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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02697903
Other study ID # 16-2015
Secondary ID
Status Completed
Phase N/A
First received February 24, 2016
Last updated March 2, 2016
Start date January 2015
Est. completion date February 2015

Study information

Verified date March 2016
Source The Higher Institute of Sport and Physical Education of Sfax
Contact n/a
Is FDA regulated No
Health authority Tunisia: La comité locale du laboratoire biochimie de l'hôpital habib bourguiba
Study type Interventional

Clinical 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. 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 24 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

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 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

Locations

Country Name City State
Tunisia Achraf Sfax

Sponsors (1)

Lead Sponsor Collaborator
The Higher Institute of Sport and Physical Education of Sfax

Country where clinical trial is conducted

Tunisia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 3min after Placebo and Pomegranate training sessions No
Primary 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) 3min after Placebo and Pomegranate training sessions No
Primary 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 3min after Placebo and Pomegranate training sessions No
Primary 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) 48h after Placebo and Pomegranate training sessions No
Primary 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 48h after Placebo and Pomegranate training sessions No
Secondary 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 3min after Placebo and Pomegranate training sessions No
Secondary 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. 48 after Placebo and Pomegranate training sessions No
Secondary 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 3min after Placebo and Pomegranate training sessions No
Secondary Change in the acute Heart rate ( HR) response from Placebo to Pomegranate supplementation heart rate (HR) was recorded using a heart rate monitor 3min after Placebo and Pomegranate training sessions No
Secondary Change in the acute systolic arterial pressure (SAP) response from Placebo to Pomegranate supplementation systolic arterial pressure (SAP) was recorded using a manual sphygmomanometer 3min after Placebo and Pomegranate training sessions No
Secondary Baseline values of body mass at baseline status No
Secondary baseline values of height at baseline status No
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