<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03288389</url>
  </required_header>
  <id_info>
    <org_study_id>2017/02/1</org_study_id>
    <nct_id>NCT03288389</nct_id>
  </id_info>
  <brief_title>Membrane Lipid Replacement in Fibromyalgia</brief_title>
  <official_title>Membrane Lipid Replacement in Fibromyalgia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute for Molecular Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute for Molecular Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the clinical effectiveness of an all-natural,&#xD;
      patented wafer with active ingredients that are FDA approved as Generally Recognized as Safe&#xD;
      (GRAS) Reference: US Federal Drug Administration (1970) Scientific Literature Reviews GRAS&#xD;
      Report, PB-241 970. Active Ingredients: Lecithins. .In this study the investigators will&#xD;
      evaluate the efficacy of this dietary product called NTFactor Lipids® made by Nutritional&#xD;
      Therapeutics, Inc. of New York on pain, fatigue and gastrointestinal symptoms as well as&#xD;
      quality of life indicators in adult male and female participants with fibromyalgia. The&#xD;
      addition of NTFactor Lipids to the diet is expected to improve cellular energy function,&#xD;
      decrease fatigue and pain and lower the severity of other symptoms and improve quality of&#xD;
      life indicators in Fibromyalgia. This study will be a randomized, placebo-controlled,&#xD;
      cross-over study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adult male and female volunteers (n=60, aged 18-64) with a diagnosis of Fibromyalgia will be&#xD;
      recruited by referral, newspapers, flyers, radio and internet ads, and asked to complete an&#xD;
      Informed Consent document and take an on-line, validated, Combined Fibromyalgia Symptom&#xD;
      Questionnaire or Survey Form. Potentially eligible participants (Since there are approx.&#xD;
      twice as many female as male patients with this diagnosis, the investigators anticipate that&#xD;
      more female than male participants will be recruited) will have the Fibromyalgia diagnosis&#xD;
      confirmed using the American College of Rheumatology criteria. If participants have not done&#xD;
      so, participants will be asked to provide 10 cc of blood for a Chem 20 analysis. Participants&#xD;
      that meet the inclusion criteria will be randomized into placebo (42 days) or supplement arms&#xD;
      (4 g NTFactor Lipids® per day for 42 days) by a Research Nurse/Associate, and blinded to the&#xD;
      Principal Investigators and Participants for this cross-over trial. After the first arm is&#xD;
      completed, participants will return for a clinic visit and enter the second arm for 42 days&#xD;
      after a 2-week wash-out period. Once the data has been collected online (at Day 0 before&#xD;
      starting supplement/placebo and on Days 1, 2, 3, 7, 14, 21, 30 and 42 for each arm), data&#xD;
      will be placed into spread sheets, unblinded and analyzed by an independent statistical unit&#xD;
      at the University of California, Irvine, School of Medicine. Principal objectives will be to&#xD;
      assess various categories of pain, fatigue, GI symptoms and QOL and compare these outcomes in&#xD;
      this study among supplement and placebo arms for each participant over time and combined for&#xD;
      all participants. Statistical significance of any differences will be determined by t-test&#xD;
      and other methods. Regression analysis of the data will be used to assess fidelity of the&#xD;
      data and reliability of outcomes, and R2 values will be calculated for combined data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    until further notice due to COVID-19 pandemic.&#xD;
  </why_stopped>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Anticipated">June 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Fatigue as assessed by validated survey form</measure>
    <time_frame>through study completion at 14 weeks</time_frame>
    <description>Fatigue elements and overall fatigue will be self reported ten times in each six week phase</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain as assessed by validated survey form</measure>
    <time_frame>through study completion at 14 weeks</time_frame>
    <description>Pain elements will be self reported ten times in each six week phase</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gastrointestinal symptoms as assessed by validated survey form</measure>
    <time_frame>through study completion at 14 weeks</time_frame>
    <description>Gastrointestinal symptoms will be self reported ten times in each six week phase</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life as assessed by validated survey form</measure>
    <time_frame>through study completion at 14 weeks</time_frame>
    <description>QOL elements will be self reported ten times in each six week phase</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NTFactor Lipids®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>NTFactor Lipids®</intervention_name>
    <description>Membrane Lipid Replacement with NTFactor Lipids wafers</description>
    <arm_group_label>NTFactor Lipids®</arm_group_label>
    <other_name>Patented Energy wafers</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo wafers</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. You are an adult male or female (aged 18-70).&#xD;
&#xD;
          2. You have Fibromyalgia or a related clinical condition.&#xD;
&#xD;
          3. You are mobile during the day.&#xD;
&#xD;
          4. You are willing to sign an informed consent document.&#xD;
&#xD;
          5. You are willing to have 10 cc (two teaspoons) of blood drawn for analysis.&#xD;
&#xD;
          6. You are willing to take part in a clinical study that will last 14 weeks.&#xD;
&#xD;
