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Completed

NCT Number: NCT00821067

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.

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Key information

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aurora Denver Cardiology Association

Denver, Colorado, 80218, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

D-ribose

Dietary Supplement

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

Dietary Supplement

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.

Primary outcomes

  1. CPX parameters relative to placebo as measured by:

    Time frame: Two weeks

  2. VO2 at AT

    Time frame: Two weeks

  3. Ventilation Efficiency Slope

    Time frame: Two weeks

  4. Oxygen Uptake Efficiency Slope

    Time frame: Two weeks

  5. Heart rate to METS ratio at AT

    Time frame: Two weeks

  6. Net Energy Expenditure at AT

    Time frame: Two weeks

Secondary outcomes

  1. The secondary objective will be to subjectively evaluate the subjects' level of fatigue and will be assessed by a serial questionnaire.

    Time frame: Two weeks

Sponsors and collaborators

Lead sponsor

Bioenergy Life Science, Inc.

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 13, 2009
Registry last updated
Dec 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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