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

Primary Purpose

Fatigue

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
D-ribose
Dextrose
Sponsored by
Bioenergy Life Science, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

  • Aurora Denver Cardiology Association

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

A 6 gm/day (3 gm/bid) dose of D-ribose

A 6 gm/day (3 gm/bid) dose of dextrose.

Outcomes

Primary Outcome Measures

CPX parameters relative to placebo as measured by:
VO2 at AT
Ventilation Efficiency Slope
Oxygen Uptake Efficiency Slope
Heart rate to METS ratio at AT
Net Energy Expenditure at AT

Secondary Outcome Measures

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

Full Information

First Posted
January 9, 2009
Last Updated
December 4, 2009
Sponsor
Bioenergy Life Science, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00821067
Brief Title
The Effect of Oral D-Ribose in "Baby Boomers" With Fatigue. A Randomized, Double-Blind Study
Official Title
The Effect of Oral D-Ribose in "Baby Boomers" With Fatigue. A Randomized, Double-Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bioenergy Life Science, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
A 6 gm/day (3 gm/bid) dose of D-ribose
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
A 6 gm/day (3 gm/bid) dose of dextrose.
Intervention Type
Dietary Supplement
Intervention Name(s)
D-ribose
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dextrose
Intervention Description
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 Outcome Measure Information:
Title
CPX parameters relative to placebo as measured by:
Time Frame
Two weeks
Title
VO2 at AT
Time Frame
Two weeks
Title
Ventilation Efficiency Slope
Time Frame
Two weeks
Title
Oxygen Uptake Efficiency Slope
Time Frame
Two weeks
Title
Heart rate to METS ratio at AT
Time Frame
Two weeks
Title
Net Energy Expenditure at AT
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Aurora Denver Cardiology Association
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States

12. IPD Sharing Statement

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

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