NCT04597983CompletedNot Applicable

Effect of 8-week Intake of 2S-hesperidin on Performance, Body Composition and Biochemicals Markers in Amateur Cyclists

Francisco Javier Martínez Noguera2 sites in 1 country40 target enrollmentStarted: September 22, 2018Last updated: October 23, 2020

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor
Enrollment: 40
Locations: 2
Primary Endpoint: Maximum power

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

This clinical study evaluates the effect of 500 mg of 2S-hesperidin for 8 weeks on performance (power generated in different metabolic zones), body composition (fat and muscle mass) and biochemical (antioxidant, inflammatory status) and metabolic (capillary blood in finger) markers in amateur cyclists. Our hypothesis is that chronic intake of 2S-hesperidin can improve performance (maximum power generated). To justify this hypothesis, we measured the parameters mentioned above, which could establish a cause-effect relationship between 2S-hesperidin intake and possible yield improvement.

Detailed Description

Participants

All participants were informed about the procedures and provided signed informed consent. The study was conducted according to the guidelines of the Helsinki Declaration for Human Research and the protocol was approved by the Ethics Committee/Institutional Review Catholic University of Murcia (Code: CE091802).

Study design

Cyclists were instructed to take the supplement along with breakfast and to continue their usual diet and training schedule. Subjects in both groups were instructed not to consume foods high in citrus flavonoids (grapefruit, lemons or oranges) for 5 days prior to and during the study, this was verified by diet recalls records.

Procedures

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Triple (Participant, Investigator, Outcomes Assessor)

Masking Description

The company that performed the encapsulation of both the 2S-hesperidin and the placebo performed the randomization, therefore no one on the research team or the sponsors knew which group each study subject belonged to. The results of the randomization were sent to our laboratory after the end of the study to determine which subjects composed each group

Eligibility Criteria

Ages: 18 Years to 55 Years (Adult)
Sex: Male
Accepts Healthy Volunteers: Yes

Inclusion Criteria

•18-55 years,
•BMI of 19-25.5 kg·m-2
•At least 3 years of cycling experience and training for 6-12 h·wk-1

Exclusion Criteria

•Were smokers or regular alcohol drinkers,
•Had a metabolic, cardiorespiratory or digestive pathology or anomaly,
•Had an injury in the prior 6 months
•Were supplementing or medicating in the prior 2 weeks
•Had non-normal values in the blood analysis parameters.

Outcomes

Primary Outcomes

Maximum power

Time Frame: Throughout study completion, an average of 8 weeks

During the incremental test until exhaustion, the power generated was measured maximum power (W)

Power generated at FatMax

Time Frame: Throughout study completion, an average of 8 weeks

During the incremental test until exhaustion, the power generated was measured in FatMax (W)

Power generated at ventilatory threshold 1 (VT1)

Time Frame: Throughout study completion, an average of 8 weeks

During the incremental test until exhaustion, the power generated was measured in VT1 (W)

Power generated at ventilatory threshold 2 (VT2)

Time Frame: Throughout study completion, an average of 8 weeks

During the incremental test until exhaustion, the power generated was measured in VT2 (W)

