Bbackcapclinicalstudy

Consumers of BounceBack™ capsules know they work—and now a recent double-blind, placebo-controlled, crossover pilot study confirms it. As presented at the 2008 International Society of Sports Nutrition Conference and Expo, June 9 -10,2008, Las Vegas, NV, USA

Effect of a combination dietary supplement product (BounceBack™) on the signs and symptoms of delayed onset muscle soreness after eccentric exercise: a randomized, double-blind, placebo-controlled, crossover pilot study Jay Udani , Betsy Singh , Vijay Singh , Elizabeth Sandoval 1 Medicus Research LLC, 18250 Roscoe Blvd. Suite 240, Northridge, CA 91325 2 UCLA/Geffen School of Medicine, Department of Medicine, Los Angeles, CA 12

1

1

1

BACKGROUND Delayed onset muscle soreness (DOMS) is muscle pain and discomfort experienced approximately one to three days after exercise and is believed to be a result of microscopic muscle fiber tears. The product is MeanBounceBack™ VAS Scores Immediately Post-exercise a combination of several dietary supplement ingredients which have individually been shown to improve the inflammation and pain associated with DOMS (digestive enzymes, Bromelain, Curcumin, Vitamin C) in comMyoglobin and CPK Levels With BounceBack™* Mean VAS Scores Immediately Post-exercise of the study was to evaluate the ability of bination with an Avocado Soy extract and Resveratrol.* The purpose the BounceBack™ product to reduce the signs and symptoms of DOMS and increase the rate of muscle recovery following eccentric exercise. 1.2

1.0938

1

0.8

0.8229

Myogl 200

150

100

200 0.6

1.2

0.4

150

1.0938

1

0.3571

0.2

0.8

0.3095

100

0.8229

0

Least Severe Muscle Pain In Past Week, p=0.002

0.6

60

Interference of Pain with Activities, p=0.047

Placebo 0.3571

50

0.3095

50 40 30

BounceBack™

0.4 0.2

60

Baseli (Pre-Exe

*Between group diff

40

PURPOSE AND HYPOTHESIS 0

Least Severe Muscle Pain In Past Week, p=0.002

Interference of Pain with Activities, p=0.047

BounceBack™

Placebo

Visit 3 Visit 4 Hours After (72 (48 hrs) hrs) Eccentric Exercise CPK BounceBack™ Myoglobin BounceBack™

1.2

1.2

1.1146

0.8

0.6905

0.6

Baseline Baseline Baseline Visit 2 Mean VAS Pain Scores(24 athrs)6 (Pre-Exercise) (Post-Exercise) (6 hrs) CPK placebo

*Between group differences were not significant.

This protocol was designed to provide a structured study in which to Mean VAS Pain Scores at 6 Hours After Eccentric evaluate the ability of BounceBack™ to reduce the signs andExercise symptoms of DOMS and increase the rate of muscle recovery following eccentric exercise. Additionally, the total energy expenditure and measured active energy expenditure were tracked during the eccentric exercise and on the days preceding the exercise. 1

30

16

Myoglobin placebo

14

1.1146

1

12 0.8

10

Total VAS Pain Score at 48 Hours After Eccentric Exercise 0.6905

0.6 16

8 6

0.4 14 12 0.2

2

10 0 8

0 Current Severity of Muscle Pain, p=0.039

BounceBack™

Placebo

7.2857

6

0.4

4

13.9821

4

0.2

2

0

0 Current Severity of Muscle Pain, p=0.039

Tot

Mean Total VAS Pain Score, p=0.050

BounceBack™

BounceBack™

Placebo

800

Placebo

700 600

MATERIALS AND METHODS

METs

800

1.2

1.0938

0.8

0.8229

719.6

200

600

100

METs

500

0

459.5

400 300 200

210.86

100 88.31

0 Total Energy Expenditure (p=0.009)

Measured Active Energy Expenditure (p=0.0001)

BounceBack™

Placebo

Myoglobin and CPK Levels With BounceBack™* 200

150

100

0.6 0.4

0.3571

0.2 1.2 0 1

0.3095

Least Severe Muscle Pain In Past Week, 1.0938 p=0.002

Interference of Pain with Activities, p=0.047

60

Myoglobin and CPK Levels With BounceBack™*

50 200 40 150 30

BounceBack™

Placebo

0.8

0.8229

Baseline Baseline (Pre-Exercise) (Post-Exercise)

Baseline (6 hrs)

Visit 2 (24 hrs)

Visit 3 (48 hrs)

CPK BounceBack™ CPK placebo

100

*Between group differences were not significant.

