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Membrane Lipid Replacement in Fibromyalgia

NCT03288389 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-04-20

No results posted yet for this study

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. 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.

Conditions

  • Fibromyalgia

Interventions

DIETARY_SUPPLEMENT

NTFactor Lipids®

Membrane Lipid Replacement with NTFactor Lipids wafers

DIETARY_SUPPLEMENT

Placebo

Placebo wafers

Sponsors & Collaborators

  • Institute for Molecular Medicine

    lead OTHER

Principal Investigators

  • Nancy C Russell, DrPH · Independent Research Coordinator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2022-05-01
Completion
2023-06-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03288389 on ClinicalTrials.gov