Clinical trial NCT04597983: Effect of 8-week Intake of 2S-hesperidin on Performance, Body Composition and Biochemicals Markers in Amateur Cyclists
Official title: Effect of 8-week Intake of 2S-hesperidin on Performance, Body Composition and Biochemicals Markers in Amateur Cyclists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Power
Metabolic Disturbance
Change, Body Weight
Changes Fatty
Muscle Loss
Oxidative Stress
Inflammatory Response
Oxygen Deficiency
Acid-Base Imbalance
Electrolyte Disturbance
Keywords: Flavonoids
Polyphenols
Power
Endurance sports
Ergogenic aids
Inflammatory markers
Antioxidant markers
Body Composition
Ventilatory Thresholds
Nutrigenomic
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized parallel study was conducted, where 40 amateur cyclists were divided into 2 groups: one group took 500 mg of 2S-hesperidin (n= 20) and the other group took 500 mg of placebo (microcellulose) (n= 20). All participants completed the study.
Primary purpose: TREATMENT

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

Participants visited the laboratory on seven occasions. Visit 1 consisted of a medical examination and blood extraction to determine health status. On visits 2 and 5, a 24-hr diet recall and a Wingate test were performed. On visits 3 and 6, another 24-hour diet recall was conducted, followed by an incremental test until exhaustion on a cycle ergometer. On visits 4 and 7, the 24-hour diet recall was repeated, and participants performed a rectangular test on the cycle ergometer. Prior to each testing session (visits 2, 3, 4, 5, 6 and 7), a standardized breakfast composed of 95.16 g of carbohydrates (68%), 18.86 g of protein (14%) and 11.30 g of lipids (18%) was prescribed by the sport nutritionist.

Pre and post evaluation test

Pre-intervention visits: 1,2,3 and 4 Post-intervention visits: 5,6 and 7

Visit 1:

Health status blood analysis: A general analysis will be performed both in the pre and post-supplementation period. The extraction will be done by venous via. (Fasting)

Medical examination: A clinical history of family and personal history, a resting electrocardiogram (ECG) and a medical examination (auscultation, blood pressure measurement, etc.) will be taken to certify that the person is healthy and not at risk to participate in the study. (Fasting)

Visits 2 and 5:

Resting Metabolic Rate (RMR): A resting test will be performed with the ergospirometer to determine macronutrient supply at rest and caloric expenditure. (Fasting)

Body composition by absorptiometric densitometry (DXA): A body composition test will be performed by the dual energy absorptiometric densitometry technique (X-ray), with the objective of to determine parameters of fat mass, fat-free mass and fat percentage. In addition, anthropometry was also used to determine changes in body composition (fat and muscle mass). (Fasting)

Anaerobic power and mechanical power production: After a standardized breakfast, a Wingate test was performed on a cycloergometer. Wingate test (WAnT) consisted of an all-out 30-s sprint on a cycloergometer (Monark Ergomedic 894E Peak Bike, Vansbro, Sweden). Breaking resistance was held constant at 7.5% of each individual's body mass. All participants were verbally encouraged to pedal as fast as possible during the entire sprint.

Visits 3 and 6:

Incremental step with final ramp test was performed on a cycle ergometer using a metabolic cart (Metalyzer 3B. Leipzig, Germany) to determine maximal fat oxidation zone (FatMax), ventilatory thresholds 1 (VT1) and 2 (VT2) and maximal oxygen consumption (VO2max). Participants began cycling at 35W for 2 min, increasing then by 35W every 2 min until RER\>1.05, initialling then the final ramp (+35W·min-1) until exhaustion. The estimated functional threshold power (FTP) was calculated using the following equation \[16\]:

FTP (W) = Pmax (W) x 0.865 - 56.484.

Visits 4 and 7:

Rectangular test was performed on a cycle ergometer using the power output values resulting from the maximal test (FatMax, VT1 and VT2). Participants exercised continuously from FatMax, to VT1 and to VT2 for 10 min, without rest. Cardiorespiratory variables (VO2, VO2R, carbohydrate oxidation (CHO), fat oxidation (FAT) and cycling economy) were determined for each metabolic zones.

