Membrane Lipid Replacement in Fibromyalgia

Study Description

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Brief Summary:

The purpose of this study is to determine the clinical effectiveness of an all-natural, patented wafer with active ingredients that are FDA approved as Generally Recognized as Safe (GRAS) Reference: US Federal Drug Administration (1970) Scientific Literature Reviews GRAS Report, PB-241 970. Active Ingredients: Lecithins. .In this study the investigators will evaluate the efficacy of this dietary product called NTFactor Lipids® made by Nutritional Therapeutics, Inc. of New York on pain, fatigue and gastrointestinal symptoms as well as quality of life indicators in adult male and female participants with fibromyalgia. The addition of NTFactor Lipids to the diet is expected to improve cellular energy function, decrease fatigue and pain and lower the severity of other symptoms and improve quality of life indicators in Fibromyalgia. This study will be a randomized, placebo-controlled, cross-over study.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Dietary Supplement: NTFactor Lipids®; Dietary Supplement: Placebo	Not Applicable

Detailed Description:

Adult male and female volunteers (n=60, aged 18-64) with a diagnosis of Fibromyalgia will be recruited by referral, newspapers, flyers, radio and internet ads, and asked to complete an Informed Consent document and take an on-line, validated, Combined Fibromyalgia Symptom Questionnaire or Survey Form. Potentially eligible participants (Since there are approx. twice as many female as male patients with this diagnosis, the investigators anticipate that more female than male participants will be recruited) will have the Fibromyalgia diagnosis confirmed using the American College of Rheumatology criteria. If participants have not done so, participants will be asked to provide 10 cc of blood for a Chem 20 analysis. Participants that meet the inclusion criteria will be randomized into placebo (42 days) or supplement arms (4 g NTFactor Lipids® per day for 42 days) by a Research Nurse/Associate, and blinded to the Principal Investigators and Participants for this cross-over trial. After the first arm is completed, participants will return for a clinic visit and enter the second arm for 42 days after a 2-week wash-out period. Once the data has been collected online (at Day 0 before starting supplement/placebo and on Days 1, 2, 3, 7, 14, 21, 30 and 42 for each arm), data will be placed into spread sheets, unblinded and analyzed by an independent statistical unit at the University of California, Irvine, School of Medicine. Principal objectives will be to assess various categories of pain, fatigue, GI symptoms and QOL and compare these outcomes in this study among supplement and placebo arms for each participant over time and combined for all participants. Statistical significance of any differences will be determined by t-test and other methods. Regression analysis of the data will be used to assess fidelity of the data and reliability of outcomes, and R2 values will be calculated for combined data.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Intervention Model Description:	The purpose of this study is to determine the clinical effectiveness of an all-natural, patented, Food and Drug Administration (FDA)-approved oral lipid nutritional supplement (NTFactor Lipids) on reducing pain, fatigue and other symptoms and improving quality of life in Fibromyalgia and other related conditions. The investigators will evaluate the efficacy of a dietary product called NTFactor Lipids made by Nutritional Therapeutics, Inc. of New York on pain, fatigue and gastrointestinal symptoms as well as quality of life indicators in adult male and female subjects. The addition of NTFactor Lipids to the diet is expected to improve cellular energy function, decrease fatigue and pain and lower the severity of other symptoms and improve quality of life indicators in Fibromyalgia patients. This study will be a randomized, placebo-controlled, cross-over study.
Masking:	Triple (Participant, Care Provider, Investigator)
Masking Description:	Participants will be randomized by a nurse consultant into placebo and supplement arms and will be masked from lead investigator, physician participants and research nurse coordinator. Placebo and Product will be in identical white numbered bottles and look, feel, taste and smell the same. Data will be collected independently online by a specialty company and after the trial is completed, it will be transferred to an independent statistical unit at the University of California, Irvine for analysis and at that time the code will be broken for analysis purposes.
Primary Purpose:	Treatment
Official Title:	Membrane Lipid Replacement in Fibromyalgia
Actual Study Start Date :	May 1, 2017
Estimated Primary Completion Date :	October 2018
Estimated Study Completion Date :	October 2018

Arms and Interventions

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Arm	Intervention/treatment
Placebo Comparator: Placebo; Participants will take 4 placebo wafers per day for 42 days. Subjects will be asked to take the Fibromyalgia Combined Symptom Survey (see attachments, based on validated survey instruments) on-line on Day 0 (before starting supplement/placebo) and on Days 1, 2, 3, 7, 14, 21, 30 and 42.	Dietary Supplement: Placebo; Placebo wafers
Active Comparator: NTFactor Lipids®; Participants will take 4 NTFactor Lipid® wafers (4 g) per day for 42 days. Subjects will be asked to take the Fibromyalgia Combined Symptom Survey (see attachments, based on validated survey instruments) on-line on Day 0 (before starting supplement/placebo) and on Days 1, 2, 3, 7, 14, 21, 30 and 42.	Dietary Supplement: NTFactor Lipids®; Membrane Lipid Replacement with NTFactor Lipids wafers; Other Name: Patented Energy wafers

