ATP-Pro®
(U.S. formulation)
Clinical Summeries
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Summary 1
Ribose Improves Myocardial Function in Congestive Heart Failure
Study Design: Double blind cross over, 3 weeks/arm with 1 wk washout
Test Substances & Dose: D-ribose, dextrose (placebo) 5 grams /dose t.i.d.
Subjects: 15 adult patients with unstable coronary artery disease & CHF (12 reported)
Results: ECHO revealed a significant improvement in deceleration time of the E wave, stroke volume index , ejection fraction, atrial contribution and LV systolic volume.
Summary 2
D-Ribose Maintains Ejection Fraction Following Aortic Valve Surgery
Study Design: Double blind, post-surgical
Test Substances & Dose: 80mM D-ribose in D 5W or D5W alone (placebo); IV; 5 days
Subjects: 20 adult patients with ejection fraction (EF) a t least 35%; 10 in each group
Results: Eighty percent of the pla cebo patients demonstrated a decline at postoperative day 7 in EF of greater than 15% (range 15 – 56%) from baseline. Twenty percent (20%) of the D-ribose treated patients had a decline in EF at day 7 greater than 15%. No significant changes between either group or within each group was noted in altered myocardial chamber dimensions or hemodynamic parameters. This study suggests that the supplementation of D-ribose ma y prevent deterioration of left ventricular f unction peri-operatively in patients undergoing aortic valve surgery alone or in combination with coronary artery bypass graft.
Source: S, et al. University of Bonn, Bonn, Germany
For presentation to FASEB April 2001
Data on file, Eniva Corp.
Summary 3
Effect of D-Ribose on the Detection of the Hibernatin Myocardium During Low Dose Dobutamine Stress Echocardiography
Study Design: 2 Day randomized, double blind cross over
Test Substance & Dose: Dextrose (pla cebo); Dribose. 4 hour infusion of test substance on first day with cross over on second day to a lternate test substance.
Subjects: 25 patients with ischemic cardiomyopathy (mean EF=30±8%). 11 subjects underwent CABG following the test with follow up echo obtained 1 to 3months post-CABG.
Results: During DE wall motion improved in more dysfunctional segm ents on D-ribose compared to placebo (63 v 45, p=0.02). I n patients undergoing CA BG the sensitivity of DE+D-ribose for prediction of functional recovery w as 61% compared to 46% for DE+placebo (p=0.07). There was a positive relationship between changes in EF during DE+D-ribose infusion and changes in EF after CABG (r=0.47. EF changes during DE+placebo infusion correlated negati vely (r=-.47). D-ribose increased the frequency of response to DE in hibernating regions with contractile dys function. The improvement in global systolic function with DE+D-ribose predicted the magnitude of improvement achieved with revascularization.
Source: Sawada, S, I Pizlo.
Indiana University School of Medicine
Indianapolis, Indiana
Circulation 100(18):3394, 1999
Data on file, Eniva Corp.
Partial completion of Phase II clinical trial.
Summary 4
Effects of Ribose Supplementation on Adenine Nucleotide Concentration in Skeletal Muscle Following High-Intensity Exercise
Study Design: 11-day double blind, placebo controlled trial including three days of pre-test supplem entation, 5 days of high-intensity exercise (2 bouts/day) and 65 hours of rest. Muscle biopsies obtained pre-supplementation, pre-exercise, post-exercise and following rest.
Test Substance & Dose: Dextrose (pla cebo); D-ribose 10-gm dose b.i.d. (20-gm/day)
Subjects: 16 healthy male volunteers
Results: Ribose supplementation attenuated decrease in total adenine nucleotides (TAN) observed during exer cise (p<0.05). Following rest, ribose subject TA N levels returned to baseline, while placebo subjects remained depressed 23% (p<0.05). Ribosemaybe beneficial in the short-term replenishment of TAN immediately following a high-intensity exercise bout.
Source: Gallagher , PM, et al. Ball State University
Muncie, Indiana
Presented at ACSM , October 2000
Data on file, Eniva Corp.
Summary 5
Purine Salvage is Not Reduced During Recovery Following Intense Contractions
Study Design: Salvage of 2.0 mM [3H]-adenine to ATP wa s compared in the presence or absence of 5 mM ribose during cell-f ree perfusion with Krebs-Henseleit buffer in an isolated rat hindlimb preparation (n=5/group) following intense contraction and 1 hour rest.
Results: Return of [ATP] w as incomplete, as the reamination of IMP to A MP/ATP was only 75 - 80% complete. Adenine salvage rates in resting and recovering muscle were relatively low, but increased approximately 5-fold in the presence of ribose.
Conclusion: The high rate of adenine salvage with ribose could be important in ATP recovery of intense contractions, especially if IMP were further degraded to inosine and subsequently lost from the cell.
Source: Zarzeczny, R, et al. University of Missouri
Columbia, Missouri Medicine & Science in Sports & Exercise, 32(5):Supplement, May 2000.
Data on file, Eniva Corp.
