Membrane Lipid Replacement in Fibromyalgia
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03288389 |
Recruitment Status :
Suspended
(until further notice due to COVID-19 pandemic.)
First Posted : September 20, 2017
Last Update Posted : April 20, 2020
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Condition or disease | Intervention/treatment | Phase |
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Fibromyalgia | Dietary Supplement: NTFactor Lipids® Dietary Supplement: Placebo | Not Applicable |
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 : | May 1, 2022 |
Estimated Study Completion Date : | June 1, 2023 |

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.
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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.
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Dietary Supplement: NTFactor Lipids®
Membrane Lipid Replacement with NTFactor Lipids wafers
Other Name: Patented Energy wafers |
- 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
- Quality of Life as assessed by validated survey form [ Time Frame: through study completion at 14 weeks ]QOL elements will be self reported ten times in each six week phase

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 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
United States, Texas | |
Priority Health & Wellness | |
Pearland, Texas, United States, 77581 | |
Office of Dr. Paul Breeding | |
San Antonio, Texas, United States, 78209 | |
Blue Hole Wellness | |
Wimberley, Texas, United States, 78676 |
Study Director: | Nancy C Russell, DrPH | Independent Research Coordinator |
Responsible Party: | Garth Nicolson, PhD, MD (H), President & Chief Scientific Officer, Institute for Molecular Medicine |
ClinicalTrials.gov Identifier: | NCT03288389 |
Other Study ID Numbers: |
2017/02/1 |
First Posted: | September 20, 2017 Key Record Dates |
Last Update Posted: | April 20, 2020 |
Last Verified: | April 2020 |
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 |
Membrane Lipid Replacement NTFactor Lipids Fibromyalgia |
Pain Fatigue Gastrointestinal symptoms |
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |