Proof of concept study to investigate bioavailability of two different Curcumin formulations in healthy subjects: a randomized, controlled, cross-over study
- Conditions
- Healthy subjects
- Registration Number
- DRKS00026962
- Lead Sponsor
- nternehmen zur Herstellung und Vertrieb von Nahrungsergänzungsmitteln
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 6
Healthy men and women
- BMI: 19 - 30 kg/m2
- Non-smoker
- Written consent to participate in the study
- Able and willing to follow the study procedure
Main exclusion criteria:
- Relevant history or presence of any severe medical disorder, potentially interfering with this study
- Known allergy and hypersensitivity to ingredients of the study product
- Blood donation within 1 month prior to study start or during study
- Significant changes in lifestyle or medication (within last 3 months) or surgical intervention or surgical procedure such as bariatric surgery
- For this study clinically relevant abnormal laboratory, vital signs or physical findings at screening
- Extreme dietary regimes”: vegan lifestyle, weight loss diet with <1200 kcal/day for women and <1800 kcal for men
- Regular intake of drugs or supplements possibly interfering with this study within 2 weeks prior to study start or during the study (e.g. curcumin)
- Chronic intake of substances affecting blood coagulation, which in the investigator’s opinion would impact subject safety
- Subjects with history of drug, alcohol or other substance abuse, or other factors limiting their ability to co-operate during the study.
- Known pregnancy, breast feeding or intention to become pregnant during the study.
- Anticipating any planned changes in lifestyle for the duration of the study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method From concentration-time curve of total curcuminoids over a time period of 0-8h the area under the curve will be determined. Comparison of AUC between study products.
- Secondary Outcome Measures
Name Time Method Comparison of Cmax and Tmax between study products.