NCT00821067

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

December 7, 2009

Status Verified

December 1, 2009

Enrollment Period

2 months

First QC Date

January 9, 2009

Last Update Submit

December 4, 2009

Conditions

Fatigue

Outcome Measures

Primary Outcomes (6)

  • CPX parameters relative to placebo as measured by:

    Two weeks

  • VO2 at AT

    Two weeks

  • Ventilation Efficiency Slope

    Two weeks

  • Oxygen Uptake Efficiency Slope

    Two weeks

  • Heart rate to METS ratio at AT

    Two weeks

  • Net Energy Expenditure at AT

    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.

    Two weeks

Study Arms (2)

1

ACTIVE COMPARATOR

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

Dietary Supplement: D-ribose

2

PLACEBO COMPARATOR

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

Dietary Supplement: Dextrose

Interventions

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.

1
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.

2

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aurora Denver Cardiology Association

Denver, Colorado, 80218, United States

Location

MeSH Terms

Conditions

Fatigue

Interventions

RiboseGlucose

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PentosesMonosaccharidesSugarsCarbohydratesHexoses

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 9, 2009

First Posted

January 13, 2009

Study Start

January 1, 2009

Primary Completion

March 1, 2009

Study Completion

May 1, 2009

Last Updated

December 7, 2009

Record last verified: 2009-12

Locations

US(1)