Obese volunteers
Conditions
Interventions
Group 1: 2 g CAVACURMIN®: cyclodextrin inclusion complex of curcumin with gamma-Cyclodextrin
Equivalent to 360 mg Curcuminoides
Oral, 2x 3 capsules/day (morning and evening)
duration of intervention 12 weeks
Group 2: Placebo: 2 g Cellulose
Sponsors
Wacker Chemie AG
Eligibility
Sex/Gender
All
Age
35 Years to 70 Years
Inclusion 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
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 •Donation of blood within the previous 4 weeks before screening •Participation in a clinical trial with an investigational product within 4 weeks before screening •Known alcohol abuse or drug abuse •Known infection of human immunodeficiency virus (HIV) or hepatitis B or C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exploratory study: Analysis of the following blood parameters at baseline and after 3 months of intake-phase and comparison of changes with placebo: - levels of inflammatory proteins (TNF-alpha, IL-6, hsCRP) - Adiponectin - TOS (total oxidative status) - Lipid status (Cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides) - Glucose metabolism (HOMA-Index, HbA1c) | — |
Secondary
| Measure | Time frame |
|---|---|
| Additinal parameters: - BIA (body fat, ECM/BCM Index) - Waist-to-hip ratio (WHR) - SAD (sagittal abdominal diameter) - Global assessment, general health and quality of life (questionnaire) - Curcuminoides in plasma (optionally) | — |
Countries
Germany
Contacts
Public ContactJasmin Steudle
BioTeSys GmbH
Outcome results
None listed