The food supplement Celergen was administered to fibromyalgia patients following a protocol of a daily intake for the period of a total of 3 months (90 days)

Fibromyalgia

The food supplement Celergen was administered on a daily basis for a total of 3 months (90 days) to participating fibromyalgia patients

Celergen Administration

Clinica DFK

Efficacy and Tolerability of CELERGEN in Fibromyalgia

A Prospective, Open-label, Study to Evaluate the Efficacy and Tolerability of the Food Supplement CELERGEN in Patients With Fibromyalgia

Scale measuring overall fibromyalgia symptoms (0-100) For each symptom-based item (Questions 14 - 20) the raw score ranges from 0 to 10. If the patient marks between 2 hash marks the item is given a score that includes 0.5. Do Job: (Question 14) Raw score is final score. Pain: (Question 15) Raw score is final score. Fatigue: (Question 16) Raw score is final score. Rested: (Question 17) Raw score is final score. Stiffness: (Question 18) Raw score is final score. Anxiety: (Question 19) Raw score is final score. Depression: (Question 20) Raw score is final score. In each instance, the final score is the sum of the scores for the Physical Impairment, Feel Good, Pain, Fatigue, Rested, Stiffness, Anxiety, and Depression scales (does not include 2 work items.)

Scale measuring pain frequency and intensity (0-10) Brief Pain Inventory (Short Form) 2. On the diagram, shade in the areas where you feel pain. Put an X on the area that hurts the most.
Yes No 0 1 2 3 4 5 6 7 8 9 10 0 1 2 3 4 5 6 7 8 9 10 0 1 2 3 4 5 6 7 8 9 10 4. Please rate your pain by marking the box beside the number that best describes your pain at its least in the last 24 hours. 6. Please rate your pain by marking the box beside the number that tells how much pain you have right now.
0 1 2 3 4 5 6 7

Scale measuring quality of life (0-100) Choose one option for each questionnaire item.
1. In general, would you say your health is:
- Excellent
- Very good
- Good
- Fair
- Poor
2. For how long (if at all) has your health limited you in each of the following activities?
Limited for more than 3 months Limited for 3 months or less Not limited at all
The kinds or amounts of vigorous activities you can do, like lifting heavy objects, running or participating in strenuous sports
1 2 3
The kinds or amounts of moderate activities you can do, like moving a table, carrying groceries, or bowling
1 2 3
Walking uphill or climbing a few flights of stairs
1 2 3
Bending, lifting, or stooping
1 2 3
Walking one block
1 2 3
Eating, dressing, bathing, or using the toilet
2 3 3. How much bodily pain have you had during the past 4 weeks:
- None
- Very mild
- Mild
- Moderate

Scale measuring overall improvement (0-7) Severity scale The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are:[1]
Normal, not at all ill Borderline mentally ill Mildly ill Moderately ill Markedly ill Severely ill Among the most extremely ill patients Improvement scale The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:[1]
Very much improved Much improved Minimally improved No change Minimally worse Much worse Very much worse

Celergan SA

The intervention consists in feeding the subjects egg, one a day for breakfast during 5 weeks. At the end of the intervention, blood will be obtained to measure plasma lipids, glucose, insulin and inflammatory markers. All measurements will be finished 24 weeks after the intervention is finished. All data will be reported 1 year after completion of the study.

In this arm, subjects will consume oatmeal for a period of 5 weeks. Blood samples will be taken and different parameters will be measured including plasma lipids, glucose, insulin and inflammatory markers. All these measurements will be finished 24 weeks after completion of the study. All data will be reported 1 year after completion of the study.

Diabetes Mellitus

Inflammation

One egg per day as breakfast for 5 weeks followed by a 3 week washout period and 5 additional weeks on oatmeal. This is a randomized crossover design. Half of subjects started with the eggs and the other half with oatmeal. Blood lipids, glucose and inflammatory measurements will be finished 24. weeks after completion of the study. Data will be reported 1 year after the completion of the study.

Egg, one a day, for breakfast

Subjects will be fed oatmeal for a period of 5 weeks. After 3 weeks they will be switched to the alternate diet. This is a randomized control trail in which plasma glucose, plasma lipids and inflammatory markers will be measured. All these measurements will be finished 24 weeks after completion of the study. Data will be reported after 1 year of the completion of the study.

Oatmeal, one cup a day

Centro de Investigacion y Desarrollo

Egg Effects on Atherogenic Dyslipidemias, Glucose Metabolism and Inflammation in Diabetic Subjects

Egg Effects on Atherogenic Dyslipidemia, Glucose Metabolism and Inflammation in Diabetic Subjects

Glycosylated hemoglobin had to be < 9% as one of the inclusion criteria. This parameter was assessed after 5 weeks that the subjects consumed the egg and after 5 weeks after the subjects were consuming the oatmeal.

This parameter was assessed to ensure that no significant changes in LDL cholesterol occurred by egg intake or oatmeal intake. LDL cholesterol was assessed after 5 weeks of consuming the eggs and 5 weeks of consuming the oatmeal.

This parameter was measured to determine whether egg intake favorably would affect inflammation in diabetic subjects. Tumor necrosis factor alpha was measured after 5 weeks of consuming the eggs and 5 weeks after consuming the oatmeal.

University of Connecticut

Test burgers with fresh avocado added just prior to consumption

Participants consumed 250 g cooked ground beef patty with or without 68 g fresh avocado added prior to ingestion.

