, TOS, OSI, and TBARS, troponin I and T, CK-MB and CK-T, lipid profile, glucose, and insulin).

A stratified randomized block design was implemented, considering peak oxygen consumption and body mass index, with two degrees of fitness and body fat %. Randomly interspersed permuted blocks of sizes 4 and 8 were utilized to reduce predictability. Randomization was conducted at the individual level, with each participant independently assigned to one of four groups. Randomization sequences were produced with the randomizeR program within the R software environment. Within each stratum, groups of 4 or 8 allocations were established. Strict confidentiality was kept through the utilization of sealed, opaque, serially numbered envelopes (SNOSE), which were arranged in a sequence tailored to each stratum. Every envelope included a folded allocation card. Following baseline assessments, recruitment personnel accessed the subsequent envelope in the strata relevant to the participant. The envelopes were stored in a secured cabinet accessible just to the trial coordinator.

Participant blinding: Subjects remain uninformed about their group assignment and whether they are getting active supplements, a placebo, or a combination of both. They are aware that the supplements are probably caffeine, beetroot juice, a combination of both, or a placebo. They are also unable to discern their supplement kind from flavor, look, or packaging. Moreover, practitioners engaged in direct engagement with participants (e.g., conducting training sessions, administering supplements, collecting performance data, evaluating results, and analyzing data) remain uninformed about the group type, therefore identifying groups solely by code (Group A, B, C, or D). To preserve blindness, beetroot juice placebos typically consist of nitrate-free beetroot juice or an inert beverage that resembles the color and flavor of beetroot juice. The caffeine and placebo are indistinguishable tablets, frequently opaque. All supplements were made by individuals not participating in the intervention. All participants, irrespective of group affiliation, got two items (a beverage and a pill) every day or prior to exercise.

There is a plan to share the results of this study in a manuscript which may publish finally.

After finishing the intervention and analyzing data, and writing the manuscript the data will be published as the journal allows.

To the reviewers of journals which publishes our manuscript.

There is no restricted condition except the private information regarding the subjects.

The person responsible to this document is Dara Latif Saifalddin which can be available via email address: dara.saifaddin@uoh.edu.iq

Academic person can request the document after publishing the data, and the will get answer as soon as possible.