Urine samples

Main hesperidin metabolites were analysed in participants' urine. Urine samples, corresponding to 24 h urine collection from each participant before and after the supplementation, were frozen in liquid nitrogen after collection and thawed for its analysis.

All the data of the subjects who participated in the study were stored under a computer system with a security key. In addition, a record was also made of some of the paper data that was saved under key, and to which only the researchers of this project had access.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum power
timeFrame: Throughout study completion, an average of 8 weeks
measure: Power generated at FatMax
timeFrame: Throughout study completion, an average of 8 weeks
measure: Power generated at ventilatory threshold 1 (VT1)
timeFrame: Throughout study completion, an average of 8 weeks
measure: Power generated at ventilatory threshold 2 (VT2)
timeFrame: Throughout study completion, an average of 8 weeks
Secondary outcomes:
measure: Fat mass
timeFrame: Throughout study completion, an average of 8 weeks
measure: Sum of 8 skinfolds
timeFrame: Throughout study completion, an average of 8 weeks
measure: Muscle mass
timeFrame: Throughout study completion, an average of 8 weeks
measure: Resting metabolic rate
timeFrame: Throughout study completion, an average of 8 weeks
measure: Superoxide dismutase (antioxidant marker)
timeFrame: 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.
measure: Catalase (antioxidant marker)
timeFrame: 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.
measure: Reduced glutathione (antioxidant marker)
timeFrame: 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.
measure: Oxidized glutathione (antioxidant marker)
timeFrame: 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.
measure: GSSG/GSH ratio (antioxidant marker)
timeFrame: 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.
measure: Hemoxigenase 1 (antioxidant marker)
timeFrame: 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.
measure: Thiobarbituric acid reactive substances (oxidant marker)
timeFrame: 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.
measure: Interleukin 6 (inflammatory marker)
timeFrame: 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.
measure: Tumor necrosis factor (inflammatory marker)
timeFrame: 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.
measure: C-reactive protein (inflammatory marker)
timeFrame: 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.
measure: Monocyte chemoattractant protein-1 (inflammatory marker)
timeFrame: 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.
measure: Hemoglobin (oximetry marker)
timeFrame: 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.)
measure: Hematocrit (oximetry marker)
timeFrame: 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.)
measure: Oxygen saturation (oximetry marker)
timeFrame: 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.)
measure: Oxygen partial pressure (oximetry marker)
timeFrame: 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.)
measure: Carbon dioxide partial pressure (oximetry marker)
timeFrame: 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.)
measure: Oxyhemoglobin (oximetry marker)
timeFrame: 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.)
measure: Carboxyhemoglobin (oximetry marker)
timeFrame: 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.)
measure: Deoxyhemoglobin (oximetry marker)
timeFrame: 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.)
measure: Methemoglobin (oximetry marker)
timeFrame: 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.)
measure: Total blood oxygen concentration (oximetry marker)
timeFrame: 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.)
measure: Total blood carbon dioxide concentration (oximetry marker)
timeFrame: 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.)
measure: Oxygen partial pressure at 50% oxygen saturation (oximetry marker)
timeFrame: 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.)
measure: Relative physiological Shunt (oximetry marker)
timeFrame: 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.)
measure: Alveolar-arterial gradient (oximetry marker)
timeFrame: 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.)
measure: Bicarbonate (metabolic marker)
timeFrame: 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.)
measure: Glucose (metabolic marker)
timeFrame: 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.)
measure: Lactate (metabolic marker)
timeFrame: 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.)
measure: pH (metabolic marker)
timeFrame: 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.)
measure: Actual base excess (metabolic marker)
timeFrame: 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.)
measure: Standard base excess (metabolic marker)
timeFrame: 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.)
measure: Sodium (metabolic marker)
timeFrame: 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.)
measure: Potassium (metabolic marker)
timeFrame: 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.)
measure: Chloride (metabolic marker)
timeFrame: 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.)
measure: Calcium (metabolic marker)
timeFrame: 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.)
Other outcomes:
Locations:
city: La Ñora
country: Spain
facility: Research Center for High Performance Sport. Catholic University of Murcia
state: Murcia
Study officials:
affiliation: Catholic University of Murcia
name: Pedro Emilio Alcaraz Ramón
role: PRINCIPAL_INVESTIGATOR
References: