Coenzyme Q10 Plus NADH Supplementation in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis
Condition: Chronic Fatigue Syndrome
MeSH terms: Fatigue Syndrome, Chronic; Syndrome; Fatigue
Study type: Interventional

Summary: 
      The main aim of the study is to examine the effect of oral CoQ10 plus NADH (Reconnect®)
      supplementation twice daily for 8-weeks on the changes in fatigue perception, sleep
      disturbances, autonomic dysfunction and HRQoL assessed by patient-reported outcome measures
      in CFS/ME.
    

Detailed description: 
      Chronic Fatigue Syndrome, as known as Myalgic Encephalomyelitis (CFS/ME) is a complex and
      extremely debilitating chronic condition, with no known cause, no established diagnostic
      tests, and no universal effective therapy. Its symptoms are mainly unexplained disabling
      fatigue that lasts for six months or more and that does not improve with rest, worsing with
      physical and mental activity. It is associated with other concomitant symptoms including
      muscle pain, post-exertional malaise lasting more than 24h, unrefreshing sleep, autonomic
      dysfunction and cognitive problems worsing quality of life of sufferers. Previous studies
      have shown that CFS/ME subjects have a significant decrease in CoQ10 and NADH levels in
      plasma and peripheral blood mononuclear cells (PBMCs), correlating with symptoms of the
      condition. Hypothesis: CoQ10 plus NADH administration could be beneficial in the improvement
      of outcome measures and molecular parameters in CFS/ME individuals.

      A total of 282 potentially eligible Caucasian CFS/ME subjects who meet both the 1994 Centers
      for Disease Control and Prevention/Fukuda's definition and 2003 Canadian case criteria for
      CFS/ME will be initially enrolled in the study. Those patients who don't meet the inclusion
      criteria will excluded of the study. All participants will be treatment with ReConnect®
      containing CoQ10 (50 mg) plus NADH (5 mg) vs. placebo twice daily for 8-weeks in term. Scores
      for fatigue perception, sleep problems, autonomic dysfunction and QoL will be assess by
      validated questionnaires of Fatigue Impact Scale (FIS-40), Pittsburgh Sleep Quality Index
      (PSQI), COMPASS-31 and HRV recording device, and HRQoL (36 item Short Form Health survey),
      respectively.

      The primary outcome is to evaluate the efficacy of oral CoQ10 plus NADH (Reconnect®)
      supplementation twice daily for 8-weeks on the changes in fatigue perception, sleep problems,
      autonomic dysfunction and health-related quality of life assessed by outcome measures in
      CFS/ME subjects.

      The secondary outcomes are to examine the effect of oral Reconnect® administration on fatigue
      perception (assessed by FIS-40), sleep disruption (PSQI), autonomic function (COMPASS-31),
      Heart Rate Variability (HRV) for measuring R-R intervals by mobile device coupled to the
      Polar H7 thoracic belt and HRQoL (36-items Short Form Health survey).
    

Intervention name(s): Coenzyme Q10 plus NADH; phosphoserine plus vitamin C
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Active arm: Coenzyme Q10 plus NADH CFS/ME patients who will be randomized to measure the effect of oral ReConnect supplementation (CoQ10: 200 mg/day plus NADH 20 mg/day; 4 tablets/day) on changes in the fatigue, sleep problems, autonomic function and HRQoL during 8-weeks in term.
Intervention: Reconnect; Placebo arm: phosphoserine plus vitamin C CFS/ME patients who will be randomized to measure the effect of oral Placebo supplementation (phosphoserine and vit C, 4 tablets/day) on changes in the fatigue, sleep problems, autonomic function and HRQoL during 8-weeks in term.
Intervention: placebo
Intervention MeSH terms: Coenzyme Q10; Ubiquinone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Active Dietary Supplement: ReConnect (CoQ10 plus NADH) and excipients. ReConnect supplementation (CoQ10: 200mg/day plus NADH 20 mg/day) divided into 2 daily dose (2 tablets/ before breakfast and 2 tablets/ before lunch).
Excipient Dietary Supplement: Placebo (serine plus vitamin C) Placebo supplementation divided into two daily dose (2 tablets/before breakfast and 2 tablets/ before lunch)
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: chronic fatigue; Sleep problems; Autonomic dysfunction; Health-Related Quality of Life; Coenzyme Q10; NADH