Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT00821067
Status:
COMPLETED
Last Update Posted:
2009-12-07
First Post:
2009-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Oral D-Ribose in "Baby Boomers" With Fatigue. A Randomized, Double-Blind Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012266', 'term': 'Ribose'}, {'id': 'D005947', 'term': 'Glucose'}], 'ancestors': [{'id': 'D010429', 'term': 'Pentoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D006601', 'term': 'Hexoses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-04', 'studyFirstSubmitDate': '2009-01-09', 'studyFirstSubmitQcDate': '2009-01-12', 'lastUpdatePostDateStruct': {'date': '2009-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CPX parameters relative to placebo as measured by:', 'timeFrame': 'Two weeks'}, {'measure': 'VO2 at AT', 'timeFrame': 'Two weeks'}, {'measure': 'Ventilation Efficiency Slope', 'timeFrame': 'Two weeks'}, {'measure': 'Oxygen Uptake Efficiency Slope', 'timeFrame': 'Two weeks'}, {'measure': 'Heart rate to METS ratio at AT', 'timeFrame': 'Two weeks'}, {'measure': 'Net Energy Expenditure at AT', 'timeFrame': 'Two weeks'}], 'secondaryOutcomes': [{'measure': "The secondary objective will be to subjectively evaluate the subjects' level of fatigue and will be assessed by a serial questionnaire.", 'timeFrame': 'Two weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fatigue']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Presents with complaint of fatigue with duration longer than one month\n* Males/Females between the ages of 50 and 65 years of age\n* No previous clinical diagnosis of pulmonary, cardiac or metabolic disorders based on history\n* Capable of performing a sub-maximal incremental treadmill exercise using cardiopulmonary analysis methods\n* Normal blood pressure or those with mild, untreated pre-hypertension (\\>120/70 or \\< 140/90 mmHg)\n* Able to be compliant with the supplement regimen, repeat clinical visits and completion of the study questionnaires\n* Must be able to understand the consent form, agree to participate, and to execute their signature\n\nExclusion Criteria:\n\n* Not presently taking any adenine nucleotide enhancing supplements\n* History of non-compliance in previous studies\n* Known to be pregnant\n* Uncontrolled cardiac arrhythmias causing symptoms or unstable hemodynamics\n* Moderate to severe gout\n* A diagnosis of arthritis of the lower extremities\n* Mental impairment, inability to cooperate\n* History of acute non-cardiopulmonary disorder that may affect exercise performance, (e.g. infection, renal failure, thyrotoxicosis, etc.)\n* Any disorder or condition that in the opinion of the study physician would render exercise unsafe or would impact exercise performance\n* Any person who is incarcerated, or on a work release program\n\nAdditional Exclusions observed and sequelae during initial baseline evaluation:\n\n* Drop in systolic blood pressure of \\>10 mm Hg from baseline despite an increase in workload, when accompanied by other evidence of ischemia\n* Moderately severe angina\n* Increasing nervous system symptoms (e.g. ataxia, dizziness, or near syncope)\n* Signs of poor perfusion (cyanosis or pallor)\n* Technical difficulties monitoring the ECG or systolic blood pressure\n* Subject's desire to stop\n* Sustained ventricular tachycardia\n* Electrocardiographic ST elevation (+1.0 mm) in leads without diagnostic Q-waves (other than V1 or aVR)"}, 'identificationModule': {'nctId': 'NCT00821067', 'briefTitle': 'The Effect of Oral D-Ribose in "Baby Boomers" With Fatigue. A Randomized, Double-Blind Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bioenergy Life Science, Inc.'}, 'officialTitle': 'The Effect of Oral D-Ribose in "Baby Boomers" With Fatigue. A Randomized, Double-Blind Study', 'orgStudyIdInfo': {'id': 'FS20081121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'A 6 gm/day (3 gm/bid) dose of D-ribose', 'interventionNames': ['Dietary Supplement: D-ribose']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'A 6 gm/day (3 gm/bid) dose of dextrose.', 'interventionNames': ['Dietary Supplement: Dextrose']}], 'interventions': [{'name': 'D-ribose', 'type': 'DIETARY_SUPPLEMENT', '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.', 'armGroupLabels': ['1']}, {'name': 'Dextrose', 'type': 'DIETARY_SUPPLEMENT', '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.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Aurora Denver Cardiology Association', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bioenergy Life Science, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Jeff Thompson', 'oldOrganization': 'Bioenergy Life Science, Inc.'}}}}