Membrane Lipid Replacement in Fibromyalgia

Paused · Not applicable · Has a placebo group

Conditions studied: Fibromyalgia

In brief

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.

Key facts

Study ID

NCT03288389

Run by

Institute for Molecular Medicine

People needed

60

Starts

2017-05-01

Expected to finish

2023-06-01

Last updated by the study team

2020-04-20

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Priority Health & Wellness — Pearland, Texas, United States
• Office of Dr. Paul Breeding — San Antonio, Texas, United States
• Blue Hole Wellness — Wimberley, Texas, United States

Full record on ClinicalTrials.gov

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