The Effect of Oral D-Ribose in Baby Boomers With Fatigue. A Randomized, Double-Blind Study

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Oral D-Ribose in Baby Boomers With Fatigue. A Randomized, Double-Blind Study

Conditions
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Fatigue

Intervention / Treatment
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* Dietary Supplement: D-ribose
* Dietary Supplement: Dextrose


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>A 6 gm/day (3 gm/bid) dose of D-ribose | Dietary Supplement: D-ribose<br>* 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.<br>|
| Placebo Comparator: 2<br>A 6 gm/day (3 gm/bid) dose of dextrose. | Dietary Supplement: Dextrose<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPX parameters relative to placebo as measured by: |  | Two weeks | 
| VO2 at AT |  | Two weeks | 
| Ventilation Efficiency Slope |  | Two weeks | 
| Oxygen Uptake Efficiency Slope |  | Two weeks | 
| Heart rate to METS ratio at AT |  | Two weeks | 
| Net Energy Expenditure at AT |  | Two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |