The Effect of Oral D-Ribose in "Baby Boomers" With Fatigue. A Randomized, Double-Blind, Multi-Center Study - Full Text View

Sponsored by:	Bioenergy Life Science, Inc.
Information provided by:	Bioenergy Life Science, Inc.
ClinicalTrials.gov Identifier:	NCT00821067

Purpose

D-ribose, a natural occurring pentose carbohydrate, has repeatedly shown to enhance high-energy phosphates and improve function following ischemia, states of congestive heart failure, and recently in subjects with lung disease. An initial preliminary, open label pilot study demonstrated a positive benefit of D-ribose in "Baby-Boomer" subjects aged 50 to 65 years old complaining of persistent fatigue. The objective of this study will build on the previously collected data to evaluate oral D-ribose vs. dextrose (administered as a supplement) in relatively healthy, yet fatigued subjects with a goal of improving their state of fatigue.

Condition	Intervention
Fatigue	Dietary Supplement: D-ribose Dietary Supplement: Dextrose

MedlinePlus related topics: Dietary Supplements

Drug Information available for: Dextrose Ribose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study
Official Title:	The Effect of Oral D-Ribose in "Baby Boomers" With Fatigue. A Randomized, Double-Blind, Multi-Center Study

Further study details as provided by Bioenergy Life Science, Inc.:

Primary Outcome Measures:

CPX parameters relative to placebo as measured by: [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
VO2 at AT [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
Ventilation Efficiency Slope [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
Oxygen Uptake Efficiency Slope [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
Heart rate to METS ratio at AT [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
Net Energy Expenditure at AT [ Time Frame: Two weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary objective will be to subjectively evaluate the subjects' level of fatigue and will be assessed by a serial questionnaire. [ Time Frame: Two weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	January 2009
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator A 6 gm/day (3 gm/bid) dose of D-ribose	Dietary Supplement: D-ribose A 6 gm/day (3 gm/bid) dose of D-ribose in water. Each subject will consume oral D-ribose, dissolved in 8 fl. oz of water (1 serving) twice daily, for 2 weeks.
2: Placebo Comparator A 6 gm/day (3 gm/bid) dose of dextrose.	Dietary Supplement: Dextrose A 6 gm/day (3 gm/bid) dose of dextrose in water. Each subject will consume oral dextrose, dissolved in 8 fl. oz of water (1 serving) twice daily, for 2 weeks.

Eligibility

Ages Eligible for Study:	50 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Presents with complaint of fatigue with duration longer than one month
Males/Females between the ages of 50 and 65 years of age
No previous clinical diagnosis of pulmonary, cardiac or metabolic disorders based on history
Capable of performing a sub-maximal incremental treadmill exercise using cardiopulmonary analysis methods
Normal blood pressure or those with mild, untreated pre-hypertension (>120/70 or < 140/90 mmHg)
Able to be compliant with the supplement regimen, repeat clinical visits and completion of the study questionnaires
Must be able to understand the consent form, agree to participate, and to execute their signature

Exclusion Criteria:

Not presently taking any adenine nucleotide enhancing supplements
History of non-compliance in previous studies
Known to be pregnant
Uncontrolled cardiac arrhythmias causing symptoms or unstable hemodynamics
Moderate to severe gout
A diagnosis of arthritis of the lower extremities
Mental impairment, inability to cooperate
History of acute non-cardiopulmonary disorder that may affect exercise performance, (e.g. infection, renal failure, thyrotoxicosis, etc.)
Any disorder or condition that in the opinion of the study physician would render exercise unsafe or would impact exercise performance
Any person who is incarcerated, or on a work release program

Additional Exclusions observed and sequelae during initial baseline evaluation:

Drop in systolic blood pressure of >10 mm Hg from baseline despite an increase in workload, when accompanied by other evidence of ischemia
Moderately severe angina
Increasing nervous system symptoms (e.g. ataxia, dizziness, or near syncope)
Signs of poor perfusion (cyanosis or pallor)
Technical difficulties monitoring the ECG or systolic blood pressure
Subject's desire to stop
Sustained ventricular tachycardia
Electrocardiographic ST elevation (+1.0 mm) in leads without diagnostic Q-waves (other than V1 or aVR)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821067

Locations

United States, Colorado
Aurora Denver Cardiology Association
Denver, Colorado, United States, 80218
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001

Sponsors and Collaborators

Bioenergy Life Science, Inc.

Investigators

Study Director:

Dean MacCarter, PhD

Aurora Denver Cardiology Association

More Information

Responsible Party:	Bioenergy Life Science, Inc. ( Jeff Thompson )
Study ID Numbers:	FS20081121
Study First Received:	January 9, 2009
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00821067
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Signs and Symptoms
Fatigue

ClinicalTrials.gov processed this record on January 16, 2009