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

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ClinicalTrials.gov Identifier: NCT02063126
Recruitment Status : Completed
First Posted : February 14, 2014
Last Update Posted : February 19, 2015
Sponsor:
Collaborator:
VITAE NATURAL NUTRITION, S.L.
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Brief 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

Condition or disease Intervention/treatment Phase
Chronic Fatigue Syndrome Dietary Supplement: ReConnect (NADH plus CoQ10) Dietary Supplement: placebo Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : January 2013
Actual Primary Completion Date : January 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
Active Comparator: ReConnect
CFS patients who were randomized to measure the effect of oral ReConnect supplementation (NADH: 20 mg/day, Coenzyme Q10: 200 mg/day; 4 tablets/day) on the maximum HR during 8-weeks in term.
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)

Other Name: Placebo

Placebo Comparator: Placebo
CFS patients who were randomized to measure the effect of oral Placebo supplementation ( phosphoserine and vitamin C, 4 tablets/day) on the maximum HR during 8-weeks in term.
Dietary Supplement: placebo
placebo (phosphoserine/serine plus vitamin C) supplementation divided in two daily doses (2 tablets/before brekfast and 2 tablets/before lunch)
Other Name: Placebo (phosphoserine/serine plus vitamin C)




Primary Outcome Measures :
  1. Maximum HR changes after ReConnect supplementation during an incremental exercise test in CFS patients [ Time Frame: within the first 30 days (plus or minus 15 days) after treatment ]
    Researchers hypothesize that the low maximun HR in CFS is tied to the brain via the autonomic nervous system, which regulates the body's automatic functions. Dysregulation of the autonomic nervous system is called dysautonomia and is believed to be a feature of CFS patients.


Secondary Outcome Measures :
  1. Perception of fatigue, pain and sleep disruption after ReConnect supplementation during an incremental exercise test in CFS patients [ Time Frame: within the first 30 days (plus or minus 15 days) ]
    Researchers hypothesize that perception of fatigue, pain and sleep disturbances in CFS is tied to the brain via the autonomic nervous system, which regulates the body's automatic functions. Dysregulation of the autonomic nervous system is called dysautonomia and is believed to be a feature of CFS patients.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients female between 18 and 65 years old.
  • CFS patients diagnosed with Chronic Fatigue Syndrome (CFS Clinical Unit, Vall d'Hebron Hospital, Barcelona, Spain)
  • Heart rate in radial pulse and seated between 50 to100 bpm, systolic BP between 100 to 140 mm Hg and diastolic BP between 50 to 90 mm Hg.
  • Patients who give a written informed consent before initiating the study.

Exclusion Criteria:

  • Patients for that is contraindicated or is not advisable to carry-out an ergometer exercise test.
  • Patients who are participating in another clinical trial of the same or differents nature in the last 30 days prior to inclusion.
  • Any participants who, in the opinion of the investigator, may not be able to follow instructions or make a good treatment compliance.
  • Subjects that do not give written informed consent to participate in the study.
  • Participants who are receiving any drug or banned substances and is expected that withdrawal of some medications/products not allowed in the study involves a significants problem.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02063126


Locations
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Spain
Vall Hebron University Hospital
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
VITAE NATURAL NUTRITION, S.L.
Investigators
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Principal Investigator: Jose Alegre-Martin, MD, PhD Vall d'Hebron University Hospital Research Institute. Internal Medicine Unit.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT02063126     History of Changes
Other Study ID Numbers: VITAE 01-2012
First Posted: February 14, 2014    Key Record Dates
Last Update Posted: February 19, 2015
Last Verified: February 2015
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Coenzyme Q10 plus NADH
maximum Heart Rate
Fatigue
Pain
Sleep
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Fatigue
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Vitamins
Ascorbic Acid
Coenzyme Q10
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents