200mls smoothie without EPA or DHA. Looks and tastes identical to omega-3 arm

Bipolar Depression

Smoothie 1g Eicosapentaneoic Acid (EPA) and 1g Docoshaexanoic Acid (DHA)

NUI Galway

A Prophylactic Trial of Omega-3 Polyunsaturated Fatty Acids in Bipolar Disorder

Documented episodes of depression or elation noted in clinical notes, or re-hospitalisation or treatment change secondary to episode of depression or elation

Change from baseline in psychometric instruments

Presence of adverse effects secondary to intervention or placebo

Study engagement rates between intervention and placebo arms

Dr. Brian Hallahan

Senior Lecturer

National University of Ireland, Galway, Ireland

Stanley Medical Research Institute

One month placebo run in prior to randomisation

Diabetic foot routine treatment without intervention

On the basis of routine treatment of diabetic foot, adipose stem cells will be added to treat diabetic foot

Diabetes Mellitus Foot Ulcer

intramuscular injection of adipose stem cells treat diabetic foot

MSCs treatment

Clinical Study of Adipose-derived Stem Cells in the Treatment of Diabetic Foot

Ulcer healing rate = number of cases of complete wound healing / total number of ulcers in this group

Amputation rate = number of amputations / total number of amputations in this group

Evaluate patients' limbs blood flow by ultrasound，We will record blood flow velocities, for example， 4ml/second.

The ratio of ankle artery pressure to brachial artery pressure was obtained by measuring the contractile pressure of the posterior tibial artery, anterior tibial artery and brachial artery of the ankle.ABI≥0.9 means normal,0.8≥ABI≥0.7means mild arterial obstruction,0.6≥ABI≥0.4means moderate arterial obstruction,ABI＜0.4means severe arterial obstruction.

Evaluate patients'oxygen level by TcPO2,TcPO2＜20mmHg means very severe lesion.

Evaluate patients' limbs blood flow by CTA,We will record blood flow velocities, for example， 4ml/second.

Evaluate patients' limbs blood flow by Rutherford classification，Grade 0: Normal Grade 1: Walking over 500 meters with lameness Grade 2: Walking 200-500 meters with lameness Grade 3: Walking within 200 meters with lameness Grade 4: Resting pain Grade 5: Small ulcer Grade 6: Large ulcer.

Evaluate patients' degree of pain by Wong-Baker Faces Pain Rating Scale.There are 6 faces in the Wong-Baker Pain Scale. The first face represents a pain score of 0, and indicates "no hurt". The second face represents a pain score of 2, and indicates "hurts a little bit." The third face represents a pain score of 4, and indicates "hurts a little more". The fourth face represents a pain score of 6, and indicates "hurts even more". The fifth face represents a pain score of 8, and indicates "hurts a whole lot"; the sixth face represents a pain score of 10, and indicates "hurts worst.

Maoquan Li

Prof. Dr. Li

Soybean oil placebo capsules, 4 capsules daily for 12 weeks

Eicosapentaenoic acid (EPA) 1000 mg capsules, 1 daily (plus 3 placebo capsules) for 12 weeks

Eicosapentaenoic acid (EPA) 1000 mg capsules, 2 daily (plus 2 placebo capsules) for 12 weeks

Eicosapentaenoic acid (EPA) 1000 mg capsules, 4 daily for 12 weeks

Soybean oil placebo capsules, 4 capsules daily for 12 weeks
Placebo: Soybean oil placebo

Placebo

Eicosapentaenoic acid (EPA) 1000 mg capsules, 1 daily (plus 3 placebo capsules) for 12 weeks
Placebo: Soybean oil placebo
EPA 1 g/day: Omega-3 fatty acid extracted from fish oil, 1 g/day

EPA 1 g/Day

Eicosapentaenoic acid (EPA) 1000 mg capsules, 2 daily (plus 2 placebo capsules) for 12 weeks
Placebo: Soybean oil placebo
EPA 2 g/day: Omega-3 fatty acid extracted from fish oil, 2 g/day

EPA 2 g/Day

Eicosapentaenoic acid (EPA) 1000 mg capsules, 4 daily for 12 weeks
EPA 4 g/day: Omega-3 fatty acid extracted from fish oil, 4 g/day

EPA 4 g/Day

Total

Sex: Female, Male

Race/Ethnicity, Customized

Region of Enrollment

To evaluate whether a dose-response relationship exists between dose of EPA and decrease either in plasma interleukin-6 (IL-6) levels (pg/mL) or in mitogen-stimulated peripheral blood mononuclear cell (PBMC) Tumor Necrosis Factor-α (TNF-α) expression and secretion (pg/mL), when compared with placebo. Levels of inflammatory biomarkers were assessed at baseline (week 0) and at week 12 for comparison. Percent changes were calculated as relative to baseline values. Greater percent decrease indicates better outcome.

