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Clinical Trials/NCT03853603
NCT03853603CompletedNot Applicable

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

Mibelle AG2 sites in 1 country50 target enrollmentStarted: February 15, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Mibelle AG
Enrollment
50
Locations
2
Primary Endpoint
Body weight

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
25 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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)

Arms & Interventions

Placebo

Placebo Comparator

Maltodextrin

Intervention: Placebo (Dietary Supplement)

Santa herba extract

Active Comparator

Santa herba extract

Intervention: Santa herba (Dietary Supplement)

Outcomes

Primary Outcomes

Body weight

Time Frame: day 85

electronic scale

Secondary Outcomes

  • BCM/ECM index(Day 85)
  • Concentration of lipid profile in serum(Day 85)
  • Questionnaire about Appetite (AEBQ)(Day 85)
  • Body fat (%)(Day 85)
  • Waist-hip ratio (WHR)(Day 85)
  • Sagittal abdominal diameter (SAD) [cm](Day 85)
  • Concentration of Lipokin in plasma(Day 85)

Investigators

Sponsor
Mibelle AG
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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