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

Bioenergy Life Science

Status

Completed

Conditions

Fatigue

Treatments

Dietary Supplement: D-ribose

Dietary Supplement: Dextrose

Study type

Interventional

Funder types

Industry

Identifiers

NCT00821067

FS20081121

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

50 to 65 years old

Volunteers

Accepts Healthy Volunteers

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)