Secondary Outcomes

Resting metabolic rate(Throughout study completion, an average of 8 weeks)
GSSG/GSH ratio (antioxidant marker)(GSSG/GSH ratio was measured in pre, after the maximum power phase of the rectangular test and after the recovery phase in pre and post intervention (8 weeks) in both groups.)
Hemoxigenase 1 (antioxidant marker)(Hemoxigenase 1 was measured in pre, after the maximum power phase of the rectangular test and after the recovery phase in pre and post intervention (8 weeks) in both groups.)
Thiobarbituric acid reactive substances (oxidant marker)(Thiobarbituric acid reactive substances was measured in pre, after the maximum power phase of the rectangular test and after the recovery phase in pre and post intervention (8 weeks) in both groups.)
Fat mass(Throughout study completion, an average of 8 weeks)
Sum of 8 skinfolds(Throughout study completion, an average of 8 weeks)
Muscle mass(Throughout study completion, an average of 8 weeks)
Superoxide dismutase (antioxidant marker)(Superoxide dismutase was measured in pre, after the maximum power phase of the rectangular test and after the recovery phase in pre and post intervention (8 weeks) in both groups.)
Catalase (antioxidant marker)(Catalase was measured in pre, after the maximum power phase of the rectangular test and after the recovery phase in pre and post intervention (8 weeks) in both groups.)
Reduced glutathione (antioxidant marker)(Reduced glutathione was measured in pre, after the maximum power phase of the rectangular test and after the recovery phase in pre and post intervention (8 weeks) in both groups.)
Oxidized glutathione (antioxidant marker)(Oxidized glutathione was measured in pre, after the maximum power phase of the rectangular test and after the recovery phase in pre and post intervention (8 weeks) in both groups.)
Total blood carbon dioxide concentration (oximetry marker)(Total blood carbon dioxide concentration was analyzed pre, at the end of the FatMax phase, VT1, VT2, maximum power, FatMax2 and after the recovery phase of the rectangular test in pre and post intervention (8 weeks) in both groups.))
Oxygen partial pressure at 50% oxygen saturation (oximetry marker)(Oxygen partial pressure at 50% oxygen saturation was analyzed pre, at the end of the FatMax phase, VT1, VT2, maximum power, FatMax2 and after the recovery phase of the rectangular test in pre and post intervention (8 weeks) in both groups.))
Relative physiological Shunt (oximetry marker)(Relative physiological Shunt was analyzed pre, at the end of the FatMax phase, VT1, VT2, maximum power, FatMax2 and after the recovery phase of the rectangular test in pre and post intervention (8 weeks) in both groups.))
Lactate (metabolic marker)(Lactate was analyzed pre, at the end of the FatMax phase, VT1, VT2, maximum power, FatMax2 and after the recovery phase of the rectangular test in pre and post intervention (8 weeks) in both groups.))
pH (metabolic marker)(pH was analyzed pre, at the end of the FatMax phase, VT1, VT2, maximum power, FatMax2 and after the recovery phase of the rectangular test in pre and post intervention (8 weeks) in both groups.))
Actual base excess (metabolic marker)(Actual base excess was analyzed pre, at the end of the FatMax phase, VT1, VT2, maximum power, FatMax2 and after the recovery phase of the rectangular test in pre and post intervention (8 weeks) in both groups.))
Standard base excess (metabolic marker)(Standard base excess was analyzed pre, at the end of the FatMax phase, VT1, VT2, maximum power, FatMax2 and after the recovery phase of the rectangular test in pre and post intervention (8 weeks) in both groups.))
Sodium (metabolic marker)(Sodium was analyzed pre, at the end of the FatMax phase, VT1, VT2, maximum power, FatMax2 and after the recovery phase of the rectangular test in pre and post intervention (8 weeks) in both groups.))
Potassium (metabolic marker)(Potassium was analyzed pre, at the end of the FatMax phase, VT1, VT2, maximum power, FatMax2 and after the recovery phase of the rectangular test in pre and post intervention (8 weeks) in both groups.))
Chloride (metabolic marker)(Chloride was analyzed pre, at the end of the FatMax phase, VT1, VT2, maximum power, FatMax2 and after the recovery phase of the rectangular test in pre and post intervention (8 weeks) in both groups.))
Calcium (metabolic marker)(Calcium was analyzed pre, at the end of the FatMax phase, VT1, VT2, maximum power, FatMax2 and after the recovery phase of the rectangular test in pre and post intervention (8 weeks) in both groups.))
