The Effect of Oral D-Ribose in "Baby Boomers" With Fatigue. A Randomized, Double-Blind Study
NCT ID: NCT00821067
Last Updated: 2009-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
40 participants
INTERVENTIONAL
2009-01-31
2009-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
A 6 gm/day (3 gm/bid) dose of D-ribose
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.
2
A 6 gm/day (3 gm/bid) dose of dextrose.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
50 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bioenergy Life Science, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bioenergy Life Science, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Aurora Denver Cardiology Association
Denver, Colorado, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FS20081121
Identifier Type: -
Identifier Source: org_study_id