FibromyalgiaNCT03288389
Membrane Lipid Replacement in Fibromyalgia
A study testing NTFactor Lipids® in people with Fibromyalgia, run by Institute for Molecular Medicine at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- NTFactor Lipids®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 May 2017to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- You are an adult male or female (aged 18-70).
- You have Fibromyalgia or a related clinical condition.
- You are mobile during the day.
- You are willing to sign an informed consent document.
- You are willing to have 10 cc (two teaspoons) of blood drawn for analysis.
- You are willing to take part in a clinical study that will last 14 weeks.
- You have internet access and an email address.
Who cannot join
- You are not an adult.
- You do not have Fibromyalgia or a related clinical condition.
- You are not mobile, spending more than 10 hours per day in bed.
- You are not willing and able to sign an informed consent document.
- You are not able to be present at a test location or have a blood draw of 10 cc (2 teaspoons) for blood analysis.
- You have unusually high or low values on your blood chemistry screen.
Show all 11Show fewer
- You are pregnant
- You have been declared mentally incompetent by a qualified health care professional.
- You have a positive diagnosis of cancer, HIV, hepatitis and other major illnesses, such as severe hypertension, neurodegenerative or autoimmune disease.
- You on immune suppressing drugs or medications.
- You are legally barred from signing and informed consent document.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Priority Health & Wellness
Pearland, Texas, 77581
Office of Dr. Paul Breeding
San Antonio, Texas, 78209
Blue Hole Wellness
Wimberley, Texas, 78676
About this study
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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- NTFactor Lipids®, Placebo
- Keywords
- Membrane Lipid Replacement, NTFactor Lipids, Fibromyalgia, Pain, Fatigue, Gastrointestinal symptoms
- Medical subject headings
- Fibromyalgia, Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTFactor Lipids®Dietary supplement
Also called Patented Energy wafers
Membrane Lipid Replacement with NTFactor Lipids wafers
PlaceboDietary supplement
Placebo wafers
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Placebo |
| NTFactor Lipids® | Active comparator | 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. Receives: Dietary Supplement: NTFactor Lipids® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue as assessed by validated survey form
Fatigue elements and overall fatigue will be self reported ten times in each six week phase
Measured: through study completion at 14 weeks
Pain as assessed by validated survey form
Pain elements will be self reported ten times in each six week phase
Measured: through study completion at 14 weeks
Gastrointestinal symptoms as assessed by validated survey form
Gastrointestinal symptoms will be self reported ten times in each six week phase
Measured: through study completion at 14 weeks
Secondary outcomes (1)
Quality of Life as assessed by validated survey form
QOL elements will be self reported ten times in each six week phase
Measured: through study completion at 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start1 May 2017
- Primary completion1 May 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Why it stopped: until further notice due to COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Molecular Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Garth Nicolson, PhD, MD (H), Institute for Molecular Medicine
- Investigators
- Nancy C Russell, DrPH, Study director, Independent Research Coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288389
- Sponsor's protocol ID
- 2017/02/1
- Status last verified
- Apr 2020
- First submitted
- 13 Sep 2017
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28432031Nicolson 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.
PubMed 32309576Nicolson GL. Mitochondrial Dysfunction and Chronic Disease: Treatment With Natural Supplements. Integr Med (Encinitas). 2014 Aug;13(4):35-43.
PubMed 26770107Nicolson 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;
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Membrane Lipid Replacement in Fibromyalgia
- ClinicalTrials.gov ID
- NCT03288389
- Acronym / sponsor ID
- 2017/02/1
- Conditions
- Fibromyalgia
- Keywords
- Membrane Lipid Replacement, NTFactor Lipids, Fibromyalgia, Pain, Fatigue, Gastrointestinal symptoms
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: until further notice due to COVID-19 pandemic.
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Institute for Molecular MedicineUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 20 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants 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. |
| NTFactor Lipids® | Active comparator | Dietary Supplement: 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- You are an adult male or female (aged 18-70).
- You have Fibromyalgia or a related clinical condition.
- You are mobile during the day.
- You are willing to sign an informed consent document.
- You are willing to have 10 cc (two teaspoons) of blood drawn for analysis.
Key exclusion criteria (11 listed)
- You are not an adult.
- You do not have Fibromyalgia or a related clinical condition.
- You are not mobile, spending more than 10 hours per day in bed.
- You are not willing and able to sign an informed consent document.
- You are not able to be present at a test location or have a blood draw of 10 cc (2 teaspoons) for blood analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTFactor Lipids®Also: Patented Energy wafersMembrane Lipid Replacement with NTFactor Lipids wafers | Dietary supplement | NTFactor Lipids® |
| PlaceboPlacebo wafers | Dietary supplement | Placebo |
Primary outcome
Fatigue as assessed by validated survey form
Time frame: through study completion at 14 weeks
Fatigue elements and overall fatigue will be self reported ten times in each six week phase
Pain as assessed by validated survey form
Time frame: through study completion at 14 weeks
Pain elements will be self reported ten times in each six week phase
Gastrointestinal symptoms as assessed by validated survey form
Time frame: through study completion at 14 weeks
Gastrointestinal symptoms will be self reported ten times in each six week phase
1 secondary outcome
Quality of Life as assessed by validated survey form
Time frame: through study completion at 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Results publication: PubMed 28432031Nicolson 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.
- Results publication: PubMed 32309576Nicolson 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.
- Results publication: PubMed 26770107Nicolson GL. Mitochondrial Dysfunction and Chronic Disease: Treatment With Natural Supplements. Integr Med (Encinitas). 2014 Aug;13(4):35-43.
- Results publicationNicolson 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;
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy C Russell, DrPH study director
Independent Research Coordinator
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NTFactor Lipids® in people with Fibromyalgia, run by Institute for Molecular Medicine at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue as assessed by validated survey form (time frame: through study completion at 14 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03288389, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.