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

Not Applicable

Completed

• Conditions: Weight Loss
• Interventions: Dietary Supplement: Santa herba; Dietary Supplement: Placebo

• Registration Number: NCT03853603
• Lead Sponsor: Mibelle AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-12
• Study Start: 2019-02-15
• Study First Submitted QC: 2019-02-22
• Study First Posted: 2019-02-25
• Status Verified: 2019-08
• Primary Completion: 2019-08-12
• Study Completion: 2019-08-12
• Last Update Submitted: 2019-08-13
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Santa herba extract	Santa herba	Santa herba extract
Placebo	Placebo	Maltodextrin

Primary Outcome Measures

Name	Time	Method
Body weight	day 85	electronic scale

Secondary Outcome Measures

Name	Time	Method
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
Concentration of lipid profile in serum	Day 85	Concentration of Cholesterol \[mg/dL\], triglycerides \[mg/dL\], LDL-cholesterol \[mg/dL\], HDL-cholesterol \[mg/dL\]
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
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 (%)
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.
Concentration of Lipokin in plasma	Day 85	12,13-diHOME (12,13-Dihydroxyoctadec-9-enoic acid) \[pmol/mL\]

Trial Locations

Locations (1)

BioTeSys GmbH; 🇩🇪 Esslingen, Germany