Membrane Lipid Replacement in Fibromyalgia

NCT03288389 | Suspended

• 1 other identifier: 2017/02/1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Membrane Lipid Replacement; NTFactor Lipids; Fibromyalgia; Pain; Fatigue; Gastrointestinal symptoms

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Quality of Life as assessed by validated survey form

  through study completion at 14 weeks

Study Arms (2)

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.

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.

Dietary Supplement: NTFactor Lipids®

Interventions

NTFactor Lipids® DIETARY_SUPPLEMENT

Membrane Lipid Replacement with NTFactor Lipids wafers

Also known as: Patented Energy wafers

NTFactor Lipids®

Placebo DIETARY_SUPPLEMENT

Placebo wafers

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Institute for Molecular Medicine: lead

Study Sites (3)

Priority Health & Wellness

Pearland, Texas, 77581, United States

Location

Office of Dr. Paul Breeding

San Antonio, Texas, 78209, United States

Location

Blue Hole Wellness

Wimberley, Texas, 78676, United States

Location

Related Publications (4)

• 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.

  PMID: 28432031 RESULT

• Nicolson 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.

  PMID: 32309576 RESULT

• Nicolson GL. Mitochondrial Dysfunction and Chronic Disease: Treatment With Natural Supplements. Integr Med (Encinitas). 2014 Aug;13(4):35-43.

  PMID: 26770107 RESULT

• Nicolson 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;

  RESULT

MeSH Terms

Conditions

Fibromyalgia; Pain; Fatigue

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nancy C Russell, DrPH

  Independent Research Coordinator

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President & Chief Scientific Officer

Model Details: 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.

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 20, 2017
• Study Start: May 1, 2017
• Primary Completion: May 1, 2022
• Study Completion: June 1, 2023
• Last Updated: April 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)