Status:
COMPLETED
Clinical Study to Investigate the Effects of a Food Supplement Santa Herba Extract on Weight Loss in Overweight Women
Lead Sponsor:
Mibelle AG
Conditions:
Weight Loss
Eligibility:
FEMALE
25-60 years
Phase:
NA
Brief Summary
Aim of the study is to investigate the effect of a 12-week supplementation of Santa Herba Extract on body weight in overweight and obese subjects. Additionally appetite related marker as well as marke...
Eligibility Criteria
Inclusion
- Subject is able and willing to follow the study protocol procedures to sign the Informed Consent Form prior to screening evaluations
- Overweight and obese women with BMI 25 - 35 kg/m2 (limits included)
- Age: 25 - 60 years
- Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, haematology
Exclusion
- Relevant history or presence of any medical disorder potentially interfering with this study (heavy depression, diabetes, active cancer, severe liver disease, heavy cardiovascular diseases (e.g. stroke, heart attack))
- Chronic intake of medication/dietary supplements with impact on body weight or body composition or lipid modifying products (e.g. protein shakes, statins, omega-3 fatty acids, etc.) 2 months prior to screening or during the study; stable doses of e.g. hypertensive therapy and thyroid gland hormones are acceptable.
- Change in hormonal contraceptive during or at least 3 months before the study
- Consumption of any dietary supplement / fortified food (with exception of vitamin D and mineral supplements e.g. Ca, Mg)
- Low body fat mass measured at screening with BIA ( bioelectrical impedance analysis ) (Cut off-value: \<36% body fat).
- Weight loss intervention or recent body weight change \> 4.5 kg during last 3 months
- Diet high in vegetables and fruits ≥ 5 portions per day
- Vegan lifestyle
- Smoker \> 10 cigarettes / day
- Gastrointestinal diseases/conditions (colitis ulcerosa, Crohn's disease, peptic ulcers, celiac disease)
Key Trial Info
Start Date :
February 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03853603
Start Date
February 15 2019
End Date
August 12 2019
Last Update
August 14 2019
Active Locations (1)
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1
BioTeSys GmbH
Esslingen am Neckar, Germany, 73728