Expired Study
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Denver, Colorado 80218


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.


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)


NCT ID:

NCT00821067


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Denver, Colorado 80218
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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