The Effect of Oral D-Ribose in "Baby Boomers" With Fatigue. A Randomized, Double-Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- CPX parameters relative to placebo as measured by:
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
2
A 6 gm/day (3 gm/bid) dose of dextrose.
干预措施: Dextrose (Dietary Supplement)
1
A 6 gm/day (3 gm/bid) dose of D-ribose
干预措施: D-ribose (Dietary Supplement)
结局指标
主要结局
CPX parameters relative to placebo as measured by:
时间窗: Two weeks
VO2 at AT
时间窗: Two weeks
Ventilation Efficiency Slope
时间窗: Two weeks
Oxygen Uptake Efficiency Slope
时间窗: Two weeks
Heart rate to METS ratio at AT
时间窗: Two weeks
Net Energy Expenditure at AT
时间窗: Two weeks
次要结局
- The secondary objective will be to subjectively evaluate the subjects' level of fatigue and will be assessed by a serial questionnaire.(Two weeks)