Clinical Study to Investigate the Effects of a Food Supplement Santa Herba Extract on Weight Loss in Overweight Women

Study Overview
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Brief Summary
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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.

Official Title
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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
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Weight Loss

Intervention / Treatment
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* Dietary Supplement: Santa herba
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Maltodextrin | Dietary Supplement: Placebo<br>* Maltodextrin; 400 mg/day. 2 capsules/day; 1 capsule twice daily with the main meals (lunch and dinner)<br>|
| Active Comparator: Santa herba extract<br>Santa herba extract | Dietary Supplement: Santa herba<br>* Santa herba dry extract; 400 mg/day. 2 capsules/day; 1 capsule twice daily with the main meals (lunch and dinner)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | electronic scale | day 85 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lipid profile, 12,13-diHOME