- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04597983
Effect of 8-week Intake of 2S-hesperidin on Performance, Body Composition and Biochemicals Markers in Amateur Cyclists (HESPERFORMAN)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Murcia
-
La Ñora, Murcia, Spain, 30830
- Research Center for High Performance Sport. Catholic University of Murcia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 2S-hesperidin
This group took 500 mg (capsules) per day at breakfast of 2S-hesperidin (Cardiose®) for 8 weeks
|
Cardiose® is a natural orange extract that due to its unique manufacturing process, maintains most of the natural hesperidin isomeric form (2S)
Other Names:
|
Placebo Comparator: Placebo
This group took 500 mg of microcellulose (capsules) per day at breakfast for 8 weeks
|
Microcellulose was used, this molecule was selected to avoid affecting the glycemia, as it can occur with dextrose or maltodextrin.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Throughout study completion, an average of 8 weeks
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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)
|
Throughout study completion, an average of 8 weeks
|
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)
|
Throughout study completion, an average of 8 weeks
|
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)
|
Throughout study completion, an average of 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fat mass
Time Frame: Throughout study completion, an average of 8 weeks
|
Fat mass (g) was measured by densitometry and anthropometry.
|
Throughout study completion, an average of 8 weeks
|
Sum of 8 skinfolds
Time Frame: Throughout study completion, an average of 8 weeks
|
By means of anthropometry, the sum of 8 skinfolds (mm) was calculated.
|
Throughout study completion, an average of 8 weeks
|
Muscle mass
Time Frame: Throughout study completion, an average of 8 weeks
|
Muscle mass (g) was measured by densitometry and anthropometry
|
Throughout study completion, an average of 8 weeks
|
Resting metabolic rate
Time Frame: Throughout study completion, an average of 8 weeks
|
Resting metabolic rate was measured by indirect calorimetry.
|
Throughout study completion, an average of 8 weeks
|
Superoxide dismutase (antioxidant marker)
Time Frame: 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.
|
During the rectangular test, superoxide dismutase (U/g Hb) was measured in venous blood.
|
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)
Time Frame: 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.
|
During the rectangular test, catalase (U/g Hb) was measured in venous blood.
|
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)
Time Frame: 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.
|
During the rectangular test, reduced glutathione (GSH) (nmol/mg protein) was measured in venous blood.
|
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)
Time Frame: 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.
|
During the rectangular test, oxidized glutathione (GSSG) (nmol/mg protein) was measured in venous blood.
|
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.
|
GSSG/GSH ratio (antioxidant marker)
Time Frame: 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.
|
During the rectangular test, GSSG/GSH ratio (%) was measured in venous blood.
|
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)
Time Frame: 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.
|
During the rectangular test, hemoxigenase 1 (ng/mL) was measured in venous blood.
|
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)
Time Frame: 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.
|
During the rectangular test, thiobarbituric acid reactive substances (TBARS) (mcm/L) ( are formed as a byproduct of lipid peroxidation) was measured to determine the oxidative state in venous blood.
|
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.
|
Interleukin 6 (inflammatory marker)
Time Frame: 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.
|
During the rectangular test, interleukin 6 (pg/ml) was measured in venous blood.
|
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)
Time Frame: 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.
|
During the rectangular test, tumor necrosis (pg/ml) was measured in venous blood.
|
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)
Time Frame: 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.
|
During the rectangular test, C-reactive protein (mg/L) was measured in venous blood.
|
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.
