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HealthyNCT02697903

Pomegranate Improve Biological Recovery Kinetics in Elite Weightlifter

A study testing Natural Pomegranate Juice in people with Healthy, run by The Higher Institute of Sport and Physical Education of Sfax at 1 site in Tunisia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 24 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Natural Pomegranate Juice
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
9 participants
Where
1 siteTunisia
Study dates
Jan 2015to Feb 2015
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 20 to 24 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Tunisia1 site
  • Achraf

    Sfax, 3000

Other trials in Tunisia

About this study

Official title: 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

Read the 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.

Conditions
Healthy
Being tested
Natural Pomegranate Juice, Placebo Juice
Keywords
Creatine kinase supplementation, C-reactive protein, resistance training, Pomegranate supplementation, pomegranate juice, muscle damage response

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Natural Pomegranate JuiceDietary supplement

    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 JuiceDietary supplement

    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

Study groups in NCT02697903
Study groupRoleWhat they receive
9 elite weightliftersExperimentalage: 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.
Receives: Dietary Supplement: Natural Pomegranate Juice
9elite weightliftersPlacebo comparatorage: 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.
Receives: Dietary Supplement: Placebo Juice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in physical performance from using Placebo to using Pomegranate juice

    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)

    Measured: 3min after Placebo and Pomegranate training sessions

  2. Change in Acute Hematological responses from using Placebo to using Pomegranate juice

    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)

    Measured: 3min after Placebo and Pomegranate training sessions

  3. Change in Acute Biochemical responses from using Placebo to using Pomegranate juice

    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

    Measured: 3min after Placebo and Pomegranate training sessions

  4. Change in Delayed Hematological responses from using Placebo to using Pomegranate juice

    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)

    Measured: 48h after Placebo and Pomegranate training sessions

  5. Change in Delayed Biochemical responses from using Placebo to using Pomegranate juice

    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

    Measured: 48h after Placebo and Pomegranate training sessions

Secondary outcomes (7)
  1. Change in the acute fatigue perception (RPE values) from Placebo to Pomegranate supplementation

    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

    Measured: 3min after Placebo and Pomegranate training sessions

  2. Change in the delayed muscle soreness (DOMS values) from Placebo to Pomegranate supplementation

    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.

    Measured: 48 after Placebo and Pomegranate training sessions

  3. Change in the acute oral temperature response from Placebo to Pomegranate supplementation

    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

    Measured: 3min after Placebo and Pomegranate training sessions

  4. Change in the acute Heart rate ( HR) response from Placebo to Pomegranate supplementation

    heart rate (HR) was recorded using a heart rate monitor

    Measured: 3min after Placebo and Pomegranate training sessions

  5. Change in the acute systolic arterial pressure (SAP) response from Placebo to Pomegranate supplementation

    systolic arterial pressure (SAP) was recorded using a manual sphygmomanometer

    Measured: 3min after Placebo and Pomegranate training sessions

  6. Baseline values of body mass

    Measured: at baseline status

  7. baseline values of height

    Measured: at baseline status

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2016 (estimated)
  2. Study startJan 2015
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

Resources

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
Supportive care
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02697903
Sponsor's protocol ID
16-2015
Status last verified
Mar 2016
First submitted
24 Feb 2016
Last updated
3 Mar 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Data will be shared with researchers outside the primary research group for reanalysis purpose.

Publications

  • Ammar A, Trabelsi K, Bailey SJ, Turki M, Bragazzi NL, Boukhris O, El Abed K, Bouaziz M, Ayadi F, Driss T, Souissi N, Chtourou H, Hokelmann A. Effects of natural polyphenol-rich pomegranate juice supplementation on plasma ion and lipid profiles following resistance exercise: a placebo-controlled trial. Nutr Metab (Lond). 2020 Apr 16;17:31. doi: 10.1186/s12986-020-00451-1. eCollection 2020.

    PubMed 32322289
  • Ammar A, MounaTurki, Trabelsi K, Bragazzi NL, Boukhris O, Bouaziz M, Ayadi F, El Abed K, Driss T, Souissi N, Chtourou H, Bailey SJ, Hoekelmann A. Effects of natural polyphenol-rich pomegranate juice on the acute and delayed response of Homocysteine and steroidal hormones following weightlifting exercises: a double-blind, placebo-controlled trial. J Int Soc Sports Nutr. 2020 Mar 6;17(1):15. doi: 10.1186/s12970-020-00345-w.

    PubMed 32143716
  • Ammar A, Turki M, Chtourou H, Hammouda O, Trabelsi K, Kallel C, Abdelkarim O, Hoekelmann A, Bouaziz M, Ayadi F, Driss T, Souissi N. Pomegranate Supplementation Accelerates Recovery of Muscle Damage and Soreness and Inflammatory Markers after a Weightlifting Training Session. PLoS One. 2016 Oct 20;11(10):e0160305. doi: 10.1371/journal.pone.0160305. eCollection 2016.

    PubMed 27764091

Questions about this trial

What is this clinical trial studying?

A study testing Natural Pomegranate Juice in people with Healthy, run by The Higher Institute of Sport and Physical Education of Sfax at 1 site in Tunisia.

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 2 inclusion and 2 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 3 Mar 2016. 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 Tunisia. 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?

Change in physical performance from using Placebo to using Pomegranate juice (time frame: 3min after Placebo and Pomegranate training sessions). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02697903, which also lists 3 linked publications.

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 3 Mar 2016.

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