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

NCT02063126 | Completed Phase 2 DMC

• 1 other identifier: VITAE 01-2012
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Fatigue Syndrome

Keywords

Coenzyme Q10 plus NADH; maximum Heart Rate; Fatigue; Pain; Sleep

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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)

Study Arms (2)

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.

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.

Dietary Supplement: placebo

Interventions

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)

Also known as: Placebo

ReConnect

placebo DIETARY_SUPPLEMENT

placebo (phosphoserine/serine plus vitamin C) supplementation divided in two daily doses (2 tablets/before brekfast and 2 tablets/before lunch)

Also known as: Placebo (phosphoserine/serine plus vitamin C)

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients for that is contraindicated or is not advisable to carry-out an ergometer exercise test.
• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• VITAE NATURAL NUTRITION, S.L.: collaborator

Study Sites (1)

Vall Hebron University Hospital

Barcelona, Barcelona, 08035, Spain

Location

Related Publications (2)

• 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.

  PMID: 26212172 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.

  PMID: 25386668 DERIVED

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Fatigue; Pain

Interventions

NAD; coenzyme Q10; Phosphoserine; Serine; Ascorbic Acid

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins; Phosphoamino Acids; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Jose Alegre-Martin, MD, PhD

  Vall d'Hebron University Hospital Research Institute. Internal Medicine Unit.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2014
• First Posted: February 14, 2014
• Study Start: January 1, 2013
• Primary Completion: January 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 19, 2015

Record last verified: 2015-02

Locations

ES (1)