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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT03288389
Other study ID # 2017/02/1
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
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
Health authority
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 LipidsĀ® 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.

Study Design


Related Conditions & MeSH terms


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
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