Outcome Measures

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Primary Outcome Measures :

1. Fatigue [ Time Frame: through study completion, an average of 3 months ]
   Fatigue elements and overall fatigue will be assessed by validated survey form
2. Pain [ Time Frame: through study completion, an average of 3 months ]
   Pain elements will be assessed by validated survey form
3. Gastrointestinal symptoms [ Time Frame: through study completion, an average of 3 months ]
   Gastrointestinal symptoms will be assessed by validated survey form

Secondary Outcome Measures :

1. Quality of Life [ Time Frame: through study completion, an average of 3 months ]
   QOL elements will be assessed by validated survey form

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 64 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. You are an adult male or female (aged 18-64).
2. You have Fibromyalgia or a related clinical condition.
3. You are mobile during the day.
4. You are willing to sign an informed consent document.
5. You are willing to have a teaspoon of blood drawn for analysis.
6. You are willing to take part in a clinical study that will last 14 weeks.
7. You have internet access and an email address.

Exclusion Criteria:

1. You are not an adult.
2. You do not have Fibromyalgia or a related clinical condition.
3. You are not mobile, spending more than 10 hours per day in bed.
4. You are not willing and able to sign an informed consent document.
5. You are not able to be present at a test location or have a blood draw of 10 cc (4 Tablsp) for blood analysis.
6. You have unusually high or low values on your blood chemistry screen.
7. You are pregnant
8. You have been declared mentally incompetent by a qualified health care professional.
9. You have a positive diagnosis of cancer, HIV, hepatitis and other major illnesses, such as severe hypertension, neurodegenerative or autoimmune disease.
10. You on immune suppressing drugs or medications.
11. You are legally barred from signing and informed consent document.

Contacts and Locations

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Contacts

Contact: Garth L Nicolson, PhD/MD	949-715-5978	gnicolson@immed.org
Contact: Paul Breeding, DC	512-831-8088	drpaulcbreeding@yahoo.com

Locations

United States, Texas
First Health	Recruiting
Beaumont, Texas, United States, 77706
Contact: Paul C Breeding, DC 512-831-8088
First Health	Recruiting
Pearland, Texas, United States, 78581
Contact: Paul C Breeding, DC 512-831-8088
Office of Dr. Paul Breeding	Recruiting
San Antonio, Texas, United States, 78209
Contact: Paul C Breediing, DC 512-831-8088
Blue Hole Wellness	Recruiting
Wimberley, Texas, United States, 78676
Contact: Nancy C Russell, DrPH 281-798-5031 nanrussl@hotmail.com

Sponsors and Collaborators

Institute for Molecular Medicine

Investigators

Study Director:	Nancy C Russell, DrPH	Independent Research Coordinator

More Information

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Publications of Results:

Nicolson GL, Ash ME. Membrane Lipid Replacement for chronic illnesses, aging and cancer using oral glycerolphospholipid formulations with fructooligosaccharides to restore phospholipid function in cellular membranes, organelles, cells and tissues. Biochim Biophys Acta. 2017 Sep;1859(9 Pt B):1704-1724. doi: 10.1016/j.bbamem.2017.04.013. Epub 2017 Apr 18. Review.

Nicolson GL, Rosenblatt S, Ferreira de Mattos G, Settineri R, Breeding PC, Ellithorpe RR, Ash ME. Clinical uses of Membrane Lipid Replacement supplements in restoring membrane function and reducing fatigue in chronic diseases and cancer. Discoveries, 4(1): e54, 2016.

Nicolson GL. Mitochondrial Dysfunction and Chronic Disease: Treatment With Natural Supplements. Integr Med (Encinitas). 2014 Aug;13(4):35-43.

Nicolson GL. Membrane Lipid Replacement: clinical studies using a natural medicine approach to restoring membrane function and improving health. International Journal of Clinical Medicine 7: 133-143, 2016;

Responsible Party:	Garth Nicolson, PhD, MD (H), President & Chief Scientific Officer, Institute for Molecular Medicine
ClinicalTrials.gov Identifier:	NCT03288389 History of Changes
Other Study ID Numbers:	2017/02/1
First Posted:	September 20, 2017
Last Update Posted:	April 27, 2018
Last Verified:	April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Garth Nicolson, PhD, MD (H), Institute for Molecular Medicine:

Membrane Lipid Replacement; NTFactor Lipids; Fibromyalgia	Pain; Faigue; Gastrointestinal symptoms

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases	Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases