Patients will be randomized at a ratio of 2:1, to hyperbaric chamber (100% oxygen at 2 ATA)

Patients will be randomized at a ratio of 2:1, to Sham chamber (21% oxygen at 1 ATA)

T1DM

HBOC group will receive 100% oxygen at 2 ATA for 90 min with 5 min air breaks every 20 min at each session. Intensive management period includes 60 daily sessions, 5 days per week within 12 weeks,

Hyperbaric oxygen chamber (HBOC)

sham Hyperbaric oxygen chamber (HBOC)

Efficacy of Hyperbaric Oxygen Therapy (HBOT) in New-onset Type-1 Diabetes Mellitus

Double Blind, Randomized Controlled Study to Evaluate the Efficacy of Hyperbaric Oxygen Therapy (HBOT) in New-onset Type-1 Diabetes Mellitus

Difference between treatment groups (HBOT/SHBC) in change of β cell function (measured by AUC of stimulated C peptide) from screening to end of study (52 weeks).

Difference between treatment groups (HBOT/SHBC) in change of β cell function (measured by C-max of stimulated C peptide) from screening to end of study (52 weeks).

Difference between groups in achievement of glycemic targets according to ITDD, with a lower ITDD. assessed by: mean and SD of glucose, CV, time spent in range >70%, and time spent at hypoglycemic range < 1% at end of treatment periods, IDD according to weight.

Assaf Harofeh MC

Head Pediatric Endocrinology Unit

Study participants whose drink formulation contains no active ingredients but will appear and taste similar to the two other formulations. This will form the control formulation

Study participants' drink formulation will include Red Yeast Rice 600mg, Niacin 12.5mg, Phytosterol esters 650mg, L-Carnitine 150mg, vitamin C 500mg, and Co-Q-10 25mg.

The third formulation will be identical to the second, but without the Red Yeast Rice.

Hyperlipidemia

Each subject will be expected to consume a twice daily drink of approximately 4 ounces per serving taken with the morning and evening meals for a total of 8 weeks. Each bottle will contain two servings.

Placebo

Second Formulation

Third Formulation

Mitchell Karl, M.D. -- Cardiology

A Study Of Nutraceutical Drinks For Cholesterol (Evaluating Effectiveness and Tolerability)

A Multicenter Study Of Nutraceutical Drinks For Cholesterol (Evaluating Effectiveness and Tolerability)

The primary end point will be relative LDL and total cholesterol reductions, i.e., the placebo subtracted reduction in these parameters.

Secondary end points will include change from the control formulation with regard to HDL.

Secondary end points will include change from the control formulation with regard to CRP.

Secondary end points will include change from the control formulation with regard to triglyceride levels.

niacin/seizures

Efficacy of Hyperbaric Oxygen Therapy (HBOT) in New-onset Type-1 Diabetes Mellitus

A Study Of Nutraceutical Drinks For Cholesterol (Evaluating Effectiveness and Tolerability)

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