After an 8-10 hour overnight fast, Group A will receive two soft capsules of TPGS (400mg) emulsified berberine. Following a 7 day wash out period, Group A participants will then receive four capsules of the Quillaja extract emulsified berberine (200mg). Following another 7 day wash out period, Group A participants will then receive two hard shell capsules of the berberine reference powder 400mg. Each TPGS and berberine reference powder capsules contains 400 mg berberine. Each Quillaja extract capsule contains 200 mg berberine. The total amount of berberine throughout is 800 mg.

After an 8-10 hour overnight fast, Group B will receive four soft capsules of Quillaja extract emulsified berberine (400mg). Following a 7 day wash out period, Group B participants will then receive two hard shell capsules of the berberine reference powder (400mg). Following another 7 day wash out period, Group B participants will then receive two soft gel capsules of TPGS emulsified berberine (400mg). Each TPGS and berberine reference powder capsules contains 400 mg berberine. Each Quillaja extract capsule contains 200mg berberine. The total amount of berberine throughout is 800 mg.

After an 8-10 hour overnight fast, Group C will receive two hard shell capsules of the berberine reference powder (400mg). Following a 7 day wash out period, Group C participants will then receive two soft gel capsules of TPGS emulsified berberine (400mg). Following another 7 day wash out period, Group C participants will then receive four capsules of the Quillaja extract emulsified berberine (200mg). Each TPGS and berberine reference powder capsules contains 400 mg berberine. Each Quillaja extract capsule contains 200mg berberine. The total amount of berberine throughout is 800 mg.

Healthy

Two capsules of berberine. Each capsule contains 400 mg berberine. The total amount of berberine throughout is 800 mg.

Berberine

Two capsules of TPGS/Quillaja extract emulsified berberine. Each capsule contains 400 mg berberine. The total amount of berberine throughout is 800 mg.

TPGS emulsified berberine

Four capsules of Quillaja extract emulsified berberine. Each capsule contains 200 mg berberine. The total amount of berberine throughout is 800 mg.

Quillaja extract emulsified berberine

Food Science and human nutrition department at University of Florida

The Absorption of Bioactive Berberine in Human

To Test the Efficacy of Novel Berberine Emulsification by TPGS or Quillaja Extract on the Absorption of Berberine Compared to Berberine Powder in Humans

To determine change in bioavailability of orally ingested berberine in human volunteers by increasing the area under the concentration-time curve (AUC).

To determine change in bioavailability of orally ingested berberine in human volunteers by increasing its plasma concentration peak concentration (Cmax).

To determine change in bioavailability of orally ingested berberine in human volunteers by increasing its the time point of maximum plasma concentration (Tmax).

To determine change in berberine metabolites concentrations.

University of Florida

Florida High Tech Corridor Council

Designs for Health, Inc.

Healthy donors age and sex matched to the patients

Rheumatoid Arthritis

Patients that started DMARD therapy after the Baseline collection

Rheumatoid Arthritis With DMARDs

RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker

Rheumatoid Arthritis Baseline for TNF-blockers

RA patients recruited at least 6 months after the start of a TNF-blocker

Rheumatoid Arthritis With TNF-blockers

Ankylosing Spondylitis

Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration

Ankylosing Spondylitis Baseline for TNF Blocker

Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.

Ankylosing Spondylitis With TNF-blockers

Controls

Total

Sex: Female, Male

DAS28 for RA. 28 joints included. tender and swollen joint count (TEN28, SWO28). Erythrocyte sedimentation rate (ESR) is measured. The patient makes a subjective assessment (SA) of disease activity.
DAS28 ≤ 3.2 Inactive > 3.2 but ≤ 5.1 Moderate > 5.1 Very active
ASDAS for AS. Combines five disease activity variables in one single score
ASDAS
≤ 3.1Inactive > 3.1 but ≤ 2.1 Moderate > 2.1 but ≤ 3.5 Moderate > 3.5 Very active

Disease activity

ESR (mm/hr)

CRP (mg/dl)

Symptoms duration (years)

Osteoclasts will be differentiated from untreated patients and patients under several TNF blockers.

Osteoclast Differentiation Ex-vivo

Total area resorbed by osteoclasts as percentage of total area analyzed

Osteoclast Activity Ex-vivo

Overall Study

João Eurico Fonseca

Healthy donors age and sex matched to the patients - Healthy donors were not under any therapy therefore they were not at risk and Adverse effects were not assessed.

Bone Resorption

Instituto de Medicina Molecular

Differences in Bone Cell Activity Between Rheumatoid Arthritis and Ankylosing Spondylitis

Joao Eurico Cortez Cabral da Fonseca

MD PhD

Instituto de Medicina Molecular João Lobo Antunes

Merck Sharp & Dohme Corp.

Normal Physiology

National Cancer Institute (NCI), 9000 Rockville Pike

Reproducibility of a Fecal Occult Blood Test Device for Gut Microbiota Analyses

National Cancer Institute (NCI)

Gingivitis

Patients enrolled in the study will be given 1, 2, 3 or 4 patches in a cycle by the order they enter the study.

periopatch

Jerusalem Perio Center

Effect of Herbal Extracts on Gingival Inflammation

The Effect of Herbal Extracts on Inflammatory Enzymes in the Gingiva: a Dose Finding Study.

Menachem Oberbaum, MD

Shaare Zedek Medical Center

Patients undergoing pancreaticoduodenectomy for pancreatic or peri-ampullary tumours.

Pancreatic Neoplasms

Adenocarcinoma

Neoplasm Circulating Cells

Tumor Markers, Biological

Monitoring, Immunologic

PD is a standard therapeutic surgical procedure. No additional interventions are performed.

beta glucuronidase/enflamasyon

The Absorption of Bioactive Berberine in Human

Differences in Bone Cell Activity Between Rheumatoid Arthritis and Ankylosing Spondylitis

Reproducibility of a Fecal Occult Blood Test Device for Gut Microbiota Analyses

Effect of Herbal Extracts on Gingival Inflammation

Perioperative Cancer Cell Dissemination and Systemic Immune Suppression in Resectable Ductal Pancreatic Adenocarcinoma

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