Clinical trial NCT03853603: Clinical Study to Investigate the Effects of a Food Supplement Santa Herba Extract on Weight Loss in Overweight Women
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Keywords: lipid profile
12,13-diHOME
Lead sponsor: Mibelle AG
Sponsor class: INDUSTRY
First posted: 2019-02-25
Enrollment: 50
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Body weight
timeFrame: day 85
Secondary outcomes:
measure: Body fat (%)
timeFrame: Day 85
measure: BCM/ECM index
timeFrame: Day 85
measure: Waist-hip ratio (WHR)
timeFrame: Day 85
measure: Sagittal abdominal diameter (SAD) [cm]
timeFrame: Day 85
measure: Concentration of lipid profile in serum
timeFrame: Day 85
measure: Concentration of Lipokin in plasma
timeFrame: Day 85
measure: Questionnaire about Appetite (AEBQ)
timeFrame: Day 85
Other outcomes:
Locations:
city: Esslingen
country: Germany
facility: BioTeSys GmbH
Study officials:
affiliation: BioTeSys GmbH
name: Daniel Menzel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Modinger Y, Schon C, Wilhelm M, Pickel C, Grothe T. A Food Supplement with Antioxidative Santa Herba Extract Modulates Energy Metabolism and Contributes to Weight Management. J Med Food. 2021 Nov;24(11):1235-1242. doi: 10.1089/jmf.2021.0016. Epub 2021 Jul 13.