Percent Change in Plasma Concentration of Inflammatory Biomarkers IL-6 (pg/mL) and PBMC TNF-α (pg/mL)

To evaluate whether EPA treatment produces a decrease in ratings of depression severity after 12 weeks of treatment, when compared with placebo-treated subjects. Comparison is made between pre-treatment and post-12 weeks treatment. Inventory of Depressive Symptomatology-30 item-Clinician Rated (IDS-C30) is a depression severity scale, where lower scores indicate less depressive severity and higher scores indicate greater severity. Minimum score is 0 (zero) and maximum score is 84.

Mean Change in Depression Severity Score (IDS-C30) After 12 Weeks of Treatment

To evaluate whether EPA treatment produces a decrease in ratings of depression severity, when compared with placebo-treated subjects; and whether the changes in IL-6 or mitogen- stimulated PBMC TNF-α expression will mediate changes observed in ratings of depression.
Inventory of Depressive Symptomatology-30 item-Clinician Rated (IDS-C30) is a depression severity scale, where lower scores indicate less depressive severity and higher scores indicate greater severity. Minimum score is 0 (zero) and maximum score is 84. Change in score over 12 weeks (from week 0 to week12) is calculated as a percent change from baseline. Greater percent change in the negative direction indicates better outcome.

Percent Change in IDS-C Score After 12 Weeks of Treatment

To evaluate whether EPA treatment produces decreases in plasma levels of mitogen-stimulated PBMC IL-6 and TNF-α (both in in pg/mL). Percent change calculated by comparing week 12 to week 0 (baseline). Greater decrease (change in negative direction) indicates better outcome.

Percent Change in Plasma Concentrations of Mitogen-stimulated PBMC IL-6 (pg/mL) and Plasma Tumor Necrosis Factor (TNF)-α (pg/mL)

To evaluate whether EPA treatment produces decreases in the expression of inflammation pathway-related genes for IL-6 and TNF-α (in ΔΔCt units). Levels compared at week 0 (baseline) and at week 12 to obtain percent change from baseline. Greater decrease (change in negative direction) indicates better outcome.

Percent Changes in Levels of Expression of Inflammation-related Genes for Interleukin (IL)-6 and Tumor Necrosis Factor (TNF)-α (in ΔΔCt Units)

To evaluate whether EPA treatment produces decreases in plasma hs-CRP in mg/L. Levels compared at week o (baseline) and week 12 to obtain percent change. Greater percent decrease in the negative direction indicates better outcome.

Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) in mg/L

Overall Study

Dr David Mischoulon, Director, Depression Clinical and Research Program, MGH

Major Depressive Disorder

Overweight

Inflammation

Omega-3 fatty acid extracted from fish oil, 1 g/day

EPA 1 g/day

Omega-3 fatty acid extracted from fish oil, 2 g/day

EPA 2 g/day

Omega-3 fatty acid extracted from fish oil, 4 g/day

EPA 4 g/day

Emory University School of Medicine

Depression Clinical and Research Program at Massachusetts General Hospital

Omega-3 Fatty Acids for Major Depressive Disorder With High Inflammation: A Personalized Approach

Omega-3 Fatty Acids for MDD With High Inflammation: A Personalized Approach

David Mischoulon, MD, PhD

Principal Investigator

Massachusetts General Hospital

Emory University

Study compared 3 dosing regimens of eicosapentaenoic acid (EPA), 1 g/day, 2 g/day, and 4 g/day versus an inactive placebo.

All the above were blinded to the interventions. Placebo and EPA capsules had identical appearances.

psychomotor agitation/necrose

A Prophylactic Trial of Omega-3 Polyunsaturated Fatty Acids in Bipolar Disorder

Clinical Study of Adipose-derived Stem Cells in the Treatment of Diabetic Foot

Omega-3 Fatty Acids for Major Depressive Disorder With High Inflammation: A Personalized Approach

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