BioTeSys GmbH
Esslingen am Neckar, 73728, Germany
NCT Number: NCT03853603
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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Notify Me25 year–60 year
Female
Interventional
Not applicable
Esslingen am Neckar, 73728, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: day 85
electronic scale
Time frame: 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 (%)
Time frame: Day 85
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 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) 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 Cholesterol [mg/dL], triglycerides [mg/dL], LDL-cholesterol [mg/dL], HDL-cholesterol [mg/dL]
Time frame: Day 85
12,13-diHOME (12,13-Dihydroxyoctadec-9-enoic acid) [pmol/mL]
Time frame: 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
Mibelle AG
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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