Consumption of Beef Patty With or Without Avocado

Sex/Gender, Customized

Race/Ethnicity, Customized

Region of Enrollment

Change from baseline in reactive hyperemia index (RHI) in response to consumption of 250 g beef patty with or without 68 g avocado added at 2 hour post-ingestion. RHI is a measure of endothelial dysfunction using noninvasive peripheral arterial tonometry (PAT). It is a ratio of the post-to-pre occlusion PAT amplitude of the tested arm, divided by the post-to-pre occlusion ratio of the control arm. RHI less than 1.67 is considered sign of endothelial dysfunction and RHI equal to or greater than 1.67 is considered normal function. The possible range of scores is 1 to 3. Increasing score indicates the improvement of coronary endothelial function.

Participants consumed 250 g beef patties without avocado added

Participants Consumed 250 g Beef Patties Alone

Participants consumed 250 g beef patties with 68 g avocado added prior to ingestion.

Participants Consumed 250 g Beef Patties With Avocado Added

Change of Endothelial Function by Measurement of Flow-mediated Vasodilation Using the Reactive Hyperemia Index (RHI)

Change from baseline inflammatory marker IkB-alpha in response to the consumption of 250 g beef patty with or without 68 g avocado added was assessed at 0 (baseline), 1, 2, 3, 4, 5, 6 hours post-ingestion. Baseline and 3 hours post-ingestion was reported.

Participants consumed 250 g beef patties without avocado added prior to ingestion.

Consumption of Beef Patty Alone

Consumption of 250 g Beef Patty With Avocado Added

Change in Inflammation Marker Nuclear Factor of Kappa Light Polypeptide Gene Enhancer in B-cells Inhibitor Alpha (IkB-alpha)

Participants consumed 250 g cooked ground beef patty with or without avocado added prior to ingestion.

Consumption of Beef Patty With or Without Avocado Added

Consumption of Beef Patty With Avocado

Zhaoping Li

Change in peripheral arterial tonometry (PAT) after consuming meals consisting of a ground beef patty only.

Change in PAT After Consuming Beef Only

Change in peripheral arterial tonometry (PAT) after consuming meals consisting of a ground beef patty with 68 grams of avocado added.

Change in PAT After Comsuming Beef With Avocado

Healthy Volunteers

Avocado

UCLA Center for Human Nutriiton

Effects of Avocado When Added to a Meat Patty on Inflammation in Healthy Men

Hass Avocado Flesh Inhibition of Appearance of Lipid Peroxidation Products When Added to a Ground Beef Patty Consumed by Healthy Volunteers

Professor of Medicine

University of California, Los Angeles

Left-Sided Ulcerative Colitis

Proctosigmoiditis

PUR 0110 Rectal Enema 250 mg, once-daily, intrarectally

PUR 0110 Rectal Enema 250 mg

PUR 0110 Rectal Enema 500 mg, once-daily, intrarectally

PUR 0110 Rectal Enema 500 mg

PUR 0110 Rectal Enema 1000 mg, once-daily, intrarectally

PUR 0110 Rectal Enema 1000 mg

Placebo Enema

PurGenesis Investigational Site

Safety, Tolerability, Efficacy Study of PUR 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative Colitis

A 2-Week Exploratory Randomized, Double-Blind, Parallel-Group, Dose-Ranging, Placebo-Controlled Safety, Tolerability, Biomarker and Efficacy Clinical Study of PUR 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative Colitis

Safety & Tolerability of PUR0110 rectal enema compared to placebo as per Incidence, nature and severity of adverse events (AEs); and abnormal clinical laboratory test results.

Effectiveness of PUR0110 compared to placebo as per Clinical remission rate with clinical remission defined as an endoscopy score of ≤ 1, a rectal bleeding score of 0, and an improvement or no change from baseline in the stool frequency score at the end of 2 weeks of treatment / withdrawal visit.

Effectiveness of PUR0110 compared to placebo as per : Clinical response rate defined as the percentage of subjects with a drop of ≥3 points from the baseline overall modified Mayo score.

Effectiveness of PUR0110 compared to placebo as per Subject defined response and remission rates based on their well being : 1= much better; 2= some better; 3=a little better; 4= about the same; 5=a little worse; 6= some worse & 7= much worse.ed as : o= none; 1 = mild; 2=moderate, 3=severe and 4 = incapacitating.

Effectiveness of PUR0110 compared to placebo as per Change from baseline in the overall modified Mayo score.

Effectiveness of PUR0110 compared to placebo as per Change from baseline in each of the 4 individual sub-scores of the modified Mayo score.

Effectiveness of PUR0110 compared to placebo as per Change from baseline in investigator assessment of ulcerative colitis symptom score : 0= none; 1= Mild; 2=Moderate; 3=Severe and 4 = incapacitating

Effectiveness of PUR0110 compared to placebo as per Change from baseline in inflammatory bowel disease questionnaire (IBDQ) score.

Effectiveness of PUR0110 compared to placebo as per : Proportion of subjects with treatment failure;

Change from baseline in exploratory biomarkers - serum IL-2, IL-6, IL8, IFN-γ, TNF-α, TGF-β, IL-4, IL-10, IL-17, IL-23, hβD-2, MDA, LXA4, GSH and LTB4 levels in serum and biopsies; plasma and urinary isoprostane levels and serum lipoxin A4 levels..

Change from baseline in CRP, hs-CRP, ESR, FCP and FL .

Effect of PUR0110 on M30 apoptosome in serum and biopsies compared to placebo

Effect of PUR0110 on M65 apoptosome in serum and biopsies compared to placebo

lutein/nekrosis

Efficacy and Tolerability of CELERGEN in Fibromyalgia

Egg Effects on Atherogenic Dyslipidemias, Glucose Metabolism and Inflammation in Diabetic Subjects

Effects of Avocado When Added to a Meat Patty on Inflammation in Healthy Men

Safety, Tolerability, Efficacy Study of PUR 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative Colitis

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