Membrane Lipid Replacement in Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Membrane Lipid Replacement in Fibromyalgia

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03288389
• Other study ID #: 2017/02/1
• Status: Suspended
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: June 1, 2023

Study information

• Verified date: April 2020
• Source: Institute for Molecular Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 60
• Est. completion date: June 1, 2023
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. You are an adult male or female (aged 18-70).

2. You have Fibromyalgia or a related clinical condition.

3. You are mobile during the day.

4. You are willing to sign an informed consent document.

5. You are willing to have 10 cc (two teaspoons) of blood drawn for analysis.

6. You are willing to take part in a clinical study that will last 14 weeks.

7. You have internet access and an email address.

Exclusion Criteria:

1. You are not an adult.

2. You do not have Fibromyalgia or a related clinical condition.

3. You are not mobile, spending more than 10 hours per day in bed.

4. You are not willing and able to sign an informed consent document.

5. You are not able to be present at a test location or have a blood draw of 10 cc (2 teaspoons) for blood analysis.

6. You have unusually high or low values on your blood chemistry screen.

7. You are pregnant

8. You have been declared mentally incompetent by a qualified health care professional.

9. You have a positive diagnosis of cancer, HIV, hepatitis and other major illnesses, such as severe hypertension, neurodegenerative or autoimmune disease.

10. You on immune suppressing drugs or medications.

11. You are legally barred from signing and informed consent document.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Dietary Supplement:
• NTFactor Lipids®
Membrane Lipid Replacement with NTFactor Lipids wafers
• Placebo
Placebo wafers

Locations

Country	Name	City	State
United States	Priority Health & Wellness	Pearland	Texas
United States	Office of Dr. Paul Breeding	San Antonio	Texas
United States	Blue Hole Wellness	Wimberley	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Institute for Molecular Medicine

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Nicolson GL, Rosenblatt S, Ferreira de Mattos G, 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, 4(1)

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;

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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