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Monocyte chemoattractant protein-1 (inflammatory marker)
Time Frame: 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.
|
During the rectangular test, monocyte chemoattractant protein-1 (pg/ml) was measured in venous blood.
|
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)
Time Frame: 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.)
|
During the rectangular test, hemoglobin (g/dL) was measured using capillary blood obtained from a finger prick and analyzed in a blood gas analyzer (ABL90 FLEX PLUS, Radiometer Iberica, Spain)
|
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.)
|
Hematocrit (oximetry marker)
Time Frame: 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.)
|
During the rectangular test, hematocrit (%) was measured using capillary blood obtained from a finger prick and analyzed in a blood gas analyzer (ABL90 FLEX PLUS, Radiometer Iberica, Spain)
|
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)
Time Frame: 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.)
|
During the rectangular test, oxygen saturation (%) was measured using capillary blood obtained from a finger prick and analyzed in a blood gas analyzer (ABL90 FLEX PLUS, Radiometer Iberica, Spain)
|
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)
Time Frame: 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.)
|
During the rectangular test, oxygen partial pressure (mmHg) was measured using capillary blood obtained from a finger prick and analyzed in a blood gas analyzer (ABL90 FLEX PLUS, Radiometer Iberica, Spain)
|
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)
Time Frame: 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.)
|
During the rectangular test, carbon dioxide partial pressure (mmHg) was measured using capillary blood obtained from a finger prick and analyzed in a blood gas analyzer (ABL90 FLEX PLUS, Radiometer Iberica, Spain)
|
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)
Time Frame: 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.)
|
During the rectangular test, oxyhemoglobin (%) was measured using capillary blood obtained from a finger prick and analyzed in a blood gas analyzer (ABL90 FLEX PLUS, Radiometer Iberica, Spain)
|
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)
Time Frame: 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.)
|
During the rectangular test, carboxyhemoglobin (%) was measured using capillary blood obtained from a finger prick and analyzed in a blood gas analyzer (ABL90 FLEX PLUS, Radiometer Iberica, Spain)
|
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)
Time Frame: 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.)
|
During the rectangular test, deoxyhemoglobin (%) was measured using capillary blood obtained from a finger prick and analyzed in a blood gas analyzer (ABL90 FLEX PLUS, Radiometer Iberica, Spain)
|
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)
Time Frame: 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.)
|
During the rectangular test, methemoglobin (%) was measured using capillary blood obtained from a finger prick and analyzed in a blood gas analyzer (ABL90 FLEX PLUS, Radiometer Iberica, Spain)
|
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)
Time Frame: 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.)
|
During the rectangular test, total blood oxygen concentration (mmol/L) was measured using capillary blood obtained from a finger prick and analyzed in a blood gas analyzer (ABL90 FLEX PLUS, Radiometer Iberica, Spain)
|
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.)
|
Total blood carbon dioxide concentration (oximetry marker)
Time Frame: 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.)
|
During the rectangular test, total blood carbon dioxide concentration (mmol/L) was measured using capillary blood obtained from a finger prick and analyzed in a blood gas analyzer (ABL90 FLEX PLUS, Radiometer Iberica, Spain)
|
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)
Time Frame: 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.)
|
During the rectangular test, oxygen partial pressure at 50% oxygen saturation (mmHg) was measured using capillary blood obtained from a finger prick and analyzed in a blood gas analyzer (ABL90 FLEX PLUS, Radiometer Iberica, Spain)
|
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)
Time Frame: 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.)
|
During the rectangular test, relative physiological Shunt (%) was measured using capillary blood obtained from a finger prick and analyzed in a blood gas analyzer (ABL90 FLEX PLUS, Radiometer Iberica, Spain)
|
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.)
|
Alveolar-arterial gradient (oximetry marker)
Time Frame: 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.)
|
During the rectangular test, alveolar-arterial gradient (mmHg) was measured using capillary blood obtained from a finger prick and analyzed in a blood gas analyzer (ABL90 FLEX PLUS, Radiometer Iberica, Spain)
|
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)
Time Frame: 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.)
|
During the rectangular test, bicarbonate (mmol/L) wasa measured using capillary blood obtained from a finger prick and analyzed in a blood gas analyzer (ABL90 FLEX PLUS, Radiometer Iberica, Spain)
|
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)
Time Frame: 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.)
