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

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.

Study Overview

• Status: Completed
• Conditions: Fatigue
• Intervention / Treatment: Dietary supplement: D-ribose; Dietary supplement: Dextrose

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80218
      • Aurora Denver Cardiology Association

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; A 6 gm/day (3 gm/bid) dose of D-ribose	Dietary supplement: D-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.
Placebo Comparator: 2; A 6 gm/day (3 gm/bid) dose of dextrose.	Dietary supplement: Dextrose; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Bioenergy Life Science, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: January 9, 2009
• First Submitted That Met QC Criteria: January 12, 2009
• First Posted (Estimate): January 13, 2009

Study Record Updates

• Last Update Posted (Estimate): December 7, 2009
• Last Update Submitted That Met QC Criteria: December 4, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: FS20081121