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

Weight Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03853603
• Other study ID #: BTS1235/18
• Status: Completed
• Phase: N/A
• Start date: February 15, 2019
• Est. completion date: August 12, 2019

Study information

• Verified date: August 2019
• Source: Mibelle AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 12, 2019
• Est. primary completion date: August 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Body Weight
• Overweight
• Weight Loss

Intervention

Dietary Supplement:
• Santa herba
Santa herba dry extract; 400 mg/day. 2 capsules/day; 1 capsule twice daily with the main meals (lunch and dinner)
• Placebo
Maltodextrin; 400 mg/day. 2 capsules/day; 1 capsule twice daily with the main meals (lunch and dinner)

Locations

Country	Name	City	State
Germany	BioTeSys GmbH	Esslingen

Sponsors (1)

Lead Sponsor	Collaborator
Mibelle AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	electronic scale	day 85
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Concentration of lipid profile in serum	Concentration of Cholesterol [mg/dL], triglycerides [mg/dL], LDL-cholesterol [mg/dL], HDL-cholesterol [mg/dL]	Day 85
Secondary	Concentration of Lipokin in plasma	12,13-diHOME (12,13-Dihydroxyoctadec-9-enoic acid) [pmol/mL]	Day 85
Secondary	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