Pomegranate Improve Biological Recovery Kinetics in Elite Weightlifter

March 2, 2016 updated by: Ammar Achraf, The Higher Institute of Sport and Physical Education of Sfax

Pomegranate Supplementation Accelerates the Recovery Kinetics of Muscle Damage, Muscle Soreness and Inflammatory Marker After Weightlifting Training Session.

From the recent scientific literature in the field of biological response to physical exercise, a significant increase in muscle damage, soreness and inflammation were registered immediately and even 48 after resistance exercise. In the other hand, from the recent scientific literature in the field of nutrition it is well established that Pomegranate juice is a potent antioxidant that can help prevent or treat various disease risk factors. However, only few studies associated the effect of the pomegranate with the physical exercise. To the authors' knowledge, there are no studies investigated the acute and delayed effect of pomegranate supplementation in performance and muscle recovery after exercises involved muscle of whole body. Therefore, the aim of the present study was to investigate the effect of natural Pomegranate juice supplementation on the acute and delayed response of muscle soreness and biochemical parameters following weightlifting training session

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants (i.e., 9 elite weightlifters) performed-as part of their habitual training program from 08h:00 to 09h:45- two training sessions using respectively, PLA and POMj supplementations (500ml), with a recovery period of 48 h in between. Upon arrival for their first test session, each participant's body mass and height were recorded. Moreover, before and after each tested training session, oral temperature was recorded with a calibrated digital clinical thermometer (Omron, Paris, France; accuracy: 0.05°C) inserted sublingually for at least 3 min with the subjects in a seated resting position for at least 15 min. Also, before and after each training session, fasting blood samples (blood sample 2, 3, 4 and 5, Figure1) were collected and heart rate (HR) and systolic arterial pressure (SAP) were recorded using a heart rate monitor and a manual sphygmomanometer. Additionally, to assess the recovery kinetic of the biological parameters, blood sample, temperature, HR and SAP were collected at resting state (i.e., after 10 days of recovery, blood sample 6) and immediately (3min) after the training session which proceed the PLA session (blood sample 1). Given that values of markers of muscle damage remain raised for at least 7 days following intensive weightlifting exercises, a recovery period of 10 days was chosen to evaluate the biological resting state. Additionally, given that (i) using randomized order in this study will results in consuming POMj then PLA supplementations (after 48h) for some participant and (ii) the delayed effect of POMj (which we expect) could alter the results of PLA supplementation, in the present study investigators choose to avoid randomized order and to evaluate the PLA at first then the POMj effect using all the participant together. Supplements (1500ml) of placebo (PLA) or pomegrenate juice (POMj) were taken three times daily in the 48h which proceed the first and the second tested training sessions respectively (i.e. 250ml × 6 times with 8-h intervals between it). Moreover, during these tested sessions, subject consumed an additional 500ml of PLA and 500ml of POMj, respectively. The tested quantity of the natural POMj were prepared from a fresh pomegranate fruit 48h before the beginning of the experimentation and were shipped frozen and stored at -4°C. No additional chemical products were added to the natural POMj. Each 500-mL of the tested POMj contained 2.56g of total polyphenol, 1.08g of ortho-diphenols, 292.59mg of flavonoids and 46.75mg of flavonols. Subjects were reminded verbally through phone communication to consume at the required times their supplements. Placebo juice consisted of an Pomegranate-flavored commercial drink contained water, citric acid, natural flavor and natural identical flavor (Pomegranate), sweeteners (aspartame × (0.3g/l), acesulfame K (0.16g/l)), stabilizers (Arabic gum) and lacked antioxidants, fruit and vegetable extracts or vitamins. Placebo juice contains no polyphenols.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Sfax, Tunisia, 3000
        • Achraf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 24 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • trained at least five sessions per week with 90 to 120 min per session
  • had an experience of more than 3 years in Olympic weightlifting

Exclusion Criteria:

  • use any antioxidant (e.g., vitamin E, A, C etc..) or anti-inflammatory during the experimentation period and one month before
  • had injuries during the experimentation period and one month before

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 9 elite weightlifters
age: 21 ± 0.5 years, body mass: 80 ± 20 kg, height 175 ± 8.1 cm (mean ± SD). They received "Natural Pomegranate Juice" supplementation during and 48h following the first weightlifting training session.
Dietary supplement: Natural Pomegranate Juice
Supplements (1500ml) of pomegrenate juice (POMj) were taken three times daily in the 48h which proceed the first tested training sessions (i.e. 250ml × 6 times with 8-h intervals between it). Moreover, during this tested sessions, subject consumed an additional 500ml of POMj. Arm-specific: Experimental: 9 elite weightlifter
Placebo Comparator: 9elite weightlifters
age: 21 ± 0.5 years, body mass: 80 ± 20 kg, height 175 ± 8.1 cm (mean ± SD). They received "Placebo Juice" supplementation during and 48h following the second weightlifting training session.
Dietary supplement: Placebo Juice
Supplements (1500ml) of Placebo juice (PLA) were taken three times daily in the 48h which proceed the second tested training sessions (i.e. 250ml × 6 times with 8-h intervals between it). Moreover, during this tested sessions, subject consumed an additional 500ml of POMj. Arm-specific: Placebo Comparator: 9 elite weightlifter

