IRCT20250531066002N1 IRCT 2025-09-28 The university of Halabja Effects of exercise training and dietary supplements (beetroot juice and caffeine) on cardiovascular risk factors in obese men The combination effects of Beetroots Juice and Caffeine with High-Intensity Interval Training on cardiovascular risk factors in Middle-Aged Obese Men 2025-10-23 anticipated 72 Complete https://irct.ir/trial/84264 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: 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, Blinding description: 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. 0 (exploratory trials) Obesity. Intervention 1: Intervention group 1: beetroot juice: a daily dosage of 70 mL of concentrated beetroot juice (Beet-It Sport Shot 400; James White Ltd, Ashbocking, UK), which contains 400 mg (6.4 mmol) of NO₃⁻ and capsules containing maltodextrin comparable to caffeine capsules. In addition, they perform high-intensity interval training (on a motorized treadmill for 4 × 4-minute intervals at 70-90% of maximum heart rate (HRmax), interspersed with 3 minutes of active recovery) 3 times a week. Intervention 2: Intervention group 2: Caffeine, at a dosage of 6 mg/kg of body weight daily, using pharmaceutical-grade capsules, and a beverage consisting of 1 g of powdered beetroot juice mixed with 1 L of mineral water and lemon juice, akin to the beetroot juice bottle. In addition, they perform high-intensity interval training (on a motorized treadmill for 4 × 4-minute intervals at 70-90% of maximum heart rate (HRmax), interspersed with 3 minutes of active recovery) 3 times a week. Intervention 3: Intervention group 3: caffeine plus beetroot juice; caffeine, a dosage of 6 mg/kg of body weight daily, using pharmaceutical-grade capsules. Moreover, a daily dosage of 70 mL of concentrated beetroot juice (Beet-It Sport Shot 400; James White Ltd, Ashbocking, UK), which contains 400 mg (6.4 mmol) of NO₃⁻, and a placebo capsule similar to a caffeine-containing capsule. In addition, they perform high-intensity interval training (on a motorized treadmill for 4 × 4-minute intervals at 70-90% of maximum heart rate (HRmax), interspersed with 3 minutes of active recovery) 3 times a week. Intervention 4: Intervention group 4: (control-placebo); the placebo group will administer capsules containing maltodextrin comparable to caffeine capsules, along with a beverage consisting of 1 g of powdered beetroot juice mixed with 1 L of mineral water and lemon juice, akin to the beetroot juice bottle, at a specific time. 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 There is no further information