NCT03853603CompletedNot Applicable
Clinical Study to Investigate the Effects of a Food Supplement With Santa Herba Extract on Weight Loss and Modulation of Appetite-related Biomarkers in Overweight Women - a Randomized, Placebo-controlled Parallel Study
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mibelle AG
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Body weight
Study Overview
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 marker of white adipose tissue browning will be evaluated.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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)
Arms & Interventions
Placebo
Placebo Comparator
Maltodextrin
Intervention: Placebo (Dietary Supplement)
Santa herba extract
Active Comparator
Santa herba extract
Intervention: Santa herba (Dietary Supplement)
Outcomes
Primary Outcomes
Body weight
Time Frame: day 85
electronic scale
Secondary Outcomes
- BCM/ECM index(Day 85)
- Concentration of lipid profile in serum(Day 85)
- Questionnaire about Appetite (AEBQ)(Day 85)
- Body fat (%)(Day 85)
- Waist-hip ratio (WHR)(Day 85)
- Sagittal abdominal diameter (SAD) [cm](Day 85)
- Concentration of Lipokin in plasma(Day 85)
Investigators
Study Sites (2)
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