Membrane Lipid Replacement in Fibromyalgia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Membrane Lipid Replacement in Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Dietary Supplement: NTFactor Lipids®
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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<br>* Placebo wafers<br>|
| Active Comparator: NTFactor Lipids®<br>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®<br>* Membrane Lipid Replacement with NTFactor Lipids wafers<br>* Other names: Patented Energy wafers;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue as assessed by validated survey form | Fatigue elements and overall fatigue will be self reported ten times in each six week phase | 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 | 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 | through study completion at 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life as assessed by validated survey form | QOL elements will be self reported ten times in each six week phase | through study completion at 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Membrane Lipid Replacement, NTFactor Lipids, Fibromyalgia, Pain, Fatigue, Gastrointestinal symptoms