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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00821067
• Other study ID #: FS20081121
• Status: Completed
• Phase: N/A
• First received: January 9, 2009
• Last updated: December 4, 2009
• Start date: January 2009
• Est. completion date: May 2009

Study information

• Verified date: December 2009
• Source: Bioenergy Life Science, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Aurora Denver Cardiology Association	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Bioenergy Life Science, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CPX parameters relative to placebo as measured by:		Two weeks	No
Primary	VO2 at AT		Two weeks	No
Primary	Ventilation Efficiency Slope		Two weeks	No
Primary	Oxygen Uptake Efficiency Slope		Two weeks	No
Primary	Heart rate to METS ratio at AT		Two weeks	No
Primary	Net Energy Expenditure at AT		Two weeks	No
Secondary	The secondary objective will be to subjectively evaluate the subjects' level of fatigue and will be assessed by a serial questionnaire.		Two weeks	No