Interleukin 6 (inflammatory marker)(Interleukin 6 was measured in pre, after the maximum power phase of the rectangular test and after the recovery phase in pre and post intervention (8 weeks) in both groups.)
Tumor necrosis factor (inflammatory marker)(Tumor necrosis factor was measured in pre, after the maximum power phase of the rectangular test and after the recovery phase in pre and post intervention (8 weeks) in both groups.)
C-reactive protein (inflammatory marker)(C-reactive protein was measured in pre, after the maximum power phase of the rectangular test and after the recovery phase in pre and post intervention (8 weeks) in both groups.)
Monocyte chemoattractant protein-1 (inflammatory marker)(Monocyte chemoattractant protein-1 was measured in pre, after the maximum power phase of the rectangular test and after the recovery phase in pre and post intervention (8 weeks) in both groups.)
Hemoglobin (oximetry marker)(Hemoglobin was analyzed pre, at the end of the FatMax phase, VT1, VT2, maximum power, FatMax2 and after the recovery phase of the rectangular test in pre and post intervention (8 weeks) in both groups.))
Alveolar-arterial gradient (oximetry marker)(Alveolar-arterial gradient was analyzed pre, at the end of the FatMax phase, VT1, VT2, maximum power, FatMax2 and after the recovery phase of the rectangular test in pre and post intervention (8 weeks) in both groups.))
Bicarbonate (metabolic marker)(Bicarbonate was analyzed pre, at the end of the FatMax phase, VT1, VT2, maximum power, FatMax2 and after the recovery phase of the rectangular test in pre and post intervention (8 weeks) in both groups.))
Glucose (metabolic marker)(Glucose was analyzed pre, at the end of the FatMax phase, VT1, VT2, maximum power, FatMax2 and after the recovery phase of the rectangular test in pre and post intervention (8 weeks) in both groups.))
Hematocrit (oximetry marker)(Hematocrit was analyzed pre, at the end of the FatMax phase, VT1, VT2, maximum power, FatMax2 and after the recovery phase of the rectangular test in pre and post intervention (8 weeks) in both groups.))
Oxygen saturation (oximetry marker)(Oxygen saturation was analyzed pre, at the end of the FatMax phase, VT1, VT2, maximum power, FatMax2 and after the recovery phase of the rectangular test in pre and post intervention (8 weeks) in both groups.))
Oxygen partial pressure (oximetry marker)(Oxygen partial pressure was analyzed pre, at the end of the FatMax phase, VT1, VT2, maximum power, FatMax2 and after the recovery phase of the rectangular test in pre and post intervention (8 weeks) in both groups.))
Carbon dioxide partial pressure (oximetry marker)(Carbon dioxide partial pressure was analyzed pre, at the end of the FatMax phase, VT1, VT2, maximum power, FatMax2 and after the recovery phase of the rectangular test in pre and post intervention (8 weeks) in both groups.))
Oxyhemoglobin (oximetry marker)(Oxyhemoglobin was analyzed pre, at the end of the FatMax phase, VT1, VT2, maximum power, FatMax2 and after the recovery phase of the rectangular test in pre and post intervention (8 weeks) in both groups.))
Carboxyhemoglobin (oximetry marker)(Carboxyhemoglobin was analyzed pre, at the end of the FatMax phase, VT1, VT2, maximum power, FatMax2 and after the recovery phase of the rectangular test in pre and post intervention (8 weeks) in both groups.))
Deoxyhemoglobin (oximetry marker)(Deoxyhemoglobin was analyzed pre, at the end of the FatMax phase, VT1, VT2, maximum power, FatMax2 and after the recovery phase of the rectangular test in pre and post intervention (8 weeks) in both groups.))
Methemoglobin (oximetry marker)(Methemoglobin was analyzed pre, at the end of the FatMax phase, VT1, VT2, maximum power, FatMax2 and after the recovery phase of the rectangular test in pre and post intervention (8 weeks) in both groups.))
Total blood oxygen concentration (oximetry marker)(Total blood oxygen concentration was analyzed pre, at the end of the FatMax phase, VT1, VT2, maximum power, FatMax2 and after the recovery phase of the rectangular test in pre and post intervention (8 weeks) in both groups.))

Investigators

Sponsor

Francisco Javier Martínez Noguera

Sponsor Class

Other

Responsible Party

Sponsor Investigator

Principal Investigator

Francisco Javier Martínez Noguera

Research study coordinator

Universidad Católica San Antonio de Murcia

Study Sites (2)

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