Clinical Trial to Measure the Maximun HR After ReConnect ® Supplementation vs. Placebo in CFS.
Condition: Chronic Fatigue Syndrome
MeSH terms: Fatigue Syndrome, Chronic; Fatigue
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The main objective is evaluate to safety and efficacy of oral Reconnect ® (food
      supplementation composed by Coenzyme Q10, NADH, phosphoserine y vitamin C) on the maximum HR
      during an exercise test in CFS
    

Detailed description: 
      Chronic Fatigue Syndrome (CFS) is a serious, complex and extremely debilitating chronic
      illness, but often misunderstood characterized by prolonged fatigue, the hallmark of the
      condition and multiple nonspecific symptoms. The World Health Organization has recognized CFS
      as a disease that affecting the nervous system (ICD-10 G93.3) and multiple body systems. The
      etiology is unknown. Previous studies have demonstrated in CFS patients a significant
      reduction in plasma and intracellular Peripheral Blood Mononuclear Cells concentrations of
      Coenzyme Q10 and NADH, which correlate with clinical symptoms of the disease. Hypothesis:
      Supplementation with CoQ10 plus NADH could be beneficial in the improvement of clinical and
      molecular parameters in this disease. The primary endpoint is to evaluate the efficacy of
      oral Reconnect ® suplementation on the maximum heart rate changes during an exercise test in
      CFS. The secondary endpoints are to evaluate the effect of Reconnect ® suplementation on
      perception of fatigue (assessed by FIS), pain (McGill Pain Index Questionnaire), and sleep
      disruption (Pittsburgh Sleep Index Questionnaire).

      Patients and Methods: A total of 80 consecutive women patients with a diagnosis of CFS
      according to the 1994 CDC Fukuda's definition criteria were initially evaluated and enrolled
      in this study. The majority were excluded for no meet the inclusion criteria of the study.
      All subjects are treatment with ReConnect® containing CoQ10 plus NADH versus placebo. Fatigue
      levels, pain and sleep disturbances are scored using the Fatigue Impact Scale, McGill Pain
      Questionnaire and Pittsburgh Sleep Quality Index, respectively.

      Discussion: To our knowledge, no previous studies have yet evaluated the effectiveness of
      oral ReConnect supplementation in CFS. ReConnect containing the combination of CoQ10 plus
      NADH and other nutrients (phosphoserine and Vitamin C) can help to improve clinical symptoms
      and restore mitochondrial function and oxidative stress reducing fatigue, pain and sleep
      impairments in CFS. The combination of these supplements can result in a safe and effective
      therapy to reduce fatigue, pain and improve sleep as well help restore quality of life of CFS
      patients.
    

Intervention name(s): ReConnect (NADH plus CoQ10); placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): ReConnect supplementation (NADH: 20 mg/day plus CoQ10: 200mg/day) divided into two daily dose ( 2 tablets/ before breakfast and 2 tablets/ before lunch)
Placebo supplementation divided into two daily dose ( 2 tablets/ before breakfast and 2 tablets/ before lunch); placebo (phosphoserine/serine plus vitamin C) supplementation divided in two daily doses (2 tablets/before brekfast and 2 tablets/before lunch)
Other intervention name(s): Placebo; Placebo (phosphoserine/serine plus vitamin C)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Coenzyme Q10 plus NADH; maximum Heart Rate; Fatigue; Pain; Sleep