Weight Loss
Conditions
Keywords
lipid profile, 12,13-diHOME
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.
Interventions
DIETARY_SUPPLEMENTSanta herba
Santa herba dry extract; 400 mg/day. 2 capsules/day; 1 capsule twice daily with the main meals (lunch and dinner)
DIETARY_SUPPLEMENTPlacebo
Maltodextrin; 400 mg/day. 2 capsules/day; 1 capsule twice daily with the main meals (lunch and dinner)
Sponsors
Mibelle AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 60 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | day 85 | electronic scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BCM/ECM index | Day 85 | Body cell mass (BCM) in kg and extracellular mass (ECM) in kg will be combined to report BCM/ECM index |
| Waist-hip ratio (WHR) | Day 85 | Waist circumference in centimetre (cm) and hip circumference in centimetre (cm) will be combined to report WHR in cm/cm |
| Sagittal abdominal diameter (SAD) [cm] | Day 85 | Sagittal abdominal diameter (SAD) or supine abdominal height is a simple anthropometric measure shown to be a marker of insulin resistance. SAD is measured after normal expiration at the level of iliac crest while in the supine position with bent knees on a firm examination table and without clothes in the measurement area. The measurement is performed with the Holtain-Kahn abdominal caliper. |
| Body fat (%) | Day 85 | Body fat mass in kilograms (kg) and weight in kilograms (kg) will be combined to report Percent body fat in (kg/kg)\*100 (%) |
| Concentration of Lipokin in plasma | Day 85 | 12,13-diHOME (12,13-Dihydroxyoctadec-9-enoic acid) \[pmol/mL\] |
| Questionnaire about Appetite (AEBQ) | Day 85 | The Adult Eating Behavior Questionnaire (Hunot et al. 2016) about perception of hunger and satiety including ravenousness appetite and snacking habits will be performed throughout the study. AEBQ is a questionnaire measuring 8 different appetitive traits. Enjoyment of food Emotional over-eating Emotional under-eating Food fussiness Food responsiveness Slowness in eating Hunger Satiety responsiveness Scale: 5-point Likert scale: Strongly disagree =1 Disagree =2 Neitheragree nor disagree =3 Agree =4 Strongly agree =5 |
| Concentration of lipid profile in serum | Day 85 | Concentration of Cholesterol \[mg/dL\], triglycerides \[mg/dL\], LDL-cholesterol \[mg/dL\], HDL-cholesterol \[mg/dL\] |
Countries
Germany
Outcome results
None listed