DRKS00010789
Completed
未知
Investigation of anti-inflammatory and anti-oxidative properties of curcumin in overweight subjects: a randomized, double-blind, placebo-controlled study - BTS965/16
ConditionsObese volunteers
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Obese volunteers
- Sponsor
- Wacker Chemie AG
- Enrollment
- 61
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age: between 35 and 70 years
- •Overweight and obese men and women
- •Subjects having a body mass index (BMI) between 28 and 40 kg/m²
- •Body fat: Women: \= 36%, Men \= 23% (assessed with BIA)
- •Non\-smoker
- •Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
- •Subject is able to communicate well with the Investigator, to understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the Investigator
- •Not anticipating any planned changes in lifestyle regarding activity and nutrition for the duration of the study
- •Subject is in good physical and mental health as established by medical history, physical exami\-nation, electrocardiogram, vital signs.
- •Have clinically normal findings for haematology and clinical chemistry (or clinically insignificant, if value is outside of the normal range)
Exclusion Criteria
- •History or presence of significant cardiovascular disease or co\-morbidities (e.g., stroke, diabetes etc.)
- •Known allergy to ingredients of study preparation
- •Present or recent use of drugs and dietary supplements with anti\-inflammatory properties that could interfere with the study 2 months before or during the study (e.g. Curcumin, omega\-3 FA, chronic intake of NSAR, ibuprofen, glucocorticoids (except inhalative) etc.), vitamin use (e.g. vi\-tamin C, vitamin E) or further antioxidative or mineral supplements (e.g. Mg, Ca, OPC etc.).
- •Chronic intake of lipid/glucose modifying agents (e.g. statines, phytosterines, metformin, insulin)
- •Female patients that are pregnant or nursing
- •Fat malabsorption (Crohn’s or celiac disease, cystic fibrosis)
- •Gastrointestinal diseases/conditions (colitis ulcerosa, Crohn’s IBS, IBD, peptic ulcers, celiac, reflux disease)
- •Gall bladder resection
- •Chronic intake of proton pump inhibitors
- •Chronic intake of substances affecting blood coagulation (e.g. acetylic acid, anticoagulants, diuretics, thiazides), which in the investigator’s opinion would impact volunteer safety
Outcomes
Primary Outcomes
Not specified
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