Status:
COMPLETED
The Effect of Oral D-Ribose in "Baby Boomers" With Fatigue. A Randomized, Double-Blind Study
Lead Sponsor:
Bioenergy Life Science, Inc.
Conditions:
Fatigue
Eligibility:
All Genders
50-65 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00821067
Start Date
January 1 2009
End Date
May 1 2009
Last Update
December 7 2009
Active Locations (1)
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1
Aurora Denver Cardiology Association
Denver, Colorado, United States, 80218