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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Maltodextrin |
|
| Santa herba extract | Active Comparator | Santa herba extract |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Santa herba | Dietary Supplement | Santa herba dry extract; 400 mg/day. 2 capsules/day; 1 capsule twice daily with the main meals (lunch and dinner) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | electronic scale | day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Body fat (%) | Body fat mass in kilograms (kg) and weight in kilograms (kg) will be combined to report Percent body fat in (kg/kg)*100 (%) | Day 85 |
| BCM/ECM index | Body cell mass (BCM) in kg and extracellular mass (ECM) in kg will be combined to report BCM/ECM index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Menzel, MD | BioTeSys GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioTeSys GmbH | Esslingen am Neckar | 73728 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34255555 | Derived | 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. |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Dietary Supplement | Maltodextrin; 400 mg/day. 2 capsules/day; 1 capsule twice daily with the main meals (lunch and dinner) |
|
| Day 85 |
| Waist-hip ratio (WHR) | Waist circumference in centimetre (cm) and hip circumference in centimetre (cm) will be combined to report WHR in cm/cm | Day 85 |
| Sagittal abdominal diameter (SAD) [cm] | 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. | Day 85 |
| Concentration of lipid profile in serum | Concentration of Cholesterol [mg/dL], triglycerides [mg/dL], LDL-cholesterol [mg/dL], HDL-cholesterol [mg/dL] | Day 85 |
| Concentration of Lipokin in plasma | 12,13-diHOME (12,13-Dihydroxyoctadec-9-enoic acid) [pmol/mL] | Day 85 |
| Questionnaire about Appetite (AEBQ) | 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 | Day 85 |