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| Name | Class |
|---|---|
| VITAE NATURAL NUTRITION, S.L. | UNKNOWN |
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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReConnect (NADH plus CoQ10) | Dietary Supplement | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within the first 30 days (plus or minus 15 days) after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Alegre-Martin, MD, PhD | Vall d'Hebron University Hospital Research Institute. Internal Medicine Unit. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vall Hebron University Hospital | Barcelona | Barcelona | 08035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26212172 | Derived | 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. | |
| 25386668 |
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| ID | Term |
|---|---|
| D015673 | Fatigue Syndrome, Chronic |
| D005221 | Fatigue |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
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| ID | Term |
|---|---|
| D009243 | NAD |
| C024989 | coenzyme Q10 |
| D010768 | Phosphoserine |
| D012694 | Serine |
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D000227 | Adenine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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|
|
| placebo | Dietary Supplement | placebo (phosphoserine/serine plus vitamin C) supplementation divided in two daily doses (2 tablets/before brekfast and 2 tablets/before lunch) |
|
|
| within the first 30 days (plus or minus 15 days) |
| Derived |
| Castro-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. |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D019606 | Phosphoamino Acids |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |