Clinical trial NCT00821067: The Effect of Oral D-Ribose in "Baby Boomers" With Fatigue. A Randomized, Double-Blind Study
Official title: The Effect of Oral D-Ribose in "Baby Boomers" With Fatigue. A Randomized, Double-Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Lead sponsor: Bioenergy Life Science, Inc.
Sponsor class: INDUSTRY
First posted: 2009-01-13
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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)

Primary outcomes:
measure: CPX parameters relative to placebo as measured by:
timeFrame: Two weeks
measure: VO2 at AT
timeFrame: Two weeks
measure: Ventilation Efficiency Slope
timeFrame: Two weeks
measure: Oxygen Uptake Efficiency Slope
timeFrame: Two weeks
measure: Heart rate to METS ratio at AT
timeFrame: Two weeks
measure: Net Energy Expenditure at AT
timeFrame: Two weeks
Secondary outcomes:
measure: The secondary objective will be to subjectively evaluate the subjects' level of fatigue and will be assessed by a serial questionnaire.
timeFrame: Two weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: Aurora Denver Cardiology Association
state: Colorado
Study officials:
References: