Fatigue
Conditions
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.
Interventions
DIETARY_SUPPLEMENTD-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.
DIETARY_SUPPLEMENTDextrose
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.
Sponsors
Bioenergy Life Science, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ventilation Efficiency Slope | Two weeks |
| CPX parameters relative to placebo as measured by: | Two weeks |
| VO2 at AT | Two weeks |
| Net Energy Expenditure at AT | Two weeks |
| Oxygen Uptake Efficiency Slope | Two weeks |
| Heart rate to METS ratio at AT | Two weeks |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective will be to subjectively evaluate the subjects' level of fatigue and will be assessed by a serial questionnaire. | Two weeks |
Countries
United States
Outcome results
None listed