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

Sponsor

Hospital Universitari Vall d'Hebron Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT02063126

Collaborator

VITAE NATURAL NUTRITION, S.L. (Other)

Enrollment

Location

Arms

Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Jan 1, 2013

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

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 Names: 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 Names: Placebo (phosphoserine/serine plus vitamin C)

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 Names:

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 Names:

Placebo (phosphoserine/serine plus vitamin C)

Outcome Measures

Primary Outcome Measures

Maximum HR changes after ReConnect supplementation during an incremental exercise test in CFS patients [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

Perception of fatigue, pain and sleep disruption after ReConnect supplementation during an incremental exercise test in CFS patients [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.