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Clinical Trials/DRKS00010789
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

Wacker Chemie AG0 sites61 target enrollmentJuly 7, 2016

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.

Registry
who.int
Start Date
July 7, 2016
End Date
December 20, 2016
Last Updated
last year
Study Type
Interventional
Sex
All

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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