|
During the rectangular test, glucose (mg/dL) was measured using capillary blood obtained from a finger prick and analyzed in a blood gas analyzer (ABL90 FLEX PLUS, Radiometer Iberica, Spain)
|
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.)
|
Lactate (metabolic marker)
Time Frame: 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.)
|
During the rectangular test, lactate (mmol/L) was measured using capillary blood obtained from a finger prick and analyzed in a blood gas analyzer (ABL90 FLEX PLUS, Radiometer Iberica, Spain)
|
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)
Time Frame: 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.)
|
During the rectangular test, pH was measured using capillary blood obtained from a finger prick and analyzed in a blood gas analyzer (ABL90 FLEX PLUS, Radiometer Iberica, Spain)
|
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)
Time Frame: 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.)
|
During the rectangular test, actual base excess (mmol/L) was measured using capillary blood obtained from a finger prick and analyzed in a blood gas analyzer (ABL90 FLEX PLUS, Radiometer Iberica, Spain)
|
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)
Time Frame: 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.)
|
During the rectangular test, standard base excess (mmol/L) was measured using capillary blood obtained from a finger prick and analyzed in a blood gas analyzer (ABL90 FLEX PLUS, Radiometer Iberica, Spain)
|
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)
Time Frame: 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.)
|
During the rectangular test, sodium (mmol/L) was measured using capillary blood obtained from a finger prick and analyzed in a blood gas analyzer (ABL90 FLEX PLUS, Radiometer Iberica, Spain)
|
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)
Time Frame: 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.)
|
During the rectangular test, potassium (mmol/L) was measured using capillary blood obtained from a finger prick and analyzed in a blood gas analyzer (ABL90 FLEX PLUS, Radiometer Iberica, Spain)
|
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)
Time Frame: 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.)
|
During the rectangular test, chloride (mmol/L) was measured using capillary blood obtained from a finger prick and analyzed in a blood gas analyzer (ABL90 FLEX PLUS, Radiometer Iberica, Spain)
|
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)
Time Frame: 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.)
|
During the rectangular test, calcium (mmol/L) was measured using capillary blood obtained from a finger prick and analyzed in a blood gas analyzer (ABL90 FLEX PLUS, Radiometer Iberica, Spain)
|
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.)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Pedro Emilio Alcaraz Ramón, Catholic University of Murcia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE091802
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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Utah State UniversityDuke University; United States Department of Agriculture (USDA)Recruiting
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Galvani BioelectronicsNAMSACompleted
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NYU Langone HealthTerminatedInflammatory ResponseUnited States
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Otto Wagner HospitalCompletedInflammatory ResponseAustria
Clinical Trials on 2S-hesperidin
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Technological Centre of Nutrition and Health, SpainUniversity Rovira i Virgili; Hospital Universitari Sant Joan de Reus; Fundació...CompletedBiological AvailabilitySpain
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University of Rome Tor VergataUnknownMetabolic Syndrome | Endothelial DysfunctionItaly
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Purdue UniversityNestec Ltd.CompletedOsteoporosis, PostmenopausalUnited States
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National Nutrition and Food Technology InstituteUnknownMetabolic SyndromeIran, Islamic Republic of
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National Nutrition and Food Technology InstituteUnknownNon Alcoholic SteatohepatitisIran, Islamic Republic of
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National Nutrition and Food Technology InstituteUnknown
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Laboratorios Andromaco S.A.Completed
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Laboratório Teuto Brasileiro S/AUnknownDisease | Chronic Venous Insufficiency
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Montreal Heart InstituteIngenew Pharmaceuticals Inc.CompletedPain | Confusion | Covid19 | Nausea | Vomiting | Cough | Muscle Weakness | Fever | Headache | Anosmia | Sore Throat | Shortness of Breath | Pain, Joint | Pain, Chest | Irritable Mood | Pain, Abdominal | Pain, MuscleCanada
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University of KielHochschule Geisenheim UniversityCompletedHealthy | Higher Uric Acid Concentrations (>5,5 mg/dl)Germany