CONNeCT: Coenzyme Q10 Plus NADH Supplementation in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis

Sponsor

Hospital Universitari Vall d'Hebron Research Institute (Other)

Overall Status

Unknown status

CT.gov ID

NCT03186027

Collaborator

VITAE NATURAL NUTRITION, S.L. (Other)

282

Enrollment

Location

Arms

18.1

Anticipated Duration (Months)

15.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Fatigue Syndrome	Dietary Supplement: Coenzyme Q10 plus NADH Dietary Supplement: phosphoserine plus vitamin C	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

282 participants

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)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)

Masking Description:

The investigator, care provider and participants do not know which individuals have been assigned in each arm or comparison group.

Primary Purpose:

Treatment

Official Title:

Effect of Coenzyme Q10 Plus NADH Supplementation on the Changes in Fatigue Perception, Sleep Disturbances, Autonomic Function and Health-related Quality of Life in CFS/ME - A Randomized, Placebo-controlled, Double-blind Trial.

Actual Study Start Date :

Jun 28, 2017

Anticipated Primary Completion Date :

Oct 31, 2018

Anticipated Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Active supplement (CoQ10 plus NADH) CFS/ME patients will be randomized to evaluate the effect of oral ReConnect supplementation (CoQ10: 200 mg/day plus NADH: 20 mg/day) taking 4 tablets/day during 8-weeks in term. Active supplement based on Coenzyme Q10 plus NADH	Dietary Supplement: Coenzyme Q10 plus NADH 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 Comparator: Phosphoserine plus vitamin C CFS/ME patients will be randomized to assess the effect of placebo (phospho-serine plus vitamin C) taking 4 tablets/day for 8-weeks in term. Placebo: phosphoserine plus vitamin C	Dietary Supplement: phosphoserine plus vitamin C 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

Arm

Intervention/Treatment

Active Comparator: Active supplement (CoQ10 plus NADH)

CFS/ME patients will be randomized to evaluate the effect of oral ReConnect supplementation (CoQ10: 200 mg/day plus NADH: 20 mg/day) taking 4 tablets/day during 8-weeks in term. Active supplement based on Coenzyme Q10 plus NADH

Dietary Supplement: Coenzyme Q10 plus NADH

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 Comparator: Phosphoserine plus vitamin C

CFS/ME patients will be randomized to assess the effect of placebo (phospho-serine plus vitamin C) taking 4 tablets/day for 8-weeks in term. Placebo: phosphoserine plus vitamin C

Dietary Supplement: phosphoserine plus vitamin C

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

Outcome Measures

Primary Outcome Measures

Effect of oral Reconnect ® (CoQ10 plus NADH) supplementation on the changes in core symptoms during 8-weeks in CFS/ME subjects. [At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)]
Evaluate the effect of oral Reconnect ® supplementation on the changes in fatigue perception measured by the Fatigue Index Scale-40 (40 items) in all study participants. Items Rate: 0 (no fatigue) to 4 (severe fatigue).

Secondary Outcome Measures

Demographic data and clinical parameters [At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)]
Sex
Age of onset of symptoms [At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)]
Age at onset of fatigue
Concomitant conditions [At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)]
Comorbid illnesses associated with ME/CFS
Height will be measured and reported [At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)]
Height in meters
Weight will be measured and reported [At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)]
Weight in kilograms
Body Mass Index (BMI) [At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)]
Height and Weight will be combined to report BMI in kg/m^2
Sleep Quality [At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)]
Pittsburgh Quality of Sleep Index (18 items) for non-refreshing sleep
Autonomic Function [At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)]
COMPASS-31 Questionnaire (31-items) to assess autonomic dysfunction
Heart Rate Variability (HRV) recording device [At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)]
Time domain - NN (normal-to-normal R-R interval), HRV index (total number of all NN/ the height of the histogram of all NN), SDNN (standard deviation of the NN), RMSSD (the root mean square of differences of successive NN), NN50 (number of pairs of adjacent NN intervals differing by more than 50 ms in the entire recording) and pNN50(NN50/total number of all NN). Frequency domain - TP (the variance of NN intervals over the temporal segment), VLF(power in very low frequency range; < 0.04 Hz), LF (Power in low frequency range; 0.04~0.15 Hz), HF(Power in high frequency range; 0.15~0.4 Hz).
Health-Related Quality of Life SF36 survey [At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)]
Short Form-36 Health Survey (36-items) to measure quality of life of participants.

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.
Body Mass Index (BMI) ≤ 30 mg/m²
Subjects who met the 1994 Centers for Disease Control and Prevention/Fukuda definition and 2003 Canadian diagnostic criteria for CFS/ME.
Patients must be able to participate, understand and complete questionnaires in Spanish language.
Patients who give a signed informed consent before initiating the study.

Exclusion Criteria:

Patients who do not fulfilled the 1994 Centers for Disease Control and Prevention/Fukuda definition and 2003 Canadian criteria for CFS/ME.
Patients who are participating in another clinical trial of the same or different nature in the last 30 days prior to inclusion.
Any participants who, in the opinion of the principal investigator, may not be able to follow instructions or make a good treatment compliance.
Subjects that don't give signed 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 significant problem.
Participants who are pregnant and/or breastfeeding,
Participants with autoimmune disorder, cancer, endocrine and metabolic disorders, rheumatic conditions, multiple sclerosis, psychosis, major depression, cardiovascular disease, hematological conditions, use of oral anticoagulants, smokers or had a history of substance abuse.