Visit 4 (72 hrs)

Myoglobin BounceBack™ Myoglobin placebo

0.6

60 0.4

0.3571 Mean VAS Pain Scores at0.3095 6 Hours After Eccentric Exercise

0.2 1.2 0

RESULTS

Least Severe Muscle Pain In Past Week, p=0.002 1

Interference of Pain with Activities, 1.1146p=0.047

BounceBack™

Placebo

0.8

50 40

Total VAS Pain Score at 48 Hours After Eccentric Exercise 16

30 14 Baseline Baseline (Pre-Exercise) (Post-Exercise) 12

0.6905

Mean VAS Pain at 6 Hours After Statistically significant differences were observed in favor ofEccentric theScores BounceBack™ Exercise product for pain, tenderness, and amount of energy expended. At 6 hours, the current severity of muscle pain VAS assessments was lower (0.6905 v 1.1146, p=0.039), and at 48 hours, the total VAS pain assessment was significantly lower (7.2857 v 13.9821, p=0.050) in the active group. At 24 hours, the tenderness after algometry was significantly lower (1.7245 v 2.3750, p=0.042) in the active group.* 0.2 1.2

Current Severity of Muscle Pain, 1.1146 p=0.039

BounceBack™

Placebo

0.8

Myoglobin BounceBack™ Myoglobin placebo

2 16 0 14

Mean Total VAS Pain Score, p=0.050

13.9821

12

BounceBack™

Placebo

10 8

7.2857

6

Total Energy Expenditure and Measured Active 4 Energy Expenditure With BounceBack™

0.2

800 2 700 0

0

BounceBack™

719.6

Mean Total VAS Pain Score, p=0.050

600

Placebo METs

BounceBack™

Placebo

500 459.5

400 300

Total 200

Energy Expenditure and Measured Active Energy Expenditure With210.86 BounceBack™

800 100 88.31

7000 600

719.6 Expenditure Total Energy (p=0.009)

Measured Active Energy Expenditure (p=0.0001)

BounceBack™

500 METs

Based on the BodyMedia armband data, the active group recorded significantly greater Total Energy Expenditure (710.60 v 459.50 METs, p=0.009) and Measured Active Energy Expenditure (210.86 v 88.31 METs, p=0.000). Serological markers of muscle damage (CPK and Myoglobin) were lower in the active group throughout the entire postexercise period, but this difference did not reach statistical significance.*

Total VAS Pain Score at 48 Hours After Eccentric Exercise

4

0.4

Current Severity of Muscle Pain, p=0.039

CPK BounceBack™ CPK placebo

Visit 4 (72 hrs)

7.2857

6

0.6905

0.6

Visit 2 Visit 3 13.9821 (48 hrs) (24 hrs)

8

0.4

0 1

Baseline (6 hrs)

*Between10 group differences were not significant.

0.6

400

Placebo 459.5

300 200

210.86

100 88.31

0 Total Energy Expenditure (p=0.009)

CONCLUSIONS

Measured Active Energy Expenditure (p=0.0001)

BounceBack™

Placebo

In this small pilot study, the BounceBack™ product resulted in a significant reduction in standardized measures of pain and tenderness post-eccentric exercise, even after engaging in significantly more activity in the two day period prior to the exercise protocol. The differences in the serological markers of DOMS, while not statistically significant, appear to support the clinical findings.* Further study with a larger sample size is warranted based on the current results. The authors would like to thank Mannatech Incorporated for funding this research.

BIBLIOGRAPHY Volek JS, et al. Am J Physiolo Endocrinol Metab 2002; 282: E474-E482 Beck TW, et al. J Strength Cond Res. 2007; 21(3): 661-667 Davis JM, et al. Am J Physiol Regul Integr Comp Physiol. 2007 Jun; 292 (6):R2168-73 Connolly DA et al. J Sports Med Phys Fitness. 2006 Sep; 46(3): 462-7 Kingsley MI, et al. Med Sci Sports Exerc. 2006 Sep; 38 (9):1617-25 Braun WA, et al. J Sports Med Phys Fitness. 2005 Dec; 45 (4):553-60 Lenn J, et al. Med Sci Spots Exerc. 2002 Oct; 34 (10):1605-13

* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

400 300

700

A randomized, double-blind, placebo-controlled, crossover study was performed with 10 healthy, untrained subjects between the ages of 18 and 45. Subjects were screened for eligibility and then randomized to receive the active or placebo product for 33 days. Subjects wore the BodyMedia Armband Monitoring System during days 28-30 to track their pre-exercise activity level. Subjects returned on day 30 to undergo a standardized eccentric exercise protocol (isokinetic quadriceps squat contractions). Subjects underwent pain and tenderness (algometer) Mean VAS Scores Immediately Post-exercise evaluations and blood draws just prior to exercise, immediately postexercise, and again at 6, 24, 48, and 72 hours post-exercise. Subjects underwent a two week washout, and were then crossed over to the other arm of the study. Mean differences between groups were assessed inferentially at each data collection time-point. Mean VAS Scores Immediately Post-exercise 1

500

Total Energy Expenditure and Measured Active Energy Expenditure With BounceBack™

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