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

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ClinicalTrials.gov Identifier: NCT03853603
Recruitment Status : Completed
First Posted : February 25, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Weight Loss Dietary Supplement: Santa herba Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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
Actual Study Start Date : February 15, 2019
Actual Primary Completion Date : August 12, 2019
Actual Study Completion Date : August 12, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Maltodextrin
Dietary Supplement: Placebo
Maltodextrin; 400 mg/day. 2 capsules/day; 1 capsule twice daily with the main meals (lunch and dinner)

Active Comparator: Santa herba extract
Santa herba extract
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)




Primary Outcome Measures :
  1. Body weight [ Time Frame: day 85 ]
    electronic scale


Secondary Outcome Measures :
  1. Body fat (%) [ 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 (%)

  2. BCM/ECM index [ Time Frame: Day 85 ]
    Body cell mass (BCM) in kg and extracellular mass (ECM) in kg will be combined to report BCM/ECM index

  3. Waist-hip ratio (WHR) [ Time Frame: Day 85 ]
    Waist circumference in centimetre (cm) and hip circumference in centimetre (cm) will be combined to report WHR in cm/cm

  4. Sagittal abdominal diameter (SAD) [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.

  5. Concentration of lipid profile in serum [ Time Frame: Day 85 ]
    Concentration of Cholesterol [mg/dL], triglycerides [mg/dL], LDL-cholesterol [mg/dL], HDL-cholesterol [mg/dL]

  6. Concentration of Lipokin in plasma [ Time Frame: Day 85 ]
    12,13-diHOME (12,13-Dihydroxyoctadec-9-enoic acid) [pmol/mL]

  7. Questionnaire about Appetite (AEBQ) [ 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




Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03853603


Locations
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Germany
BioTeSys GmbH
Esslingen, Germany, 73728
Sponsors and Collaborators
Mibelle AG
Investigators
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Principal Investigator: Daniel Menzel, MD BioTeSys GmbH
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Responsible Party: Mibelle AG
ClinicalTrials.gov Identifier: NCT03853603    
Other Study ID Numbers: BTS1235/18
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mibelle AG:
lipid profile
12,13-diHOME
Additional relevant MeSH terms:
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Body Weight
Overweight
Weight Loss
Body Weight Changes