Membrane Lipid Replacement in Fibromyalgia

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.

Inclusion Criteria:

1. You are an adult male or female (aged 18-64).

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 a teaspoon 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 (4
Tablsp) 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.