Participant receives both curcumin and prednisolone. Curcumin for 11 days, prednisolone for 10 days. Curcumin: 2 tablets (each contains 100 mg curcumin) twice daily. Prednisolon: 50 mg (capsule) every morning

Participant receives prednisolone and curcumin-placebo. Curcumin-placebo for 11 days, prednisolone for 10 days. Curcumin-placebo: 2 tablets twice daily. Prednisolon: 50 mg (capsule) every morning

Participant receives prednisolone.placebo and curcumin-placebo. Curcumin-placebo for 11 days, prednisolone-placebo for 10 days. Curcumin-placebo: 2 tablets twice daily. Prednisolon-placebo: One capsule every morning.

Insulin Resistance

Non-Alcoholic Fatty Liver Disease

Curcumin is given together with prednisolone

Curcumin Liposome

Prednisolone is given together with curcumin-placebo

Prednisolone

Prednisolone-placebo is given together with curcumin-placebo

Placebos

Center for Clinical Metabolic Research

The Effect of Curcumin on the Development of Prednisolone-induced Hepatic Insulin Resistance

The Effect of Curcumin on the Development of Prednisolone-induced Hepatic Insulin Resistance in Overweight and Obese Participants

homeostatic model assessment of insulin resistance is calculated before and after intervention

Measured by MR spectroscopy of the liver (unit: %)

Estimated by collecting urin for 4-5 hours, measuring volume of urine and urea concentration

Feces sample before and after intervention

subcutaneously, interstitial measurement (concentration of glucose) every 15 minutes in the intervention period

icare 100 tonometer measurement (unit: mmHg)

measured by bioimpedance (units: kg and %)

MR-spectroscopy measurement (unit: cm3 at L3-level, 1 cm thick slice)

visual analogue scale evaluation (no visible numbers/points, just a clear line)

Evaluated by calculating ingested meal at ad libitum meal at test days (unit: grams and calories)

Visual analogue scale (no points/number visible, just a clear line)

Pernille Høgh Hellmann

Medical Doctor, primary investigator

University Hospital, Gentofte, Copenhagen

After study day 1, participants are randomized (1:1:1) to one of three treatments: 1) Prednisolon and Curcumin, 2) Prednisolon and placebo or 3) Placebo and placebo.

Three 30 mg capsules once daily, self-administered for 6 months.
Curcumin is a nutraceutical, which are products isolated or purified from foods. The rhizomes of the plant Curcuma longa produces turmeric, a spice commonly used in Indian cuisine. Turmeric is comprised of three curcuminoids, of which curcumin is the most abundant. Curcumin is a polyphenol molecule that has been investigated for anti-inflammatory and anti-neoplastic properties since the 1970s.

Three 30 mg capsules taken once daily, self-administered for 6 months.
Placebo capsules are identical to the curcumin capsules in color, taste, smell, size and shape.

Chronic Kidney Disease

Micro-particle Curcumin

Looks, smells, tastes and feels exactly like the Curcumin capsules.

Placebo

Population Health Research Institute

Kidney Clinical Care Unit

University Hospital

Victoria Hospital

Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease

Albuminuria will be measured using urinary albumin-to-creatinine ratio from first morning urine samples. At each visit (pre-randomization, and 3- and 6-months post-randomization), urinary albumin-to-creatinine ratio is measured on two consecutive days and the average of the two values will be computed. The average of the two values will be log-transformed using the natural logarithm. Albuminuria is the cardinal manifestation of a malfunctioning filtration barrier and the spillage of albumin into renal tubules is thought to be toxic to tubular cells, resulting in further kidney damage. Therefore, in the current understanding, albuminuria is both a marker and a mediator of kidney damage. Reduction of albuminuria has repeatedly been associated with improved renal outcomes. Leaders in the field of nephrology recommend that albuminuria be used as a valuable predictor of response to therapy for the prevention of kidney failure.

eGFR will be calculated using the CKD-EPI formula. The investigators will estimate the between-group difference in change in eGFR (6-month eGFR minus baseline eGFR), expressed in mL/min per 1.73m2, using linear regression.

The investigators will summarize the percentage of glycated hemoglobin pre-randomization and 6-months post-randomization and will present the between-group difference in change in percentage of glycated hemoglobin (6-month value minus pre-randomization value) among patients with diabetes mellitus.

The investigators will report on the outcome of progressive CKD, ESRD, and death, first as a composite outcome, and then as separate components. ESRD will be defined as an eGFR <15 mL/min/1.73 m2 or the initiation of renal replacement therapy, which includes chronic dialysis or transplantation; progressive CKD will be defined as an eGFR loss of ≥ 30% (anytime during follow-up from the pre-randomization baseline value) or ESRD. Less than 10% of participants will be expected to experience these outcomes by 6 months. The focus of this analysis is to document any trends to inform the expected event rate for future studies.

Health-related quality of life scores will be determined by the RAND version of the 36-Item Short Form Health Survey (SF-36) administered pre-randomization and at 3-months and 6-months post-randomization. The physical composite summary (PCS) score of the SF-36 will be examined. The between-group difference in change in score, 6-month value minus pre-randomization value, will be reported with 95% CIs.

Health-related quality of life scores will be determined by the RAND version of the 36-Item Short Form Health Survey (SF-36) administered pre-randomization and at 3-months and 6-months post-randomization. The mental composite summary (MCS) score of the SF-36 will be examined. The between-group difference in change in score, 6-month value minus pre-randomization value, will be reported with 95% CIs.

To confirm our micro-particle curcumin was bioavailable, and to strengthen any relationship between micro-particle curcumin and any outcomes identified, serum levels of curcumin and its major metabolites will be measured in the first 30 participants 3 months after randomization (including patients taking micro-particle curcumin and those taking placebo). Serum curcumin and its major metabolites will be summarized in the first 30 participants randomized, by group. The between-group difference in average serum curcumin levels measured 3-months post-randomization will be reported with the 95% CI.

The investigators will conduct an exploratory subgroup analysis based on a higher or lower estimated risk of kidney failure, using the kidney failure risk equation. Participants with a 2-year risk of ESRD less than 10% will be classified as lower risk, and patients with a risk of 10% or more will be classified as higher risk.

Matthew Weir

Nephrologist, MD, FRCPC, MSc

Lawson Health Research Institute

The Kidney Foundation of Canada

Canadian Institutes of Health Research (CIHR)

Coltect contains natural compounds: curcumin, green tea and selenium which are approved as food supplements by the Ministry of Health in Israel. Curcumin and green tea are widely used in the food industry.

Ulcerative Colitis

Two tablets twice daily (BID) during the 2 months of the study. Each tablet contains 500mg Curcumin, 250mg Green tea and 100mcg Selenomethionine.

Coltect

Tel-Aviv Sourasky Medical Center

The Efficacy and Tolerability of Coltect as Add-on in Patients With Active Ulcerative Colitis - an Open Label

Dr. Iris Dotan

mouth wash with curcumol and mouth wash with chlorexidin

Chemotherapy Induced Mucositis

Mouth wash with chlorehexidin, three times a day

Mouth wash

5 ml in 50 ml water, mouthwash for 30 seconds, three times a day

curcumin/übelkeit

The Effect of Curcumin on the Development of Prednisolone-induced Hepatic Insulin Resistance

Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease

The Efficacy and Tolerability of Coltect as Add-on in Patients With Active Ulcerative Colitis - an Open Label

Curcumin for Prevention of Oral Mucositis in Children Chemotherapy

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