Summary 6
Effects of Ribose Supplementation on Performance During Repeated High-Intensity Cycle Sprints
Study Design: 11-day double blind, placebo controlled trial including three days of pre-test supplem entation, 5 days of high-intensity exercise (2 bouts/day) and 65 hours of rest. Exercise bouts consisted of 10 sessions consisting of 15 X 10 second sprints a t 7% body weight. Power output and fatigue were meas ured.
Test Substance & Dose: Dextrose (placebo); D-ribose 10-gm dose b.i.d. (20-gm/day)
Subjects: 16 healthy male volunteers
Results: The ribose group had a greater change in mean power output during the training period than the placebo group (4.2% v 0.6%) and a greater change in peak power output between the las t sprint ses sion than the first (a mea sure of training effect; p<0.05). There was no statistically significant difference in fatigue index. The data suggest that ribose supplementation may provide an ergogenic benefit over time with high-intensity exercise.
Source: Gallagher, PM, et al. Ball State Universi
Muncie, Indiana
Presented at ACSM , October 2000
Data on file, Eniva Corp.
Summary 7
The Effects of Creatine vs Creatine plus D-Ribose Supplementation on Anaerobic Working Capacity after Two Days of Loading
Study Design: Placebo controlled,
double blind
Test substances & Dose: Dextrose
(placebo), creatine, D-ribose,
creatine + D-ribose; 5 gm/dose q.i.d.
Subjects: 38 healthy men & women
(10/group; 8 ribose al one)
Source: Stout, J . Creighton University, Omaha, Nebraska
Data on file, Eniva Corp.
Summary 8
The Effect of D-Ribose on Immune Function
Study Design: HL-60 cells, induced to differentiate with retinoic acid, were incubate with no ribose or with ribose in concentrations of 1.0 to 50.0 mm.
Respiratory burst was determined following 4 days of incubation.
Results: As the concentration of ribose in the differentia ting cultures increased, the respiratory burst increased significantly. Cultures containing 5 and 10 mm /L ribose had significantly greater production of superoxide anion than control. Cultures with 25 and 50 mm /L ribose w ere no longer viable. Cells incubated with 10 mm/L glucose did not have an increase in respiratory burst.
Conclusion: An increased respiratory burst suggests that the population is more differentiate when incubated with ribose than without. (Manuscript in preparation.)
Source: Percival , S. University of Florida
Gainseville, Florida
Presented at FAS EB, April 2000
Data on file, Eniva Corp.
Summary 9
Ribose Supplementation Improves Muscular Strength and Endurance in Male Bodybuilders
Study Design: Double blind placebo controlled, 4 weeks on test substance
Test Substances & Dose: D-ribose, dextrose (placebo) 5 grams /dose b.i.d.
Subjects: 20 young, healthy male bodybuilders
Results: Ribose supplementation resulted in a significant increase in the num ber of total
repetitions performed for 10 sets in the bench press as well as an increase in maximal
strength.
Source: Anton io, J., et al. Universi ty of Delaware, Newark, DE
For presentation to FASEB April 2001
Data on file, Eniva Corp.
Summary 10
Effects of Ingested Ribose on Blood Glucose, Blood Lact and Estimated Rate of Carbohydrate Oxidation
Study Design: Blinded counterbalanced design following 12-hour fast
Test Substances & Dose: Dextrose (placebo; 0 gm), 2, 5 and 10 gm D-ribose in 300 ml water
Subjects: 6 non-diabetic subjects 24-30 years of age
Results: 1) No significant dif ference seen for lactic acid between treatments. 2) A significant difference was seen for blood glucose between groups, with no difference between the 0- and 2-gm dose or the 2- and 5-gm dose. 3) as trong trend (p=0.07) for oxidation rates to be greater with 5- and 10-gm than with 0 and 2-gm . 10-gm 5-gm 2-gm
Source: Fenstad, ER, St. Cloud State University, St. Cloud, M N
Medicine & Science in Sports & Exercise 32(5):Supplement, 2000
Data on file, Eniva Corp.
Summary 11
The Toxicological Effects of 14 Days of Ribose Ingestion and The Effects of Gender on Toxicology of 14 Days of Ribose Ingestion
Study Design: 14 consecutive days ingestion of D-ribose w ith hematological and hepatological investigation at days 0, 7 and 14
Test Substance & Dose: D-ribose 10-gm dose b.i.d. (20-gm/day)
Subjects: 19 healthy volunteers (8 female; 11 male)
Results: Ingestion of 20-gm/day ribose over a moderate (14 consecutive days) did not result in significant changes in hematological or hepatological variables. Variables considered
included Hb, Hct , RBC, WBC, platelet count, AL KP, GGT, ALT, AST and uric acid. A slight increase inurate levels were evident in day 7, but returned to baseline by day 14. No significant interactions of gender x time were evident.
Source: Frelich , A, and Seifer t, JG, et al.
St. Cloud State University, St. Cloud, MN
For presentation to FASEB April 2001
Data on file, Eniva Corp.
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