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.

30 subjects will be randomized under active arm and will receive Active Product at V1 and until V2 (5 weeks of treatment).

30 subjects will be randomized under Placebo arm and will receive placebo Product at V1 and until V2 (5 weeks of treatment).

Gastrointestinal Tolerance

Liver Function

Kidney Function

30 subjects will take 1000mg in 4 capsules (with 250ml water before breakfast , each day, during 5 weeks

Turmipure Gold™

30 subjects will take 4 capsules with 250ml water before breakfast , each day, during 5 weeks

Placebo

Biofortis Mérieux NutriSciences

A Clinical Trial to Evaluate the Chronic Safety and Tolerance of Turmipure Gold™ in Healthy Subjects

A Double-blind Placebo-controlled Clinical Trial to Evaluate the Chronic Safety and Tolerance of Turmipure Gold™ in Healthy Subjects

The primary endpoint in this study is the composite score of gastrointestinal tolerance (Bristol stool chart and Lickert scale) after 5 weeks of supplementation +/- 3 days (a.u./day, range 0-50), expressed in a.u
This composite score will be defined as the sum of the ratings of GI symptoms scores and the composite score of stool frequency and consistency (36):
Composite GI symptoms tolerance = Bloating score + Abdominal cramping score + Stomach noises score + Flatulence score + Stool score*

Bristol Stool chart is used - this scale allows to measure to evaluate stool frequency and consistency. The Bristol Stool Chart or Bristol Stool Scale is a medical aid designed to classify faeces into seven groups. The Bristol Stool Chart shows seven categories of stool:
Type 1-2 indicate constipation Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhoea and urgency.

Lickert scale was used to evaluate gastro-intestinal symptoms. The gastro-intestinal symptoms will be reported during 3 days before V1 visit. A mean of these 3 days will be calculated. Each GI symptom will be given a score of 0 (no symptoms) to 10 (severe symptoms).
This scale allow to have four scores :
Bloating score (a.u./day, range 0-10),
Abdominal cramping score (a.u./day, range 0-10),
Stomach noises score (= Borborygmi) (a.u./day, range 0-10),
Flatulence score (a.u./day, range 0-10), These scores will be combined to evaluate the gestointestinal symptoms

The GastoIntestinal quality of Life (GIQLI) questionnaire is composed of 36 items. The responses for each item are scored from 0 to 4, from the worst to the best rating. Example of answers to question 1: always (0), most of the time (1), sometimes (2), rarely (3), never (4).
The average overall score for each subject and visit will be calculated by summing the scores of each question divided by 144 and multiplied by 100 (average overall score reduced to a score between 0 and 100; the maximum score being 100) (Slim et al., 1999).
The items focus on 5 subscales (Slim et al., 1999):
Symptoms (19 items): items 1 to 9 and 27 to 36 (theoretical score range: 0-76),
Fitness (7 items): items 15 to 21 (theoretical score range : 0-28),
Emotions (5 items): items 10 to 14 (theoretical score range: 0-20),
Social integration (4 items): items 22, 23, 25 and 26 (theoretical scope range: 0-16),
The effect of possible medical treatment (1 item): item 24 (theoretical score range: 0-4).

This diary will be filled by subjects the week before V1 visit and the data will be collected and analyzed by a dietician.
This diary will allow to evaluate food intake :
total energy intake (kcal),
percentage of energy intake from proteins (%),
percentage of energy intake from fat (%),
percentage of energy intake from carbohydrates (%),
dietary fiber (g) and hydric intake,
These data will be combined to evaluate the food intake

This diary will be filled by subjects the week before V2 visit and the data will be collected and analyzed by a dietician.
This diary will allow to evaluate food intake :
total energy intake (kcal),
percentage of energy intake from proteins (%),
percentage of energy intake from fat (%),
percentage of energy intake from carbohydrates (%),
dietary fiber (g) and hydric intake,
These data will be combined to evaluate the food intake

This self-administered questionnaire IPAQ will be filled by subjects at V1 visit. For each subject and visit, the total metabolic equivalent will be calculated from the IPAQ questionnaire short form.
This continuous score, expressed as MET-min per week (MET level x Number of minutes of activity/day x Number of days per week), will be calculated using the following formula (Guideline IPAQ, 2005):
Total MET-minutes/week = Walking (METs*min*days) + Moderate intensity (METs*min*days) + Vigorous intensity (METs*min*days) with: . Walking = 3.3 METs;
Moderate Intensity = 4.0 METs;
Vigorous Intensity = 8.0 METs.

This self-administered questionnaire IPAQ will be filled by subjects at V2 visit. For each subject and visit, the total metabolic equivalent will be calculated from the IPAQ questionnaire short form.
This continuous score, expressed as MET-min per week (MET level x Number of minutes of activity/day x Number of days per week), will be calculated using the following formula (Guideline IPAQ, 2005):
Total MET-minutes/week = Walking (METs*min*days) + Moderate intensity (METs*min*days) + Vigorous intensity (METs*min*days) with: . Walking = 3.3 METs;
Moderate Intensity = 4.0 METs;
Vigorous Intensity = 8.0 METs

Naturex SA

BioFortis

This pharmacokinetic study is designed as a monocentric, randomized, parallel arms, double-blind, placebo-controlled clinical trial.
Three visits planned: a screening visit (V0) for subjects selection, a randomization visit (V1 with product dispensation, 2 weeks after V0) and a end-of-study visit (V2, 5 weeks after V1). between V1 and V2, a telephone interview will be organized with each subject to evoke the tolerance of the product at mid-term.
An additional end-of-study visit could be planned if the biological results of the V2 visit are not satisfactory, according to the opinion of the investigator.

subject allocation sequence 1. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order.

subject allocation sequence 2. IIntervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order.

subject allocation sequence 3. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order.

subject allocation sequence 4. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order.

subject allocation sequence 5. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order.

subject allocation sequence 6. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order.

subject allocation sequence 7. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order.

subject allocation sequence 8. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order.

subject allocation sequence 9. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order.

subject allocation sequence 10. Intervention: The subject will receive the five products (TG, STE, NOV, PHYT or TEP) in a certain order.

