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Membrane Lipid Replacement in Fibromyalgia

This study is currently recruiting participants.
Verified October 2017 by Garth Nicolson, PhD, MD (H), Institute for Molecular Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT03288389
First Posted: September 20, 2017
Last Update Posted: October 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Garth Nicolson, PhD, MD (H), Institute for Molecular Medicine
  Purpose
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 Intervention
Fibromyalgia Dietary Supplement: NTFactor Lipids® Dietary Supplement: Placebo

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Garth Nicolson, PhD, MD (H), Institute for Molecular Medicine:

Primary Outcome Measures:
  • Fatigue [ Time Frame: through study completion, an average of 3 months ]
    Fatigue elements and overall fatigue will be assessed by validated survey form

  • Pain [ Time Frame: through study completion, an average of 3 months ]
    Pain elements will be assessed by validated survey form

  • Gastrointestinal symptoms [ Time Frame: through study completion, an average of 3 months ]
    Gastrointestinal symptoms will be assessed by validated survey form


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


Estimated Enrollment: 60
Actual Study Start Date: May 1, 2017
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03288389


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
Blue Hole Wellness Recruiting
San Antonio, Texas, United States, 78209
Contact: Nancy C Russell, DRPH    512-547-5007      
Blue Hole Wellness Recruiting
Wimberley, Texas, United States, 78676
Contact: Nancy C Russell, DrPH    512-547-5007      
Sponsors and Collaborators
Institute for Molecular Medicine
Investigators
Study Director: Nancy C Russell, DrPH Independent Research Coordinator
  More Information

Publications:
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. 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 Submitted: September 13, 2017
First Posted: September 20, 2017
Last Update Posted: October 10, 2017
Last Verified: October 2017
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