FatigueNCT00821067
The Effect of Oral D-Ribose in "Baby Boomers" With Fatigue. A Randomized, Double-Blind Study
A study testing D-ribose and Dextrose in people with Fatigue, run by Bioenergy Life Science, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- D-ribose and Dextrose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to May 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Aurora Denver Cardiology Association
Denver, Colorado, 80218
About this 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.
- Conditions
- Fatigue
- Being tested
- D-ribose, Dextrose
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-riboseDietary 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.
DextroseDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | A 6 gm/day (3 gm/bid) dose of D-ribose Receives: Dietary Supplement: D-ribose |
| 2 | Placebo comparator | A 6 gm/day (3 gm/bid) dose of dextrose. Receives: Dietary Supplement: Dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPX parameters relative to placebo as measured by:
Measured: Two weeks
VO2 at AT
Measured: Two weeks
Ventilation Efficiency Slope
Measured: Two weeks
Oxygen Uptake Efficiency Slope
Measured: Two weeks
Heart rate to METS ratio at AT
Measured: Two weeks
Net Energy Expenditure at AT
Measured: 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.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioenergy Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821067
- Sponsor's protocol ID
- FS20081121
- Status last verified
- Dec 2009
- First submitted
- 9 Jan 2009
- Last updated
- 7 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral D-Ribose in "Baby Boomers" With Fatigue. A Randomized, Double-Blind Study
- ClinicalTrials.gov ID
- NCT00821067
- Acronym / sponsor ID
- FS20081121
- Conditions
- Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bioenergy Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 13 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: D-riboseA 6 gm/day (3 gm/bid) dose of D-ribose |
| 2 | Placebo comparator | Dietary Supplement: DextroseA 6 gm/day (3 gm/bid) dose of dextrose. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-riboseA 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. | Dietary supplement | 1 |
| DextroseA 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. | Dietary supplement | 2 |
Primary outcome
CPX parameters relative to placebo as measured by:
Time frame: Two weeks
VO2 at AT
Time frame: Two weeks
Ventilation Efficiency Slope
Time frame: Two weeks
Oxygen Uptake Efficiency Slope
Time frame: Two weeks
Heart rate to METS ratio at AT
Time frame: Two weeks
Net Energy Expenditure at AT
Time frame: Two weeks
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D-ribose and Dextrose in people with Fatigue, run by Bioenergy Life Science, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPX parameters relative to placebo as measured by: (time frame: Two weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2009; AzTrials last refreshed its copy on 8 Nov 2026.