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in physical performance from using Placebo to using Pomegranate juice
Time Frame: 3min after Placebo and Pomegranate training sessions
The performance in each session was measured by the total volume lifted in the two Olympic movements (volume lifted (kg) in snatch added volume lifted (kg) in clean and Jerk: only the right lifts are taken into consideration) and by the maximal power lifted amounts in both Olympic movement (i.e., the maximal load lifted (kg) in the power snatch added to the maximal load lifted (kg) in the power clean and Jerk)
3min after Placebo and Pomegranate training sessions
Change in Acute Hematological responses from using Placebo to using Pomegranate juice
Time Frame: 3min after Placebo and Pomegranate training sessions
Haematological parameters (i.e., white blood cells (WBC), neutrophils (NEU), red blood cells (RBC), hemoglobin (HGB), hematocrit (HCT)and platelets (PLT) were generally performed within 3 h of blood sampling in a multichannel automated blood cell analyser Beckman Coulter Gen system-2 (Coulter T540)
3min after Placebo and Pomegranate training sessions
Change in Acute Biochemical responses from using Placebo to using Pomegranate juice
Time Frame: 3min after Placebo and Pomegranate training sessions
Glycemia (GLY), Creatinine (CRE), muscle damage markers (Creatinine kinase (CK), Alkaline phosphate (PAL), Gammaglutamyl (GGT), Lactate dehydrogenase (LDH)) and c-reactive protein (CRP) were determined spectrophotometrically using Abott Architect Ci 4100
3min after Placebo and Pomegranate training sessions
Change in Delayed Hematological responses from using Placebo to using Pomegranate juice
Time Frame: 48h after Placebo and Pomegranate training sessions
Haematological parameters (i.e., white blood cells (WBC), neutrophils (NEU), red blood cells (RBC), hemoglobin (HGB), hematocrit (HCT)and platelets (PLT) were generally performed within 3 h of blood sampling in a multichannel automated blood cell analyser Beckman Coulter Gen system-2 (Coulter T540)
48h after Placebo and Pomegranate training sessions
Change in Delayed Biochemical responses from using Placebo to using Pomegranate juice
Time Frame: 48h after Placebo and Pomegranate training sessions
Glycemia (GLY), Creatinine (CRE), muscle damage markers (Creatinine kinase (CK), Alkaline phosphate (PAL), Gammaglutamyl (GGT), Lactate dehydrogenase (LDH)) and c-reactive protein (CRP) were determined spectrophotometrically using Abott Architect Ci 4100
48h after Placebo and Pomegranate training sessions

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in the acute fatigue perception (RPE values) from Placebo to Pomegranate supplementation
Time Frame: 3min after Placebo and Pomegranate training sessions
The RPE scale (15-points) runs from 6 (very, very light) to 20 (very, very hard) 10. RPE scale measures feelings of effort, strain, discomfort, and/or fatigue experienced during physical task. Although this is a subjective measure (person's exertion), RPE values were shown to provide good estimation of the increase in heart rate, muscle fatigue and several other physiological measures during physical activity
3min after Placebo and Pomegranate training sessions
Change in the delayed muscle soreness (DOMS values) from Placebo to Pomegranate supplementation
Time Frame: 48 after Placebo and Pomegranate training sessions
Delayed onset soreness (DOMS) of the knee extensor and elbow flexor was determined 48 hours after training sessions. 48h after each training session, participants were asked to rate subjectively the degree of soreness in both muscles using a visual analog scale of 0 (absence of soreness) to 10 (unbearable soreness) [28]. Soreness was normalized to 100% of the maximal perceived level.
48 after Placebo and Pomegranate training sessions
Change in the acute oral temperature response from Placebo to Pomegranate supplementation
Time Frame: 3min after Placebo and Pomegranate training sessions
oral temperature was recorded with a calibrated digital clinical thermometer (Omron, Paris, France; accuracy: 0.05°C) inserted sublingually for at least 3 min with the subjects in a seated resting position
3min after Placebo and Pomegranate training sessions
Change in the acute Heart rate ( HR) response from Placebo to Pomegranate supplementation
Time Frame: 3min after Placebo and Pomegranate training sessions
heart rate (HR) was recorded using a heart rate monitor
3min after Placebo and Pomegranate training sessions
Change in the acute systolic arterial pressure (SAP) response from Placebo to Pomegranate supplementation
Time Frame: 3min after Placebo and Pomegranate training sessions
systolic arterial pressure (SAP) was recorded using a manual sphygmomanometer
3min after Placebo and Pomegranate training sessions
Baseline values of body mass
Time Frame: at baseline status
at baseline status
baseline values of height
Time Frame: at baseline status
at baseline status

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Higher Institute of Sport and Physical Education of Sfax

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Achraf Ammar, Dr, Institute of sport and physical education of Sfax, Tunisia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data will be shared with researchers outside the primary research group for reanalysis purpose.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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