PowerHESPERFORMANNCT04597983
Effect of 8-week Intake of 2S-hesperidin on Performance, Body Composition and Biochemicals Markers in Amateur Cyclists
A study testing 2S-hesperidin in people with Power and Metabolic Disturbance, run by Francisco Javier Martínez Noguera at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Power, Metabolic Disturbance, Change, Body Weight
- What is being tested?
- 2S-hesperidin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 22 Sep 2018to 21 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Research Center for High Performance Sport. Catholic University of Murcia
La Ñora, Murcia, 30830
About this study
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.
Read the 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.
- Conditions
- Power, Metabolic Disturbance, Change, Body Weight, Changes Fatty, Muscle Loss, Oxidative Stress
- Being tested
- 2S-hesperidin, Placebo
- Keywords
- Flavonoids, Polyphenols, Power, Endurance sports, Ergogenic aids, Inflammatory markers, Antioxidant markers, Body Composition, Ventilatory Thresholds, Nutrigenomic
- Medical subject headings
- Body Weight Changes, Fatty Liver, Muscular Atrophy, Hypoxia, Acid-Base Imbalance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2S-hesperidinDietary supplement
Also called Cardiose®
Cardiose® is a natural orange extract that due to its unique manufacturing process, maintains most of the natural hesperidin isomeric form (2S)
PlaceboDietary supplement
Also called Microcellulose
Microcellulose was used, this molecule was selected to avoid affecting the glycemia, as it can occur with dextrose or maltodextrin.
| Study group | Role | What they receive |
|---|---|---|
| 2S-hesperidin | Experimental | This group took 500 mg (capsules) per day at breakfast of 2S-hesperidin (Cardiose®) for 8 weeks Receives: Dietary Supplement: 2S-hesperidin |
| Placebo | Placebo comparator | This group took 500 mg of microcellulose (capsules) per day at breakfast for 8 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum power
During the incremental test until exhaustion, the power generated was measured maximum power (W)
Measured: Throughout study completion, an average of 8 weeks
Power generated at FatMax
During the incremental test until exhaustion, the power generated was measured in FatMax (W)
Measured: Throughout study completion, an average of 8 weeks
Power generated at ventilatory threshold 1 (VT1)
During the incremental test until exhaustion, the power generated was measured in VT1 (W)
Measured: Throughout study completion, an average of 8 weeks
Power generated at ventilatory threshold 2 (VT2)
During the incremental test until exhaustion, the power generated was measured in VT2 (W)
Measured: Throughout study completion, an average of 8 weeks
Secondary outcomes (39)
Fat mass
Fat mass (g) was measured by densitometry and anthropometry.
Measured: Throughout study completion, an average of 8 weeks
Sum of 8 skinfolds
By means of anthropometry, the sum of 8 skinfolds (mm) was calculated.
Measured: Throughout study completion, an average of 8 weeks
Muscle mass
Muscle mass (g) was measured by densitometry and anthropometry
Measured: Throughout study completion, an average of 8 weeks
Resting metabolic rate
Resting metabolic rate was measured by indirect calorimetry.
Measured: Throughout study completion, an average of 8 weeks
Superoxide dismutase (antioxidant marker)
During the rectangular test, superoxide dismutase (U/g Hb) was measured in venous blood.
Measured: 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)
During the rectangular test, catalase (U/g Hb) was measured in venous blood.
Measured: 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)
During the rectangular test, reduced glutathione (GSH) (nmol/mg protein) was measured in venous blood.
Measured: 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)
During the rectangular test, oxidized glutathione (GSSG) (nmol/mg protein) was measured in venous blood.
Measured: 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)
During the rectangular test, GSSG/GSH ratio (%) was measured in venous blood.
Measured: 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)
During the rectangular test, hemoxigenase 1 (ng/mL) was measured in venous blood.
Measured: 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)
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.
Measured: 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)
During the rectangular test, interleukin 6 (pg/ml) was measured in venous blood.
Measured: 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)
During the rectangular test, tumor necrosis (pg/ml) was measured in venous blood.
Measured: 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)
During the rectangular test, C-reactive protein (mg/L) was measured in venous blood.
Measured: 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)
During the rectangular test, monocyte chemoattractant protein-1 (pg/ml) was measured in venous blood.
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start22 Sep 2018
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PowerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Francisco Javier Martínez Noguera
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francisco Javier Martínez Noguera, Universidad Católica San Antonio de Murcia
- Investigators
- Pedro Emilio Alcaraz Ramón, Principal investigator, Catholic University of Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597983
- Sponsor's protocol ID
- CE091802
- Acronym
- HESPERFORMAN
- Status last verified
- Oct 2020
- First submitted
- 30 Sep 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 8-week Intake of 2S-hesperidin on Performance, Body Composition and Biochemicals Markers in Amateur Cyclists
- ClinicalTrials.gov ID
- NCT04597983
- Acronym / sponsor ID
- HESPERFORMAN / CE091802
- Conditions
- Power, Metabolic Disturbance, Change, Body Weight, Changes Fatty, Muscle Loss, Oxidative Stress
- Keywords
- Flavonoids, Polyphenols, Power, Endurance sports, Ergogenic aids, Inflammatory markers, Antioxidant markers, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Francisco Javier Martínez NogueraUniversity, hospital or other
- Study start
- 22 Sep 2018 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 2S-hesperidin | Experimental | Dietary Supplement: 2S-hesperidinThis group took 500 mg (capsules) per day at breakfast of 2S-hesperidin (Cardiose®) for 8 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThis group took 500 mg of microcellulose (capsules) per day at breakfast for 8 weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2S-hesperidinAlso: Cardiose®Cardiose® is a natural orange extract that due to its unique manufacturing process, maintains most of the natural hesperidin isomeric form (2S) | Dietary supplement | 2S-hesperidin |
| PlaceboAlso: MicrocelluloseMicrocellulose was used, this molecule was selected to avoid affecting the glycemia, as it can occur with dextrose or maltodextrin. | Dietary supplement | Placebo |
Primary outcome
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)
39 secondary outcomes
Fat mass
Time frame: Throughout study completion, an average of 8 weeks
Sum of 8 skinfolds
Time frame: Throughout study completion, an average of 8 weeks
Muscle mass
Time frame: Throughout study completion, an average of 8 weeks
Resting metabolic rate
Time frame: 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
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.)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Power
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruitingObservational study
Isokinetic Knee Strength, Bilateral Muscle Balance, and Anaerobic Performance in Adolescent Athletes
Isokinetic Knee Strength, Hamstring-to-Quadriceps Strength Ratio
Active, not recruiting
The Power Down Pilot Study: A Novel Bedtime Manipulation Protocol
Autism, Sleep Disturbance
RecruitingObservational study
Effect of Transpulmonary MP on Prognosis of Patients With Severe ARDS Treated With VV-ECMO
Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Deployment and Clinical Evaluation of an AI-powered Digital Oncology Biomarker Tool to guidE Treatment in TNBC
Triple Negative Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Emilio Alcaraz Ramón principal investigator
Catholic University of Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2S-hesperidin in people with Power and Metabolic Disturbance, run by Francisco Javier Martínez Noguera at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum power (time frame: Throughout study completion, an average of 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.