Chronic Fatigue SyndromePhase 2/3ReConnectNCT02063126
Clinical Trial to Measure the Maximun HR After ReConnect ® Supplementation vs. Placebo in CFS.
A Phase 2/3 study testing ReConnect (NADH plus CoQ10) in people with Chronic Fatigue Syndrome, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Chronic Fatigue Syndrome
- What is being tested?
- ReConnect (NADH plus CoQ10)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2013to Dec 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
Read the 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
- Being tested
- ReConnect (NADH plus CoQ10), placebo
- Keywords
- Coenzyme Q10 plus NADH, maximum Heart Rate, Fatigue, Pain, Sleep
- Medical subject headings
- Fatigue Syndrome, Chronic, Fatigue, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReConnect (NADH plus CoQ10)Dietary supplement
Also called Placebo
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)
placeboDietary supplement
Also called Placebo (phosphoserine/serine plus vitamin C)
placebo (phosphoserine/serine plus vitamin C) supplementation divided in two daily doses (2 tablets/before brekfast and 2 tablets/before lunch)
| Study group | Role | What they receive |
|---|---|---|
| ReConnect | Active comparator | 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. Receives: Dietary Supplement: ReConnect (NADH plus CoQ10) |
| Placebo | Placebo comparator | 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. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum HR changes after ReConnect supplementation during an incremental exercise test in CFS patients
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.
Measured: within the first 30 days (plus or minus 15 days) after treatment
Secondary outcomes (1)
Perception of fatigue, pain and sleep disruption after ReConnect supplementation during an incremental exercise test in CFS patients
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.
Measured: within the first 30 days (plus or minus 15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startJan 2013
- Primary completionJan 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- VITAE NATURAL NUTRITION, S.L.
- Responsible party
- Sponsor
- Investigators
- Jose Alegre-Martin, MD, PhD, Principal investigator, Vall d'Hebron University Hospital Research Institute. Internal Medicine Unit.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063126
- Sponsor's protocol ID
- VITAE 01-2012
- Acronym
- ReConnect
- Status last verified
- Feb 2015
- First submitted
- 5 Feb 2014
- Last updated
- 19 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Castro-Marrero J, Saez-Francas N, Segundo MJ, Calvo N, Faro M, Aliste L, Fernandez de Sevilla T, Alegre J. Effect of coenzyme Q10 plus nicotinamide adenine dinucleotide supplementation on maximum heart rate after exercise testing in chronic fatigue syndrome - A randomized, controlled, double-blind trial. Clin Nutr. 2016 Aug;35(4):826-34. doi: 10.1016/j.clnu.2015.07.010. Epub 2015 Jul 17.
PubMed 26212172Castro-Marrero J, Cordero MD, Segundo MJ, Saez-Francas N, Calvo N, Roman-Malo L, Aliste L, Fernandez de Sevilla T, Alegre J. Does oral coenzyme Q10 plus NADH supplementation improve fatigue and biochemical parameters in chronic fatigue syndrome? Antioxid Redox Signal. 2015 Mar 10;22(8):679-85. doi: 10.1089/ars.2014.6181. Epub 2014 Dec 18.
PubMed 25386668
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02063126
- Acronym / sponsor ID
- ReConnect / VITAE 01-2012
- Conditions
- Chronic Fatigue Syndrome
- Keywords
- Coenzyme Q10 plus NADH, maximum Heart Rate, Fatigue, Pain, Sleep
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- VITAE NATURAL NUTRITION, S.L.
- Study start
- Jan 2013
- Primary completion
- Jan 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ReConnect | Active comparator | Dietary Supplement: ReConnect (NADH plus CoQ10)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. |
| Placebo | Placebo comparator | Dietary Supplement: placeboCFS 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReConnect (NADH plus CoQ10)Also: PlaceboReConnect 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 | ReConnect |
| placeboAlso: Placebo (phosphoserine/serine plus vitamin C)placebo (phosphoserine/serine plus vitamin C) supplementation divided in two daily doses (2 tablets/before brekfast and 2 tablets/before lunch) | Dietary supplement | Placebo |
Primary outcome
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.
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2015.
- Derived from this study: PubMed 26212172Castro-Marrero J, Saez-Francas N, Segundo MJ, Calvo N, Faro M, Aliste L, Fernandez de Sevilla T, Alegre J. Effect of coenzyme Q10 plus nicotinamide adenine dinucleotide supplementation on maximum heart rate after exercise testing in chronic fatigue syndrome - A randomized, controlled, double-blind trial. Clin Nutr. 2016 Aug;35(4):826-34. doi: 10.1016/j.clnu.2015.07.010. Epub 2015 Jul 17.
- Derived from this study: PubMed 25386668Castro-Marrero J, Cordero MD, Segundo MJ, Saez-Francas N, Calvo N, Roman-Malo L, Aliste L, Fernandez de Sevilla T, Alegre J. Does oral coenzyme Q10 plus NADH supplementation improve fatigue and biochemical parameters in chronic fatigue syndrome? Antioxid Redox Signal. 2015 Mar 10;22(8):679-85. doi: 10.1089/ars.2014.6181. Epub 2014 Dec 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Alegre-Martin, MD, PhD principal investigator
Vall d'Hebron University Hospital Research Institute. Internal Medicine Unit.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ReConnect (NADH plus CoQ10) in people with Chronic Fatigue Syndrome, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02063126, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2015.