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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
50
Santa herba dry extract; 400 mg/day. 2 capsules/day; 1 capsule twice daily with the main meals (lunch and dinner)
Maltodextrin; 400 mg/day. 2 capsules/day; 1 capsule twice daily with the main meals (lunch and dinner)
BioTeSys GmbH
Esslingen am Neckar, Germany
Body weight
electronic scale
Time frame: day 85
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 (%)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Day 85
Concentration of lipid profile in serum
Concentration of Cholesterol \[mg/dL\], triglycerides \[mg/dL\], LDL-cholesterol \[mg/dL\], HDL-cholesterol \[mg/dL\]
Time frame: Day 85
Concentration of Lipokin in plasma
12,13-diHOME (12,13-Dihydroxyoctadec-9-enoic acid) \[pmol/mL\]
Time frame: Day 85
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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
Time frame: Day 85