          7. You have internet access and an email address.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. You are not an adult.&#xD;
&#xD;
          2. You do not have Fibromyalgia or a related clinical condition.&#xD;
&#xD;
          3. You are not mobile, spending more than 10 hours per day in bed.&#xD;
&#xD;
          4. You are not willing and able to sign an informed consent document.&#xD;
&#xD;
          5. You are not able to be present at a test location or have a blood draw of 10 cc (2&#xD;
             teaspoons) for blood analysis.&#xD;
&#xD;
          6. You have unusually high or low values on your blood chemistry screen.&#xD;
&#xD;
          7. You are pregnant&#xD;
&#xD;
          8. You have been declared mentally incompetent by a qualified health care professional.&#xD;
&#xD;
          9. You have a positive diagnosis of cancer, HIV, hepatitis and other major illnesses,&#xD;
             such as severe hypertension, neurodegenerative or autoimmune disease.&#xD;
&#xD;
         10. You on immune suppressing drugs or medications.&#xD;
&#xD;
         11. You are legally barred from signing and informed consent document.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nancy C Russell, DrPH</last_name>
    <role>Study Director</role>
    <affiliation>Independent Research Coordinator</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Priority Health &amp; Wellness</name>
      <address>
        <city>Pearland</city>
        <state>Texas</state>
        <zip>77581</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Office of Dr. Paul Breeding</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blue Hole Wellness</name>
      <address>
        <city>Wimberley</city>
        <state>Texas</state>
        <zip>78676</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>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 Biomembr. 2017 Sep;1859(9 Pt B):1704-1724. doi: 10.1016/j.bbamem.2017.04.013. Epub 2017 Apr 18.</citation>
    <PMID>28432031</PMID>
  </results_reference>
  <results_reference>
    <citation>Nicolson GL, Rosenblatt S, de Mattos GF, 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 (Craiova). 2016 Feb 18;4(1):e54. doi: 10.15190/d.2016.1.</citation>
    <PMID>32309576</PMID>
  </results_reference>
  <results_reference>
    <citation>Nicolson GL. Mitochondrial Dysfunction and Chronic Disease: Treatment With Natural Supplements. Integr Med (Encinitas). 2014 Aug;13(4):35-43.</citation>
    <PMID>26770107</PMID>
  </results_reference>
  <results_reference>
    <citation>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;</citation>
  </results_reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>April 16, 2020</last_update_submitted>
  <last_update_submitted_qc>April 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institute for Molecular Medicine</investigator_affiliation>
    <investigator_full_name>Garth Nicolson, PhD, MD (H)</investigator_full_name>
    <investigator_title>President &amp; Chief Scientific Officer</investigator_title>
  </responsible_party>
  <keyword>Membrane Lipid Replacement</keyword>
  <keyword>NTFactor Lipids</keyword>
  <keyword>Fibromyalgia</keyword>
  <keyword>Pain</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Gastrointestinal symptoms</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03288389
org study id: 2017/02/1
nct id: NCT03288389
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
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.
primary purpose: Treatment
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.
measure: Fatigue as assessed by validated survey form
time frame: through study completion at 14 weeks
description: Fatigue elements and overall fatigue will be self reported ten times in each six week phase
measure: Pain as assessed by validated survey form
time frame: through study completion at 14 weeks
description: Pain elements will be self reported ten times in each six week phase
measure: Gastrointestinal symptoms as assessed by validated survey form
time frame: through study completion at 14 weeks
description: Gastrointestinal symptoms will be self reported ten times in each six week phase
measure: Quality of Life as assessed by validated survey form
time frame: through study completion at 14 weeks
description: QOL elements will be self reported ten times in each six week phase
arm group label: Placebo
arm group type: Placebo Comparator
description: 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.
arm group label: NTFactor Lipids®
arm group type: Active Comparator
description: 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.
intervention type: Dietary Supplement
intervention name: NTFactor Lipids®
description: Membrane Lipid Replacement with NTFactor Lipids wafers
arm group label: NTFactor Lipids®
other name: Patented Energy wafers
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo wafers
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Nancy C Russell, DrPH
role: Study Director
affiliation: Independent Research Coordinator
facility: 
facility: 
facility: 
country: United States
citation: 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 Biomembr. 2017 Sep;1859(9 Pt B):1704-1724. doi: 10.1016/j.bbamem.2017.04.013. Epub 2017 Apr 18.
PMID: 28432031
citation: Nicolson GL, Rosenblatt S, de Mattos GF, 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 (Craiova). 2016 Feb 18;4(1):e54. doi: 10.15190/d.2016.1.
PMID: 32309576
citation: Nicolson GL. Mitochondrial Dysfunction and Chronic Disease: Treatment With Natural Supplements. Integr Med (Encinitas). 2014 Aug;13(4):35-43.
PMID: 26770107
citation: 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 type: Principal Investigator
investigator affiliation: Institute for Molecular Medicine
investigator full name: Garth Nicolson, PhD, MD (H)
investigator title: President & Chief Scientific Officer
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
sharing ipd: No