Healthy

Turmipure GOLD™ 30% curcuminoids (300 mg)

Standard turmeric powder extract 95% curcuminoids (1500 mg)

Novasol® Liquid micellar formulation 6% curcuminoids (1000 mg)

Meriva® Turmeric Phytosome formulation 20% curcuminoids (1000 mg)

PHYT

Turmeric extract C3 complex® 95% curcuminoids (1500mg) + BioPerine® 95% piperine (15 mg)

A Comparative Pharmacokinetic Study to Evaluate the Ability of a New Formulation to Enhance Curcuminoids Bioavailability

A Comparative Pharmacokinetic Study in Healthy Volunteers to Evaluate the Ability of TURMIPURE GOLD Formulation to Enhance the Bioavailability of Curcuminoids

The primary endpoint is the dose-normalized AUC of total curcuminoids (sum of curcumin, DMC, BDMC and their metabolites) plasmatic concentration from 0 to 24 hours (AUC0-24h/dose) (expressed in µg.h/mL/mg). The dose-normalized AUC is the AUC normalized to curcuminoids intake by dividing the observed AUC by the corresponding curcuminoids dosage of each administration The following time-points are considered: T0, T15, T30, T45, T60, T90, T120, T240, T60, T480, T24H. T-10 will be considered as baseline value (T0) for AUC calculation. The primary comparison is Turmipure Gold 300 mg vs Standard turmeric 1500 mg powder extract.

AUC of total curcuminoids plasmatic concentration from 0 to 24 hours (AUC0-24h, expressed in µg.h/mL);

AUC of curcuminoids separately (curcumin, DMC, BDMC) plasmatic concentrations from 0 to 24 hours (AUC0-24h, expressed in µg.h/mL);

AUC of curcuminoids metabolites plasmatic concentrations from 0 to 24 hours (AUC0-24h, expressed in µg.h/mL);

AUC of total curcuminoids plasmatic concentration from 0 to 8 hours normalized to curcuminoids intake (AUC0-8h/dose, expressed in µg.h/mL/mg);

AUC of total curcuminoids plasmatic concentration from 0 to 8 hours (AUC0-8h) (expressed in µg.h/mL);

AUC of curcuminoids separately (curcumin, DMC, BDMC) plasmatic concentrations from 0 to 8 hours (AUC0-8h, expressed in µg.h/mL);

AUC of curcuminoids metabolites plasmatic concentrations from 0 to 8 hours (AUC0-8h, expressed in µg.h/mL);

AUC of total curcuminoids plasmatic concentration from 0 to infinity normalized to curcuminoids intake (AUC0-infinity/dose, expressed in µg.h/mL/mg);

AUC of total curcuminoids plasmatic concentration from 0 to infinity (AUC0-infinity, expressed in µg.h/mL);

AUC of curcuminoids separately (curcumin, DMC, BDMC) plasmatic concentrations from 0 to infinity (AUC0-infinity, expressed in µg.h/mL);

AUC of curcuminoidsmetabolites plasmatic concentrations from 0 to infinity (AUC0-infinity, expressed in µg.h/mL);

Peak of total curcuminoids plasmatic concentration normalized to curcuminoids intake (Cmax/dose, expressed in µg/mL/mg);

Peak of total curcuminoids plasmatic concentration (Cmax, expressed in µg/mL);

Peak of curcuminoids separately plasmatic concentrations (Cmax, expressed in µg/mL);

Peak of curcuminoids metabolites plasmatic concentrations (Cmax, expressed in µg/mL);

Half-life of total curcuminoids in plasma (t1/2, expressed in minutes);

Half-life of curcuminoids separately (curcumin, DMC, BDMC) in plasma (t1/2, expressed in minutes);

Half-life of curcuminoids metabolites in plasma (t1/2, expressed in minutes);

Terminal elimination rate constant of total curcuminoids in plasma (λz);

Terminal elimination rate constant curcuminoids separately (curcumin, DMC, BDMC) in plasma (λz);

Terminal elimination rate constant curcuminoids metabolites in plasma (λz);

Time to peak of total curcuminoids plasmatic concentration in plasma (Tmax, expressed in minutes)

Time to peak of plasmatic concentrations curcuminoids separately (curcumin, DMC, BDMC) in plasma (Tmax, expressed in minutes);

Time to peak of plasmatic concentrations curcuminoids metabolites in plasma (Tmax, expressed in minutes);

Relative bioavailability from 0 to 24 hours defined as the ratio of dose-normalized AUC0-24h of total curcuminoids for the different tested formulation to the dose-normalized AUC0-24h obtained for the reference product (turmeric extract 95% curcuminoids).

This pharmacokinectic study is designed as a monocentric, randomized, cross-over, pilot and open clinical trial

demethoxycurcumin/uždegimas

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

A Clinical Trial to Evaluate the Chronic Safety and Tolerance of Turmipure Gold™ in Healthy Subjects

A Comparative Pharmacokinetic Study to Evaluate the Ability of a New Formulation to Enhance Curcuminoids Bioavailability

A Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Curcuminoids in Oral Lichen Planus

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