NCT02063126

Clinical Trial to Measure the Maximun HR After ReConnect ® Supplementation vs. Placebo in CFS.

A Randomized, Double-blind, Placebo-controlled, Comparative Clinical Trial to Measure the Maximun Heart Rate During a Cycle Ergometer Test After ReConnect® Supplementation in CFS.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Fatigue Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	ReConnect (NADH plus CoQ10)	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)
DIETARY_SUPPLEMENT	placebo	placebo (phosphoserine/serine plus vitamin C) supplementation divided in two daily doses (2 tablets/before brekfast and 2 tablets/before lunch)

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-01-01
• Completion: 2013-12-01
• First posted: 2014-02-14
• Last updated: 2015-02-19

Locations

1 site across 1 country: Spain