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

NCT04597983 | Completed

• 1 other identifier: CE091802
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• Maximum power

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

  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)

  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)

  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)

  Throughout study completion, an average of 8 weeks

Secondary Outcomes (39)

• Fat mass

  Throughout study completion, an average of 8 weeks

• Sum of 8 skinfolds

  Throughout study completion, an average of 8 weeks

• Muscle mass

  Throughout study completion, an average of 8 weeks

• Resting metabolic rate

  Throughout study completion, an average of 8 weeks

• Superoxide dismutase (antioxidant marker)

  Superoxide dismutase was measured in pre, after the maximum power phase of the rectangular test and after the recovery phase in pre and post intervention (8 weeks) in both groups.

Study Arms (2)

2S-hesperidin

EXPERIMENTAL

This group took 500 mg (capsules) per day at breakfast of 2S-hesperidin (Cardiose®) for 8 weeks

Dietary Supplement: 2S-hesperidin

Placebo

PLACEBO COMPARATOR

This group took 500 mg of microcellulose (capsules) per day at breakfast for 8 weeks

Dietary Supplement: Placebo

Interventions

2S-hesperidin DIETARY_SUPPLEMENT

Cardiose® is a natural orange extract that due to its unique manufacturing process, maintains most of the natural hesperidin isomeric form (2S)

Also known as: Cardiose®

2S-hesperidin

Placebo DIETARY_SUPPLEMENT

Microcellulose was used, this molecule was selected to avoid affecting the glycemia, as it can occur with dextrose or maltodextrin.

Also known as: Microcellulose

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Francisco Javier Martínez Noguera: lead

Study Sites (1)

Research Center for High Performance Sport. Catholic University of Murcia

La Ñora, Murcia, 30830, Spain

Location

MeSH Terms

Conditions

Body Weight Changes; Fatty Liver; Muscular Atrophy; Hypoxia; Acid-Base Imbalance

Interventions

Hesperidin

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms, Respiratory; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Flavanones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glycosides; Carbohydrates

Study Officials

• Pedro Emilio Alcaraz Ramón

  Catholic University of Murcia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The company that performed the encapsulation of both the 2S-hesperidin and the placebo performed the randomization, therefore no one on the research team or the sponsors knew which group each study subject belonged to. The results of the randomization were sent to our laboratory after the end of the study to determine which subjects composed each group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research study coordinator

Model Details: 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.

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 22, 2020
• Study Start: September 22, 2018
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2018
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)